The study of the physical and chemical properties of a drug and its dosage form as related to the onset, duration, and intensity of its action.
The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.
Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.
Dynamic and kinetic mechanisms of exogenous chemical and DRUG LIBERATION; ABSORPTION; BIOLOGICAL TRANSPORT; TISSUE DISTRIBUTION; BIOTRANSFORMATION; elimination; and DRUG TOXICITY as a function of dosage, and rate of METABOLISM. LADMER, ADME and ADMET are abbreviations for liberation, absorption, distribution, metabolism, elimination, and toxicology.
The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action.
The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)
Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.
Categorical classification of MENTAL DISORDERS based on criteria sets with defining features. It is produced by the American Psychiatric Association. (DSM-IV, page xxii)
A plant genus of the family POLYGONACEAE that is used as an EDIBLE GRAIN. Although the seeds are used as cereal, the plant is not one of the cereal grasses (POACEAE).
Congenital malformation characterized by MICROGNATHIA or RETROGNATHIA; GLOSSOPTOSIS and CLEFT PALATE. The mandibular abnormalities often result in difficulties in sucking and swallowing. The syndrome may be isolated or associated with other syndromes (e.g., ANDERSEN SYNDROME; CAMPOMELIC DYSPLASIA). Developmental mis-expression of SOX9 TRANSCRIPTION FACTOR gene on chromosome 17q and its surrounding region is associated with the syndrome.
Facilities for the preparation and dispensing of drugs.
The practice of compounding and dispensing medicinal preparations.
Formal instruction, learning, or training in the preparation, dispensing, and proper utilization of drugs in the field of medicine.
The process of finding chemicals for potential therapeutic use.
Volume of biological fluid completely cleared of drug metabolites as measured in unit time. Elimination occurs as a result of metabolic processes in the kidney, liver, saliva, sweat, intestine, heart, brain, or other site.
7-Hydroxycoumarins. Substances present in many plants, especially umbelliferae. Umbelliferones are used in sunscreen preparations and may be mutagenic. Their derivatives are used in liver therapy, as reagents, plant growth factors, sunscreens, insecticides, parasiticides, choleretics, spasmolytics, etc.
Closed vesicles of fragmented endoplasmic reticulum created when liver cells or tissue are disrupted by homogenization. They may be smooth or rough.
The time it takes for a substance (drug, radioactive nuclide, or other) to lose half of its pharmacologic, physiologic, or radiologic activity.
The main structural component of the LIVER. They are specialized EPITHELIAL CELLS that are organized into interconnected plates called lobules.

Flow cytometry in the preclinical development of biopharmaceuticals. (1/102)

Novel biomarkers are often required in the preclinical development of biopharmaceuticals in order to characterize pharmacologic and toxicologic effects and to establish pharmacodynamic and pharmacokinetic relationships. Flow cytometry is uniquely suited for measurement of these biomarkers. Large numbers of single cells in a heterogeneous population can be rapidly identified and characterized with high accuracy and reproducibility. Cells are not damaged by the detection system and can be subsequently sorted for further morphologic or functional analysis. The availability of clinical instruments and a wide range of fluorescent probes have made this technology applicable for use in toxicologic clinical pathology. Flow cytometry has played an integral role in the development of a monoclonal antibody to human CD4 (keliximab, IDEC-CE9.1, SB 210396). Lymphocyte subset analysis and assays for expression, coating, and modulation of human CD4 were used for sequential assessment of the pharmacologic activity of keliximab in transgenic mice expressing human CD4.  (+info)

Molecular pathology in the preclinical development of biopharmaceuticals. (2/102)

Advances in cell and molecular biology have engendered a wide range of techniques that can be used to study the molecular events that underlie the cause of disease, thus producing a new field of study called "molecular pathology." These techniques can be either slide-based or non-slide-based (solution-based). The slide-based techniques include immunohistochemistry, in situ hybridization, and in situ polymerase chain reaction; pathologists play a unique role in the administration of these techniques because of their ability to interpret the end product (i.e., the slide). In this manuscript, we briefly discussed the use and impact of these slide-based techniques within all phases of drug development in the pharmaceutical industry.  (+info)

The pathologist and toxicologist in pharmaceutical product discovery. (3/102)

Significant change is occurring in the drug discovery paradigm; many companies are utilizing dedicated groups from the toxicology/ pathology disciplines to support early stage activities. The goal is to improve the efficiency of the discovery process for selecting a successful clinical candidate. Toxicity can be predicted by leveraging molecular techniques via rapid high-throughput, low-resource in vitro and in vivo test systems. Several important activities help create a platform to support rapid development of a new molecular entity. The proceedings of this symposium provide excellent examples of these applied concepts in pharmaceutical research and development. Leading biopharmaceutical companies recognize that a competitive advantage can be maintained via rapid characterization of animal models, the cellular identification of therapeutic targets, and improved sensitivity of efficacy assessment. The participation of the molecular pathologist in this quest is evolving rapidly, as evidenced by the growing number of pathologists that interact with drug discovery organizations.  (+info)

Biological activity of catecholamines covalently linked to synthetic polymers: proof of immobilized drug theory. (4/102)

l-Isoproterenol was covalently coupled via an azo linkage to soluble copolypeptides of molecular weight 1500 and 10,000 containing an aromatic amine. The polymeric azo-isoproterenol derivatives were purified by gel chromatography which reduced contamination by the parent isoproterenol to undetectable levels (i.e., less than 0.01%) and by 6-aminoisoproterenol to less than 0.4%. Both polymeric isoproterenol derivatives were found to elicit positive chronotropic responses in isolated perfused guinea pig hearts. The mean effective doses (ED50S) for the 1500 and 10,000 molecular weight derivatives were within 1.3 and 2.0 orders of magnitude, respectively, of the ED50 of l-isoproterenol. The responses cannot be attributed to free isoproterenol because this drug could not be detected in our preparations. Neither can the observed biological activity be attributed to 6-aminoisoproterenol, since this compound's dose-response is shifted 3 orders of magnitude to the right of l-isoproterenol and 1-2 orders of magnitude to the right of the polymeric derivatives. Inotropic response decay times in isolated cat papillary muscles following washouts indicate that the polymer-bound drug does not diffuse into the muscle tissues. We feel that our findings demonstrate that under controlled conditions the catecholamines can retain biological activity while covalently bound to a polymeric support.  (+info)

The dopamine transporter and cocaine medication development: drug self-administration in nonhuman primates. (5/102)

Despite intensive medication development efforts, no effective pharmacotherapy for cocaine abuse has demonstrated efficacy for long-term use. Given the obvious importance of the dopamine transporter in the addictive properties of cocaine, the development and use of compounds that target the dopamine transporter represents a reasonable approach for the pharmacological treatment of cocaine abuse. The therapeutic approach of replacement or substitute agonist medication has been successful, as shown with methadone maintenance for heroin dependence and nicotine replacement for tobacco use. A number of preclinical studies with dopamine transporter inhibitors provide evidence that substitute agonists may be used effectively to reduce cocaine use. Nonhuman primate models of drug self-administration provide a rigorous, systematic approach to characterize medication effectiveness in subjects with a documented history of drug use. Several cocaine analogs and other dopamine transporter inhibitors, including analogs of GBR 12909 and WIN 35,065-2, have been shown to reduce cocaine self-administration in nonhuman primates. A possible limitation to the use of selective dopamine transporter inhibitors as medications is their potential for abuse liability given their demonstrated reinforcing effects in nonhuman primates. However, limited reinforcing properties in the context of treatment programs may be advantageous, contributing to improved patient compliance and enhanced medication effectiveness. Moreover, pharmacokinetic properties that result in slow onset and long duration of action may enhance their effectiveness to reduce cocaine use while limiting their abuse liability.  (+info)

The chemical and physical stability of a 1:1 mixture of propofol and methohexital. (6/102)

Anesthetic drugs are frequently mixed or coadministered to optimize anesthetic effects while minimizing adverse effects. Methohexital advantages include its low cost and rapid onset, while propofol provides improved airway anesthesia and extremely rapid clearance from the plasma. Therefore, a mixture of these agents might well be superior to either drug given alone. We wished to determine whether a mixture of methohexital and propofol is chemically and physically stable. A 1:1 mixture of propofol 10 mg/ml and methohexital was prepared. At times varying from 0 to 48 hours, mixtures with an internal standard of thymol kept at room temperature were thrice extracted with a 2:1 v/v mixture of diethyl ether:pentane, dried under nitrogen, and treated overnight with bis-trimethylsilyl-trifluoroacetamide. The resultant derivatives were transferred to microsample vials and analyzed by GC-MS. Drug stability was quantified by electronic integration of peak areas representing characteristic ions for each drug. For each sample, the peak area of the methohexital ion (m/z 239) or propofol ion (m/z 235) relative to the corresponding thymol ion (m/z 207) served as an index of the concentration of the drug in the sample. At times varying from 0 to 48 hours, mixtures without thymol were used to determine mean droplet size of the particles. This was accomplished using both an Accusizer and a Nicomp 370 Particle Sizer. One way ANOVA tested for significant changes in drug concentrations and mean particle size as a function of time. There was no significant breakdown of propofol or methohexital when combined in a 1:1 mixture and allowed to stand for 48 hours, nor was there an increase in particle size suggestive of emulsion instability. We concluded that a 1:1 mixture of propofol and methohexital was stable up to 48 hours after mixing.  (+info)

Milestones in chloroplast genetic engineering: an environmentally friendly era in biotechnology. (7/102)

Chloroplast genomes defied the laws of Mendelian inheritance at the dawn of plant genetics, and continue to defy the mainstream approach to biotechnology, leading the field in an environmentally friendly direction. Recent success in engineering the chloroplast genome for resistance to herbicides, insects, disease and drought, and for production of biopharmaceuticals, has opened the door to a new era in biotechnology. The successful engineering of tomato chromoplasts for high-level transgene expression in fruits, coupled to hyper-expression of vaccine antigens, and the use of plant-derived antibiotic-free selectable markers, augur well for oral delivery of edible vaccines and biopharmaceuticals that are currently beyond the reach of those who need them most.  (+info)

Multigene engineering: dawn of an exciting new era in biotechnology. (8/102)

Development of a rice variety enriched in provitamin A, the accumulation of polyhydroxybutyrate polyester in Arabidopsis nuclear transgenic plants (with enzymes targeted to chloroplasts in both), and the expression of bacterial operons via the chloroplast genome are recent landmark achievements in multigene engineering. Hyper-expression of transgenes has resulted in the formation of insecticidal protein crystals or inclusion bodies of pharmaceutical proteins in transgenic chloroplasts, achieving the highest level of transgene expression ever reported in transgenic plants. These achievements illustrate the potential of multigene engineering to realize benefits of the post-genomic revolution.  (+info)

April saw the return of SOLVOs Meet the Experts conference series to the West Coast US, with a three-day event held in South San Francisco. Transporter scientists from industry and academia converged on the Embassy Suites to discuss the latest science in the field, including keynote talks by Dr Les Benet on the Biopharmaceutics Drug Disposition Classification System (BDDCS), the rule of 5 and druggability, Dr Ayman El-Kattan on the Extended Clearance Classification System (ECCS) and Dr Adrian Ray who spoke about Transporters as clinically relevant mediators of drug toxicity. In addition, for the first time outside of Europe, the event included a pre-conference workshop held by SOLVO scientists which covered the practical aspects of conducting transporter studies, including assay selection, bioanalytics, and data analysis. We would like to thank all attendees, as well as the speakers and sponsors, MilliporeSigma, Simulations Plus, and Qualyst Transporter Solutions, for making this another ...
TY - JOUR. T1 - PHARMACOKINETICS OF ORALLY-ADMINISTERED HEXOBARBITAL IN PLASMA AND SALIVA OF HEALTHY-SUBJECTS. AU - VANDERGRAAFF, M. AU - VERMEULEN, NPE. AU - HEIJ, P. AU - Boeijinga, J K. AU - Breimer, D D. PY - 1986. Y1 - 1986. U2 - 10.1002/bdd.2510070307. DO - 10.1002/bdd.2510070307. M3 - Article. VL - 7. SP - 265. EP - 272. JO - Biopharmaceutics & Drug Disposition. JF - Biopharmaceutics & Drug Disposition. SN - 0142-2782. IS - 3. ER - ...
Meet leading Experts at Biopharmaceutics 2018, Montreal, Canada, Clinical Trials in Biopharmaceutics, Drug Delivery Systems for Biopharmaceuticals, Biopharmaceutical Companies & Market analysis, BA/BE studies for Biopharmaceuticals
BIOPHARMACEUTICS AND PHARMACOKINETICS PDF - Applied Biopharmaceutics & Pharmacokinetics, 7e. Leon Shargel, Andrew B.C. Search Textbook Autosuggest Results.
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The definitive book on the neutralization of recombinant biopharmaceuticals. Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects.. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present.. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and ...
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Our test of price-taking behavior looks at the choice of capacity rather than the choice of output. It is motivated by a complete spot markets model in which goods are distinguished by the selling probabilities in addition to other characteristics. When output is explained by total man-hours and a capacity utilization proxy, the coefficient of the first variable is the elasticity of capacity with respect to fixed labor. Under competition and risk neutrality this coefficient is equal to an average labor share. We use this observation to interpret Abbot-Griliches-Hausmans regressions and to argue that once the capacity utilization proxy is included in the regression, Halls data at the manufacturing level fail to reject the joint hypothesis of competition and risk neutrality. It is also argued that the coefficient of total man-hours does not tell us anything about monopoly power once the capacity utilization proxy is omitted from the regression. ...
Get this from a library! Manual of laboratory pharmacokinetics : experiments in biopharmaceutics, biochemical pharmacology, and pharmacokinetics, with a consideration of relevant instrumental and chromatographic techniques. [Stephen H Curry; Robin Whelpton]
Read chapter 7 of Applied Biopharmaceutics & Pharmacokinetics, 7e online now, exclusively on AccessPharmacy. AccessPharmacy is a subscription-based resource from McGraw Hill that features trusted pharmacy content from the best minds in the field.
9780071375504 Our cheapest price for Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition is $1.09. Free shipping on all orders over $35.00.
Introduction to the Physical Pharmacy and Biopharmaceutics (PPB) section of AAPS and Careers in the Pharmaceutical and Biotech Industries. PPB Section. Outline. Part I AAPS Overview and Student Benefits AAPS PPB section PPB ambassador program Part II Career Tips and Opportunities Slideshow...
Meet Top Pharma Industry Professionals, Researchers, Scientists, Sponsors and Exhibitors from USA, UK, Europe, Asia, and Middle East at Top Pharma conferences, Pharmaceutical Conferences and Biopharmaceutics Meeting and Events, EuroSciCon Conference, EuroSciCon Conference World pharma 2021 will be conducted on theme: Exploring the latest research in Pharma and Biopharma
http://ir.navidea.com following the event. About Navidea Biopharmaceuticals Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its ManoceptTM platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navideas Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc 99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. Navideas strategy is to deliver superior ...
Biopharmaceuticals are pharmaceutical products consisting of (glyco)proteins. Nowadays a substantial part of the FDA-approved drugs belong to this class of drugs. Biopharmaceuticals deserve special attention as they have a number of characteristics that set them aside from low molecular weight drugs.Their activity depends on their complicated shape based on secondary, tertiary and (sometimes) quaternary structures. These structures cannot be fully defined with our present set of analytical techniques and approaches for potency testing. They often are the same as (or closely resemble) endogenous proteins. This means that in safety testing and clinical test programs questions have to be addressed regarding species specific responses, selection of dosing schedules and route of administration, and the possible occurrence of immunogenicity. As the conformational structure of a protein is easily disturbed, formulation and handling of biopharmaceuticals needs special attention in order to optimize the ...
www.MOLUNA.de Immunogenicity of Biopharmaceuticals [4173115] - Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune
Biopharmaceuticals multiple choice questions(MCQs) and answers. These Biopharmaceuticals objective questions with answers are important for competitive exams. Gkseries provides the most important questions answers, question bank, quiz set. It is set 1.
Levothyroxine Sodium with NDC 47781-657 is a a human prescription drug product labeled by Alvogen, Inc.. The generic name of Levothyroxine Sodium is levothyroxine sodium.
China Steroid Levothyroxine Sodium for Weight Loss T4, Find details about China T4, Levothyroxine Sodium from Steroid Levothyroxine Sodium for Weight Loss T4 - Wuhan Yuancheng Gongchuang Technology Co., Ltd.
Informing Additive Manufacturing (AM) technology adoption decisions, this paper investigates the relationship between build volume capacity utilisation and efficient technology operation in an inter-process comparison of the costs of manufacturing a complex component used in the packaging industry. Confronting the reported costs of a conventional machining and welding pathway with an estimator of the costs incurred through an AM route utilising Direct Metal Laser Sintering (DMLS), we weave together four aspects: optimised capacity utilisation, ancillary process steps, the effect of build failure and design adaptation. Recognising that AM users can fill unused machine capacity with other, potentially unrelated, geometries, we posit a characteristic of fungible build capacity. This aspect is integrated in the cost estimation framework through computational build volume packing, drawing on a basket of sample geometries. We show that the unit cost in mixed builds at full capacity is lower than in ...
Initiated First of Two Pivotal Clinical Trials Planned to Support BLA Filing for ALD403 in Migraine Prevention. Two ALD403 Data Readouts Anticipated in 1Q16. BOTHELL, Wash., Nov. 05, 2015 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (Alder) (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, Cushings disease, Congenital Adrenal Hyperplasia and autoimmune and inflammatory diseases, today provided recent corporate highlights and reported its financial results for the third quarter ended September 30, 2015.. We continue to execute on our accelerated clinical development plan for ALD403. We recently initiated the first of two pivotal clinical trials aimed at a future BLA filing of ALD403. In addition, we completed enrollment in the Phase 2b clinical trial of ALD403 in patients with chronic migraine and look forward to reporting the top-line data from this trial along with the data from the Phase 1 quarterly ...
Introduction (John Carpenter). Part I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques.. 1. The Structure of Biological Therapeutics (Sherry Martin-Moe, Y. John Wang, Tim Osslund, Tahir Mahmood, Rohini Deshpande, and Susan Hershenson).. 2. Chemical Instability in Peptide and Protein Pharmaceuticals (Elizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell Manning).. 3. Physical Instability in Peptide and Protein Pharmaceuticals (Byeong Chang and Bernice Yang).. 4. Immunogenicity of Therapeutic Proteins (Steven J Swanson).. 5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development (Bernardo Perez-Ramirez, Nicholas Guziewicz and Robert Simler).. 6. Formulation Development of Phase I/II Biopharmaceuticals: An Efficient and Timely Approach (Nicholas W. Warne).. 7. Late Stage Formulation Development and Characterization of Biopharmaceuticals (Adeolla O Grillo).. 8. An ...
Biopharmaceutics is a kind of organic resource that uses protein, starch, vitamins, minerals and other raw materials to produce drugs through microbial fermentation. Its residue contains rich mycelium and residual organic and inorganic substances. Bio-pharmaceutical residue is one of the most serious pollution sources in bio-pharmaceutical enterprises. Over the years, some enterprises have tried to reuse the residue and achieved some results, but most of them are directly discharged as waste, bringing pollution to the surrounding environment. Biopharmaceutical fermentation is a hot topic in the research of biopharmaceutical modernization in recent years. It is a perfect combination of modern biotechnology and traditional biopharmaceutical advantages, and is one of the important means to improve the material basis of biopharmaceutical efficacy. Based on membrane separation technology, this paper focuses on bio-fermentation of bio-pharmaceutical residues, and reviews from aerobic fermentation and ...
Request sample of market research report on Sk Biopharmaceuticals Co Ltd Product Pipeline Review 2016. Explore detailed TOC, tables and figures of Sk Biopharmaceuticals Co Ltd Product Pipeline Review 2016.
Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of monoclonal antibodies (mAbs) and other proteins. In Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols, experts in the field provide readers with production and characterization protocols of glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. The volume is divided in four complementary parts dealing with glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complexes characterization, and PK/PD assays for therapeutic antibodies. Written in the highly successful Methods in Molecular Biology(TM) series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Glycosylation Engineering of ...
Kythera Biopharmaceuticals Announces $40M Financing LOS ANGELES -- Kythera Biopharmaceuticals, Inc. (Kythera), a privately-held biotechnology company, announced a $40 million C round financing led
Chengdu Aslee Biopharmaceuticals, Inc was specialized in conducting research, production and sale of biopharmaceuticals, and highly-valued fine chemicals, and devoted to the research and development, custom synthesis and process as well as technical consultancy in pharmaceuticals, drug intermediates and organic-electric materials. The company has 600 square meter of research lab and scale up plants, and be able to realize the whole process of the sample production and quality control together with standard management stock room. And the company can manufacture the product from gram to kilogram scale. On the other hand, the company has already established the long-term partner relationship with some of nationally known institutes and universities such as shanghai Institute of Organic Chemistry, Chinese Academy of Science, Nankai University, Sichuan University and Southwest University, and are committed to self independent research, development and production of high-tech of drug intermediates and ...
...NEW YORK Oct. 19 /- Reportlinker.com announces that a ne...a href http://www.reportlinker.com/p0316266/Downstream-Processing-in...a href http://www.reportlinker.com/p0316266/Downstream-Processing-in...Downstream Processing in Biopharmaceuticals - Increased Demand for Bio...,Reportlinker,Adds,Downstream,Processing,in,Biopharmaceuticals,-,Increased,Demand,for,Biologics,Drives,Improvement,in,Cost,-effective,Purification,Technologies,biological,advanced biology technology,biology laboratory technology,biology device technology,latest biology technology
The global❝U.S. Non-oncology Biopharmaceuticals Market❞ report by wide-ranging study of the U.S. Non-oncology Biopharmaceuticals industry which covers comprehensively all aspects of…. Read More » ...
Biopharmaceuticals can be summarized as any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man. Prior to their commercial release in this highly regulated present-day market, biopharmaceuticals need to be thoroughly tested for their efficacy, stability, presence of contaminants and lot/batch variations as per pharmacopeial guidelines set by regulatory authorities like USP, EMA, FDA etc ...
Biopharmaceuticals can be summarized as any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man. Prior to their commercial release in this highly regulated present-day market, biopharmaceuticals need to be thoroughly tested for their efficacy, stability, presence of contaminants and lot/batch variations as per pharmacopeial guidelines set by regulatory authorities like USP, EMA, FDA etc ...
Federal regulations concerning the safety and efficacy of biopharmaceuticals require the implementation of a comprehensive toolbox of physicochemical and biological characterization methods. In order to demonstrate consistent overall structure, even minute differences in primary structure and post‑translational modifications (PTMs) have to be detectable in therapeutic proteins. Because of their remarkable capability of revealing small changes in molecular structure, high performance liquid chromatography (HPLC) and mass spectrometry (MS) rate among the most powerful technologies for comprehensive protein analysis. This article details the potential of both methods with regard to revealing methionine oxidation, a chemical modification that may be induced during downstream processing and storage of biopharmaceuticals. The benefits and limitations of bottom-up, middle-down, and top‑down HPLC-MS analysis will be demonstrated for the detection of oxidation variants in a therapeutic monoclonal antibody
More and more therapeutic proteins are developed for an administration by inhalation to treat respiratory diseases. PEGylation is an interesting approach for sustaining the residence time of these biopharmaceuticals in the lungs and thereby decrease the frequency of administration and the daily burden of inhalation therapies. Several PEGylated proteins have been delivered to the lungs in rodents and shown to be retained in the respiratory tract for longer periods than unconjugated counterparts. Mechanisms involved in their pulmonary retention might include increased molecular size, mucoadhesion, enhanced proteolytic resistance and escape from the uptake by alveolar macrophages. Pulmonary delivery of PEGylated peptides and proteins is also interesting as a non-invasive route of administration of long-acting biopharmaceuticals to the bloodstream. However, PEGylation decreases the systemic absorption of the compounds, especially when the PEG size is large. This review presents the recent work ...
... LONDON Oct. 7 /- Morria Biopharmaceuticals Plc abi...Morrias lead compounds significantly reduced the levels of thefollow... We are pleased by the wide range of divergent inflammatory mediators...Specifically several of the inflammatory mediators assayed have been...,Morria,Biopharmaceuticals,Plc,Announces,Results,From,its,Pre-Clinical,Screening,of,Novel,Anti-Inflammatory,Compounds,biological,advanced biology technology,biology laboratory technology,biology device technology,latest biology technology
Biopharmaceuticals in Plants: Toward the Next Century of Medicine by Kathleen Laura Hefferon starting at $90.04. Biopharmaceuticals in Plants: Toward the Next Century of Medicine has 2 available editions to buy at Alibris
This blog is neither intended to be nor is investment advice. The author of this blog (the Author) is not a registered investment advisor. Under no circumstances should any content from this blog be used or interpreted as a recommendation of a trade or investment in Provectus Biopharmaceuticals, Inc. Trading and investing can be hazardous to your wealth, health or both. Any investment decision must, in all cases and without exception, be made by the reader or by his or her registered investment advisor. This blog is only and strictly for educational and informational purposes. The Author may have a position in Provectus Biopharmaceuticals, Inc. at any given time that is not disclosed at the time of publication. All opinions expressed by the Author are subject to change without notice. You, the reader, should always obtain current information and perform the appropriate due diligence before making any investment or trading decision. All efforts are made to ensure the information contained in ...
Alder Biopharmaceuticals Inc Alder Biopharmaceuticals Inc (NASDAQ:ALDR) is having a fantastic day of trading in that shares of the companys stock were up
ValuEngine upgraded shares of Eiger Biopharmaceuticals (NASDAQ:EIGR) from a sell rating to a hold rating in a research report sent to investors on Sunday morning. Several other equities research analysts have also issued reports on EIGR. Oppenheimer reissued a buy rating and set a $34.00 target price on shares of Eiger Biopharmaceuticals in a research […]
This blog is neither intended to be nor is investment advice. The author of this blog (the Author) is not a registered investment advisor. Under no circumstances should any content from this blog be used or interpreted as a recommendation of a trade or investment in Provectus Biopharmaceuticals, Inc. Trading and investing can be hazardous to your wealth, health or both. Any investment decision must, in all cases and without exception, be made by the reader or by his or her registered investment advisor. This blog is only and strictly for educational and informational purposes. The Author may have a position in Provectus Biopharmaceuticals, Inc. at any given time that is not disclosed at the time of publication. All opinions expressed by the Author are subject to change without notice. You, the reader, should always obtain current information and perform the appropriate due diligence before making any investment or trading decision. All efforts are made to ensure the information contained in ...
Biopharmaceuticals are important treatment options for a variety of chronic and sometimes life-threatening diseases. Compared with the traditional small molecule drugs, biopharmaceuticals have specifi
The general aim of this thesis was to evaluate a newly designed and constructed miniaturized rotating disk apparatus for in vitro dissolution rate measurements of different drug substances from all of the classes in the Biopharmaceutical Classification System (BCS). The new equipment is based on a low volume flow-through cell of Plexiglas, a gold plated magnetic bar and a special designed press. The disk of drug substance (approx. 5 mg) is placed eccentrically in the bar. Rotation speeds were set with a graded magnetic stirrer. An external HPLC pump delivered a continuous flow of aqueous medium to the flow-through cell during dissolution testing.. A reversed phase high-performance liquid chromatography system using diode array detection (RP-HPLC-DAD) was coupled online to the new equipment. The injections from the miniaturized rotating disk outlet into the quantifying HPLC system were controlled by a six-position switching valve. The injection volumes from the valve and the autosampler, used for ...
BOTHELL, Wash., Sept. 21, 2016-- Alder BioPharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced the appointment of Nancy L. Boman, M.D., Ph.D. as senior vice president of regulatory affairs and pharmacovigilance. She holds a bachelor s degree, a medical degree and a Ph.D. in biochemistry from...
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy™ (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
/PRNewswire/ -- Alder Biopharmaceuticals Inc. today announced that Randall Schatzman, Ph.D., president and chief executive officer, will participate in a panel...
Alder Biopharmaceuticals Inc (NASDAQ:ALDR) has presented preclinical data on ALD1613, an anti-adrenocorticotropic hormone for the treatment of adrenal hyperplasia and Cushings disease. The presentation, entitled A Novel Anti-ACTH Antibody Neutralizes ACTH Activity and Reduces Glucocorticoids in Rats and Nonhuman Primates was made at Endo 2016, the Endocrine Societys 98th Annual Meeting in Boston, Massachusetts.. Click Here For More Market Exclusive Updates & Analysis. In the presentation, ALD1613 was noted to inhibit ACTH-induces cortisol secretion in a mouse adrenal cell line. It was also observed that ALD1613 administration in rats with artificially high ACTH and corticosterone level resulted in a high and durable reduction of plasma corticosterone levels. ALD1613 in non-human primates demonstrated a stable and durable reduction in plasma cortisol levels by over 50%.. Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder noted that existing therapeutic options for ...
SINTEF performs characterisation and production of biopharmaceuticals, mainly development of microbial production processes. Within medical technology and Nanomedicine, SINTEF focus on development of nanoparticles tailored for drug delivery, biosensors, and new solutions for therapy and diagnostics.
PAN Czytelnia Czasopism, Transgenic mammalian species, generated by somatic cell cloning, in biomedicine, biopharmaceutical industry and human nutrition/dietetics - recent achievements - Polish Journal of Veterinary Sciences
Excision BioTherapeutics, a life science company focused on the development and commercialization of advanced gene editing therapeutics for the treatment of life-threatening disease caused by neurotropic viruses, recently announced it has completed a $10 million seed round of financing, led by ARTIS Ventures. The investment will enable the company to enter into human clinical trials with its HIV-1 targeted CRISPR platform, giving Excision BioTherapeutics the first effort to fully remove/excise the HIV-1 genome from all human cells and tissues. In addition, Excision BioTherapeutics is extending this approach to other viruses by targeting their genetic elements, and eliminating them permanently from the patient. Regarding this development, Thomas Malcolm, Ph.D, Excision BioTherapeutics founder, president and CEO, stated Excisions mission has always been to advance gene editing therapeutics into safe and efficacious medicines that will eradicate or disrupt viral genes in human patients. The ...
Title:Surface Engineering of Fenofibrate Nanocrystals Using Nano-by-Design Multivariate Integration: A Biopharmaceutical and Pharmacokinetic Perspective. VOLUME: 18 Author(s):Sandip Gite, Pratik Kakade and Vandana Patravale*. Affiliation:Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai 400019, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai 400019, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai 400019. Keywords:Nano-by-Design, fenofibrate, nanosuspension, media milling, nanocrystals, dissolution.. Abstract:Introduction: Surface engineering of nanocrystals for improving the biopharmaceutical features is a multivariate process involving numerous formulation and process variables, thus making it a complicated process to get the desired biopharmaceutical quality profile. Nano-by-design is hereby ...
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Cite as Molly Redfield Ward, Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs), KEI Research Note 2010:3) A PDF version of this document is available here. Notes on the 2004… Continue Reading →. ...
Wheat, a tetany prone forage, and orchardgrass, a non-tetany prone forage, were cut at three stages of maturity to determine the magnesium availability in these forages for lambs. The forages were dried in forced air ovens and ground through a 2.5 cm screen. The nitrogen contents of the forages were not significantly different between forages but decreased quadratically with maturity in wheat (P < .Ol) and linearly in orchardgrass (P < .Ol). Nonprotein nitrogen was significantly higher in wheat than in orchardgrass. The magnesium content of the wheat was lower (P < .O1) than orchardgrass (.14 vs .21%). Magnesium content in wheat was similar at all maturities but decreased with maturity in orchardgrass. Potassium, calcium and phosphorous levels in the forages were similar between wheat and orchardgrass but decreased with advancing maturity in both forages.. In two metabolism trials with 18 wether lambs, the biological availability of magnesium was determined for the two forages cut at three ...
Thank you for your interest in attending the ISSX Webinar. This webinar is now full and registration is closed. A recording will be made available to ISSX Members later this month.. ISSX Members are invited to attend a free one-hour webinar on Wednesday, January 18 at 10:00 am ET US. Lipoidal or lipid permeability has been used to define the disposition characteristics of molecules (BDDCS) and these relationships can be extended through biopharmaceutics to actual pharmacological and toxicological outcome (pharmacodynamics). Moreover the same guiding principles can be used to understand the likely outcomes of metabolism. The relationship between lipoidal permeability and lipophilicity is due to the alkyl chain interior of the bilayer. Compounds have to have positive lipophilicity. Hydrogen bonding groups have to undergo desolvation when they move from an aqueous extracellular environment to the lipophilic interior of membranes. Hydrogen bonding and the removal of solvent thus represents, a large ...
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Funding Enables Existing Clinical Trials to Proceed as Company Joins Global Response with COVID-19 Program. PITTSBURGH - May 7, 2020 - Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, has received a $4 Million grant from the Commonwealth of Pennsylvania to continue clinical trials of its lead product candidate, ST266, in a wide range of diseases, including multiple ophthalmic indications. The funding will enable Noveome to shift its existing resources to support the companys recently launched COVID-19 program evaluating ST266 as a treatment for the cytokine storm-the severe inflammatory response often observed in COVID-19 infections.. While researchers around the world race to deliver a vaccine that will address this COVID-19 pandemic head on, we need a range of new therapeutics and diagnostics to stem the tide. This very timely funding will ...
Title:Formulation and Application of Biodegradable Nanoparticles Based Biopharmaceutical Delivery - An Efficient Delivery System. VOLUME: 22 ISSUE: 20. Author(s):Surajit Bhattacharjee, Biplab Sarkar, Ashish Ranjan Sharma, Priya Gupta, Garima Sharma, Sang-Soo Lee and Chiranjib Chakraborty. Affiliation:Institute For Skeletal Aging & Orthopedic Surgery, Hallym University-Chuncheon Sacred Heart Hospital, Chuncheon 200704, Republic of Korea., Department of Bio-informatics, School of Computer and Information sciences, Galgotias University, Greater Noida 201306, India.. Keywords:Biopharmaceutical, biodegradable, drug delivery, nanoparticle, polymer, nanocarriers, encapsulation.. Abstract:Biodegradable polymer based drug delivery has emerged as a promising and successful clinical tool for specific targeting and controlled drug release delivery system. Various other unique advantages associated with this delivery system include prolonged circulation, biocompatibility, degradation in nontoxic by-products ...
Sino Biopharmaceutical Limited operates in the Pharmaceutical Preparations sector. Sino Biopharmaceutical Limited is an investment holding company principally engaged in the medicine products business. The Company operates through three business segments. The Modernized Chinese Medicines and Chemical Medicines segment is engaged in the manufacture, sales and distribution of modernized Chinese medicine products and western medicine products. The Investment segment is engaged in long term investments. The Others segment is engaged in the provision of research and development activities and services to third parties, as well as related healthcare and hospital business. The Company is also involved in the property holding, the sales of health food, the manufacture and optometry of optical glasses, as well as the retail and wholesale of optical and auditory products through its subsidiaries.
TY - JOUR. T1 - Modifying the replication of geminiviral vectors reduces cell death and enhances expression of biopharmaceutical proteins in nicotiana benthamiana leaves. AU - Diamos, Andrew G.. AU - Mason, Hugh. PY - 2019/1/9. Y1 - 2019/1/9. N2 - Plants are a promising platform to produce biopharmaceutical proteins, however, the toxic nature of some proteins inhibits their accumulation. We previously created a replicating geminiviral expression system based on bean yellow dwarf virus (BeYDV) that enables very high-level production of recombinant proteins. To study the role of replication in this system, we generated vectors that allow separate and controlled expression of BeYDV Rep and RepA proteins. We show that the ratio of Rep and RepA strongly affects the efficiency of replication. Rep, RepA, and vector replication all elicit the plant hypersensitive response, resulting in cell death. We find that a modest reduction in expression of Rep and RepA reduces plant leaf cell death which, despite ...
The immunogenicity of biopharmaceuticals found in clinical practice remains an unsolved challenge in medication development. monoclonal antibodies, antidrug-antibodies, nonclinical, safety assessment, medication development, regulatory research Introduction The development RTA 402 of recombinant technology some 30 years back led to groundbreaking novel ways of medication advancement that allowed the creation of any protein-based medication in cell lifestyle. These protein-based biopharmaceuticals give essential advantages over traditional small-molecule medications, such as for example half-lives and incredibly high specificity longer. As opposed to little molecules, that are metabolized, healing protein are degraded to their constituent proteins. As a total result, most undesireable effects certainly are a total consequence of exaggerated pharmacodynamics.1 An unsolved problem in biopharmaceutical development is these protein ultimately become immunogenic in a few sufferers, provoking an immune ...
Keywords: receptor occupancy, pharmacodynamic biomarker, biopharmaceutical, stream cytometry, Compact disc80, Compact disc86, IGF1R Launch Biopharmaceuticals certainly are a fast developing course of therapeutics 1, 2, 3, 4. Evaluation of pharmacokinetics (PK) and pharmacodynamics (PD) can be an integral component of preclinical and scientific advancement 5, 6, 7. It enables establishment of PKCPD romantic relationships, which significantly facilitates collection of suitable CX-4945 dosages for the initial\in\human aswell as for the next scientific studies 8, 9, 10. While PK (publicity) evaluation is normally performed utilizing a quantitative immunoassay that methods the medication as the analyte 6, evaluation of its PD (influence on the mark) can be carried out by a number of different strategies, including measuring medication binding to the mark 11, 12, 13, 14, 15, and evaluating modulation of downstream signaling 16, 17, 18 or supplementary replies 8, 9, 19, 20. Biopharmaceuticals targeting ...
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Abecedni seznam revij:. Acta Chimica Slovenica (FT). Acta Pharmaceutica (BF, Knjižnica). Autoimmunity Reviews (KB). Bioorganic and Medicinal Chemistry (FK). Bioorganic and Medicinal Chemistry Letters (FK). Biopharmaceutics and Drug Disposition (BF). Chemical Resaearch in Toxicology (FK). Cosmetics and Toiletries (FT). European Journal of Medicinal Chemistry (FK). European Journal of Pharmaceutical Sciences (BF). Farmacevtski Vestnik (Knjižnica). Innovation in Pharmaceutical Technology (FT). International Journal of Pharmaceutics (BF). Isis (Knjižnica). Journal of Microencapsulation (FT). Journal of Natural Products (FB). Journal of Pharmacokinetics and Pharmacodynamics (BF). Kemija v šoli (FT). Medicina danes (Knjižnica). Medicinal Research Reviews (FK). Pharmaceutical Development and Technologyhttp://informahealthcare.com/loi/phd (FT). Pharmacoepidemiology and Drug Safety (SF). Pharmazeutische Industrie (FT). Scientia Pharmaceutica (FT). The International Journal of Pharmacy Practice ...
The problems with Chinas regional industrial overcapacity are often influenced by local governments. This study constructs a framework that includes the resource and environmental costs to analyze overcapacity using the non-radial direction distance function and the price method to measure industrial capacity utilization and market segmentation in 29 provinces in China from 2002 to 2014. The empirical analysis of the spatial panel econometric model shows that (1) the industrial capacity utilization in Chinas provinces has a ladder-type distribution with a gradual decrease from east to west and there is a severe overcapacity in the traditional heavy industry areas; (2) local government intervention has serious negative effects on regional industry utilization and factor market segmentation more significantly inhibits the utilization rate of regional industry than commodity market segmentation; (3) economic openness improves the utilization rate of industrial capacity while the internet ...
This notice announces the availability of a scheduled rotation in the FDA available to Pediatric pharmacology fellows in training in good standing in an established academic program. The primary goal of the rotation program is to introduce the fellows to regulations related to pediatric drug development and to application of clinical pharmacology and biopharmaceutics principles for regulatory decision making as well as advancing application of clinical pharmacology for dose selection, dosing recommendations and ultimately labeling.
About the Author: Brad Gillespie, PharmD. Trained as a clinical pharmacist, Brad has practiced in an industrial setting for the past 20-plus years. His initial role was as a clinical pharmacology and biopharmaceutics reviewer at FDA, followed by 15 years of leading early development programs in the pharma/biotech/nutritional industries. In addition to his industrial focus, he remains a registered pharmacist and enjoys mentoring drug development scientists and health professionals, as well as leading workshops and developing continuing education programs for pharmacy, nursing and other medical professionals.. ...
This Journal publishes original research work that contributes significantly to further the scientific knowledge in Pharma and Pharmaceutical Sciences (Pharmaceutical Technology, Pharmaceutical Analysis, Pharmacognosy, Pharmacology, Natural Product Research, Pharmaceutics, Novel Drug Delivery, Biopharmaceutics, Pharmacokinetics, Pharmaceutical / Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics, Pharmacoeconomics and Outcomes Research and Biotechnology of Pharmaceutical Interest) ...
The PharmaTutor Magazine is a monthly published online magazine, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences & Lifesciences (Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical / Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy and Phytochemistry, Pharmacology & toxicology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics, Biotechnology, Biochemistry, zoology, Microbiology). It is also deals with publishing interviews, government regulations and career related articles.
The effect of formulation on the penetration of coated and uncoated zinc oxide nanoparticles into the viable epidermis of human skin in vivo. Leite-Silva, Vania R., Le Lamer, Marina, Sanchez, Washington Y., Liu, David C., Sanchez, Washington H., Morrow, Isabel, Martin, Darren, Silva, Heron D. T., Prow, Tan L. W., Grice, Jeffrey E. and Roberts, Michael S. (2013) The effect of formulation on the penetration of coated and uncoated zinc oxide nanoparticles into the viable epidermis of human skin in vivo. European Journal of Pharmaceutics and Biopharmaceutics, 84 2: 297-308. doi:10.1016/j.ejpb.2013.01.020. ...
article{4338014, author = {Tavares da Silva, Ana and Burggraeve, Anneleen and Denon, Quenten and Van der Meeren, Paul and Sandler, Niklas and Van Den Kerkhof, Tom and Hellings, Mario and Vervaet, Chris and Remon, Jean Paul and Lopes, João Almeida and De Beer, Thomas}, issn = {0939-6411}, journal = {EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS}, keywords = {CHORD-LENGTH DISTRIBUTIONS,Spatial Filtering Velocirnetry,DROPLET SIZE ANALYSIS,BAYES THEOREM,LASER DIFFRACTION,MEASUREMENT FBRM,SOLUBILITY,PARAMETERS,VELOCITY,FBRM,Inline,In-process,PAT,Particle size,BEAM REFLECTANCE MEASUREMENT,Photometric Stereo Imaging,Eyecon (R),Laser diffraction,FLUID-BED GRANULATION}, language = {eng}, number = {3}, pages = {1006--1018}, title = {Particle sizing measurements in pharmaceutical applications : comparison of in-process methods versus off-line methods}, url = {http://dx.doi.org/10.1016/j.ejpb.2013.03.032}, volume = {85}, year = {2013 ...
The journal is devoted to the promotion of all fields of pharmaceutical sciences like Pharmaceutics and Industrial pharmacy, Medicinal Chemistry, Pharmacology and Toxicology, Phytopharmacy, Medicine, Clinical Pharmacy, Pharmacy Practice. Pharmaceutical Microbiolog and Biotechnolog, Biopharmaceutics, Pharmacokinetics and Pharmacodynamics, Computational Chemistry, Molecular modeling and Drug design, Pharmacoinformatics, Chemo informatics. It publishes research papers, short communications, dissertation abstracts and reviews, notes dealing with entire aspects of Medicine and pharmaceutical sciences. The ultimate vision of the journal is to become the premier source of high quality research from whole of the world. The aim of the journal is to increase the impact of research both in academia and industry, with strong emphasis on quality and originality.. ...
Duarte A. R. C., Ferreira A. S. D., Barreiros S., Cabrita E., Reis R. L., and Paiva A., A comparison between pure active pharmaceutical ingredients and therapeutic deep eutectic solvents: Solubility and permeability studies, European Journal Of Pharmaceutics And Biopharmaceutics, vol. 114, pp. 296-304, doi:10.1016/j.ejpb.2017.02.003, 2017. ...
Duarte A. R. C., Ferreira A. S. D., Barreiros S., Cabrita E., Reis R. L., and Paiva A., A comparison between pure active pharmaceutical ingredients and therapeutic deep eutectic solvents: Solubility and permeability studies, European Journal Of Pharmaceutics And Biopharmaceutics, vol. 114, pp. 296-304, doi:10.1016/j.ejpb.2017.02.003, 2017. ...
St. Louis College of Pharmacy (STLCOP). Dr. Salama focuses on pursuing translational (bench- to- bedside) research in the area of pharmacokinetics and applied biopharmaceutics. She examines factors that influence and improve drug delivery across biological membranes via modulation of drug transporters and the tight junctions. Dr. Salama has utilized diverse experimental techniques from the use of in vitro cell culture techniques (e.g. the use of recombinant cell lines), to preclinical animal models to clinical trials. Dr. Salamas current research projects study the pharmacokinetics and pharmacogenomics of the multidrug resistance protein, P-glycoprotein (P-gp) and the breast cancer resistance protein (BCRP) and evaluating disease associated changes in the overall activity of those drug transporters in special disease populations. The disease emphasis is geared primarily towards systemic inflammatory response (SIRS) and sepsis. In addition to her current research efforts in Critical Care, Dr. ...
Aim and Scope. International Journal of Farmacia (IJF) is a per-reviewed, online journal that publishes original research manuscripts, review articles in broad specializations of pharmacy. IJF maintains the quality by publishing research articles which have significance in different areas of pharmacy. IJF strives to manage high standards in peer reviewing, rapid publication. IJF concerned with different drug delivery systems, including their design and evaluation.. IJF covers the following areas of Pharmacy:. Pharmaceutics, Industrial Pharmacy, Biopharmaceutics, Pharmacokinetics, Nano-Technology Drug Delivery Systems, Pharmacology, Pharmacognosy, Pharmaceutical Analysis, Medicinal Chemistry, Pharmaceutical Management, Pharmacy practice, Bio-Technology and Natural Product Research.. ...
A First Course in Pharmacokinetics and Biopharmaceutics: The basics of kinetics. Starts with mathematical equations and relations and leads you to the related applications in medical and pharmaceutical applications.. ...
In this handy, pocket-size compilation of information about drug usage, the text is essentially in tabular form. Besides the usual tables on conversion factors, normal laboratory values, dialyzable drugs, and the potassium and sodium content of drugs and foods, this handbook provides lists of drug-induced diseases, pharmacogenetic abnormalities, and drug-drug interactions. The authors even attempt to categorize the clinical significance of the individual interactions.. A five-page course in the application of pharmaco-kinetics and biopharmaceutics to patient care is followed by information on dosage and contraindications of 190 widely used drugs. Although supplemented in a few instances with the plasma half-life, ...
Maniruzzaman, Mohammed, Ross, Steven A., Dey, Tumpa, Nair, Arun, Snowden, Martin J. and Douroumis, Dennis (2017) A quality by design (QbD) twin-screw extrusion wet granulation approach for processing water insoluble drugs. International Journal of Pharmaceutics, 526 (1-2). pp. 496-505. ISSN 0378-5173 (doi:10.1016/j.ijpharm.2017.05.020) Snowden, Martin J. (2016) Colloidal microgels - untapped potential? Journal of Nanomedicine and Nanotechnology, 7 (4). pp. 1-2. ISSN 2157-7439 (Online) (doi:10.4172/2157-7439.1000e142) Rudrangi, Shashi Ravi Suman, Kaialy, Waseem, Ghori, Muhammad U., Trivedi, Vivek, Alexander, Bruce David and Snowden, Martin J. (2016) Solid-state flurbiprofen and methyl-β-cyclodextrin inclusion complexes prepared using a single-step, organic solvent-free supercritical fluid process. European Journal of Pharmaceutics and Biopharmaceutics, 104. pp. 164-170. ISSN 0939-6411 (doi:10.1016/j.ejpb.2016.04.024) Ehiwe, Tracy O., Alexander, Bruce D, Mitchell, John C., Snowden, Martin J. and ...
The regulatory process established by the U.S. Food and Drug Administration (FDA) requires that each New Drug Applications (NDA) and Abbreviated New Drug Application (ANDA) includes the analytical procedures necessary to ensure the identity, strength, quality, purity and potency of the drug substance and drug product. [3][4] Furthermore, each Therapeutic Biologic Application (BLA) needs to include a full description of the manufacturing process. This includes analytical procedures that demonstrate that the manufactured product meets prescribed standards of identity, quality, safety, purity and potency. [5]. The analytical procedures and methods validation for drugs and biologics, Guidance for Industry, states that, over the life cycle of a medicinal product, new information (e.g., a better understanding of product characteristics) may warrant the development and validation of a new or alternative analytical method. [6]. But analytical methods should not be considered to be locked down or ...
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical drug substances derived from mammalian cell culture. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 27 years of experience producing monoclonal antibodies and recombinant proteins, Avids services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization. ...
3 Cases Substantially Completed, 4th Case Pending Completion, No Monetary Damages Contemplated. Bethesda, MD, October 24, 2017 - Northwest Biotherapeutics, Inc. (OTCQB: NWBO) (NW Bio), a U.S. biotechnology company developing DCVax® personalized immune therapies for operable and inoperable solid tumor cancers, is pleased to report meaningful progress in resolving four lawsuits that were brought against it as reported in the Companys periodic filings.. All four of the lawsuits have been or are being resolved without any negative findings against the Company or its management, despite allegations of misconduct and misrepresentation, and resolved without any monetary damages. One of the cases was dismissed outright, in its entirety, by the court. Two further cases were settled after NW Bio announced the Nasdaq remediation plan on September 6, 2016 and agreed to take certain future actions to enhance its corporate governance practices. The fourth case is in the process of being settled on similar ...
Chardan Capital analyst Geulah Livshits reiterated a Buy rating on Iovance Biotherapeutics (IOVA - Research Report) today and set a price target of $36.00. The companys shares closed last Monday at $30.68, close to its 52-week high of $34.46.. According to TipRanks.com, Livshits is a 4-star analyst with an average return of 8.6% and a 46.4% success rate. Livshits covers the Healthcare sector, focusing on stocks such as Rocket Pharmaceuticals, Crispr Therapeutics AG, and Intellia Therapeutics.. Iovance Biotherapeutics has an analyst consensus of Strong Buy, with a price target consensus of $37.17, which is a 19.8% upside from current levels. In a report released yesterday, Piper Sandler also maintained a Buy rating on the stock with a $40.00 price target.. See todays analyst top recommended stocks ,,. Based on Iovance Biotherapeutics latest earnings release for the quarter ending December 31, the company reported a quarterly GAAP net loss of $63.57 million. In comparison, last year the company ...
BETHESDA, MD, January 18, 2017 - Northwest Biotherapeutics, Inc. (OTCQB: NWBO) (NW Bio), a U.S. biotechnology company developing DCVax® personalized immune therapies for operable and inoperable solid tumor cancers, announced today that Dr. Marnix Bosch, Chief Technical Officer of NW Bio, will present at the Phacilitate Immunotherapy World Conference on Thursday, January 19, 2017, at the Hyatt Regency Hotel in Miami, Florida.. Dr. Bosch will chair the session entitled New Therapeutic Approaches - Expanding the Reach of Cancer Immunotherapy to All Patients In Need of Better Treatments, taking place from 4:30 p.m. to 5:35 p.m. on Thursday, January 19, and will make a presentation on the same subject. There will not be a webcast. The presentation was originally scheduled to be made by Ms. Linda Powers, CEO of NW Bio, but she was unable to do so due to illness.. The annual Phacilitate Immunotherapy World Forum is one of the worlds largest and fastest growing senior-level immuno-oncology ...
Global Biotherapeutics Cell Line Development Market is registering a CAGR of 7.50% from 2015 to 2022, the global biotherapeutics cell line development market is anticipated to reach a value of US$100 mn by 2022.
ROCKVILLE, Md., Sept. 4, 2019 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (the Company or RegeneRx), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that J.J. Finkelstein, President and Chief Executive Officer, will present a corporate update at The Fall Investor Summit on September 16-17, 2019, in New York City. The specific presentation date, time and webcast information will be announced as soon as determined by the conference schedulers. The Company will not be presenting at the Rodman & Renshaw Investment Conference on September 8-10 as was previously announced.. About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com) RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac ...
Novartis is expanding its already ambitious investment program in Singapore. In tandem with the opening of a new pharmaceutical tableting facility there last week, the Swiss drug giant revealed plans to spend $700 million on a biopharmaceuticals plant making clinical and commercial quantities of monoclonal antibodies. Construction on the cell-culture plant, its biggest to date, will begin early next year and should be complete by late 2012, creating 300 new jobs. Once operational, the plant will support Novartis pipeline of biologics, which now represent 25% of its overall drugs in development. Novartis first big push into Singapore was in 2001 with the opening of a research center focused on discovering small molecules to treat tropical diseases. The tableting plant will make existing Novartis drugs, such as Diovan and Tekturna, for the U.S. and Japanese markets. Novartis joins a growing list of companies situating their new biopharmaceuticals plants in Singapore. In the past two years, ...
Target. NGM120 is a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling for the potential treatment of cancer and cancer anorexia/cachexia syndrome (CACS).. NGMs preclinical research suggests the central role of the GDF15/GFRAL pathway in promoting tumor-associated appetite suppression and weight loss. In addition, GDF15 levels are elevated in numerous tumor types and, based on available scientific literature, increased serum GDF15 levels are associated with worse prognosis in prostate, colorectal, esophageal and ovarian cancers. In preclinical studies of NGM120, our team has demonstrated that blocking the interaction between GFRAL and GDF15 is able to both reduce tumor-associated weight loss and slow tumor growth and could potentially provide a novel treatment for CACS and cancer.. Clinical Development Status. In February 2020, we announced the initiation of a Phase ...
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Biopharmaceutics & Drug Disposition. 19 (5): 309-14. doi:10.1002/(SICI)1099-081X(199807)19:5. 3.0.CO;2-9. PMID 9673783. ...
Biopharmaceutics & Drug Disposition. 13 (4): 255-62. doi:10.1002/bdd.2510130404. PMID 1600111. S2CID 72293850. Klooker, T. K.; ...
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  • Ernst Moritz Arndt University Greifswald, Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Felix-Hausdorff-Strasse 3, 17489 Greifswald, Germany. (nih.gov)
  • In 1986 he attended as a visiting researcher the School of Pharmacy of the University of California, San Francisco (UCSF) and in the same year he joined the University of Milan, where he is presently Full Professor of Pharmaceutical Technology and Biopharmaceutics. (unimi.it)
  • The Institute of Pharmacy was established in 2017 and is composed of the following departments: Clinical Pharmacy, Pharmaceutical Biology, Pharmaceutical and Medical Chemistry as well as the department for Pharmaceutical Technology and Biopharmaceutics which will be established in the coming year. (pmu.ac.at)
  • The Department of Pharmaceutical Technology and Biopharmaceutics will focus on drug delivery and drug targeting, new carrier systems and materials, tissue engineering as well as pharmacokinetic and prediction models. (pmu.ac.at)
  • Clinical Pharmacology & Biopharmaceutics (CPB) provides the quarterly publication of articles in all areas related to Pharmacology , Clinical pharmacokinetics Clinical pharmacology studies, drug interactions, Applied biopharmaceutics . (omicsonline.org)
  • Clinical Pharmacology & Biopharmaceutics Journals welcomes the submission of manuscripts that meet the general criteria of significance and scientific excellence. (omicsonline.org)
  • Clinical Pharmacology & Biopharmaceutics Journal follows a progressive editorial policy that encourages researchers to submit the original research, reviews and editorial observations as articles, well supported by tables and graphic representation. (omicsonline.org)
  • Clinical Pharmacology & Biopharmaceutics, a self supporting Journal and does not receive funding from any institution/government. (omicsonline.org)
  • Being an Open Access Journal, Journal of Clinical Pharmacology & Biopharmaceutics does not receive payment for subscription, as the articles are freely accessible over the internet. (omicsonline.org)
  • aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of Advanced Biopharmaceutics and Serotonin Pharmacology. (waset.org)
  • Also, high quality research contributions describing original and unpublished results of conceptual, constructive, empirical, experimental, or theoretical work in all areas of Advanced Biopharmaceutics and Serotonin Pharmacology are cordially invited for presentation at the conference. (waset.org)
  • ICABSP 2022 has teamed up with the Special Journal Issue on Advanced Biopharmaceutics and Serotonin Pharmacology . (waset.org)
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  • We conclude by suggesting that a Biopharmaceutics Drug Disposition Classification System (BDDCS) using elimination criteria may expand the number of Class 1 drugs eligible for a waiver of in vivo bioequivalence studies and provide predictability of drug disposition profiles for Classes 2, 3, and 4 compounds. (nih.gov)
  • Given this information, 11 different data sets using human microsomes and hepatocytes were evaluated to search for trends in accuracy, extent of protein binding, and drug classification based on the Biopharmaceutics Drug Disposition Classification System (BDDCS), which makes predictions about transporter effects. (aspetjournals.org)
  • The Biopharmaceutics Drug Disposition Classification System (BDDCS), which categorizes transporter effects on drug disposition, says class 1 compounds exhibit minimal clinically relevant transporter effects, whereas class 2 compounds may be governed by transporter effects in the gut and liver ( Wu and Benet, 2005 ). (aspetjournals.org)
  • ADME Processes and Pharmaceutical Sciences is written as a core textbook for ADME processes, pharmacy, pharmacokinetics, drug delivery, biopharmaceutics, drug disposition, drug design and medicinal chemistry courses. (springer.com)
  • Use of the Biopharmaceutics Drug Disposition Classification System (BDDCS) to Help Predict the Occurrence of Idiosyncratic Cutaneous Adverse Drug R. (cdc.gov)
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  • The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. (wikipedia.org)
  • Biopharmaceutics Classification System (BCS): Development, Implementation, and Growth. (wikipedia.org)
  • The Biopharmaceutics Classification System (BCS) was developed to allow prediction of in vivo pharmacokinetic performance of drug products from measurements of permeability (determined as the extent of oral absorption) and solubility. (nih.gov)
  • Effective 25 May 2021 the ICH guideline M9 "Biopharmaceutics Classification System-Based Biowaivers" is implemented by PQT/MED. (who.int)
  • This guideline provides an internationally harmonised approach for the classification of active pharmaceutical ingredients (APIs) within the Biopharmaceutics Classification System (BCS) and for BCS-based biowaivers from the requirement to conduct in vivo bioequivalence studies for drug products. (who.int)
  • Biopharmaceutics Classification System (BCS) is an important tool which uses in vitro results for comparison with bioavailability in vivo (biowaiver). (eurekaselect.com)
  • Objective: This work proposes the study of valsartan biopharmaceutics properties and its BCS classification. (eurekaselect.com)
  • It is important to emphasize that the conditions considered here are indicated to define the biopharmaceutics classification by regulatory agencies. (eurekaselect.com)
  • Salva Salva Biopharmaceutics Classification System-The Scienti. (scribd.com)
  • The biopharmaceutics classification system( BCS) is a scientific framework or method for classifying drugs based on drug solubility and permeability,which can be used to provide drug bioavailability-absorption correlation analysis. (bvsalud.org)
  • Based on the characteristics of multi-component and multi-target of traditional Chinese medicine( TCM) as well as the concept,method and technology of BCS,the research group proposed biopharmaceutics classification system of Chinese materia medica( CMMBCS) and carried out research and data accumulation of classical prescriptions. (bvsalud.org)
  • Drugs which meet a certain Biopharmaceutics Classification System criteria may be exempt from these expensive tests and may be permitted a biowaiver (2). (ukessays.com)
  • Leon Shargel, PhD is vice president of biopharmaceutics at Eon Labs, Inc. Wilson, NC. (ecampus.com)
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  • Biopharmaceutics can be defined as the study of the physical and chemical properties of drugs and their proper dosage as related to the onset, duration, and intensity of drug action, or it can be defined as the study of the effects of physicochemical properties of the drug and the drug product, in vitro , on the bioavailability of the drug, in vivo , to produce a desired therapeutic effect. (mhmedical.com)
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  • Global Summit on Biopharma and Biotherapeutics will focus on many interesting scientific sessions and covers all frontier topics in Biopharmaceuticals which includes Challenges in Biopharmaceutics, Biopharmaceutical Drug Discovery & Development, Clinical Trials in Biopharmaceutics, BA/BE Studies, Biosimilars & Biologics Drugs, and many more. (alliedacademies.com)
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  • Biopharmaceutics explore the interrelationship of the physical/chemical properties of the drug, the dosage form (drug product) in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption and the use of this information to optimise the therapeutic efficacy of the drug products. (alliedacademies.com)
  • Couragen Biopharmaceutics, LLC is a North Carolina startup biotechnology company whose mission is to develop gene therapy and protein therapy products for pre-clinical and clinical use. (rtp.org)
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