Biopharmaceutics
Therapeutic Equivalency
Pharmaceutical Preparations
Pharmacokinetics
Biological Availability
Solubility
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)Biopharmaceutics is a branch of pharmaceutical sciences that deals with the study of the properties of biological, biochemical, and physicochemical systems and their interactions with drug formulations and delivery systems. It encompasses the investigation of the absorption, distribution, metabolism, and excretion (ADME) of drugs in biological systems, as well as the factors that affect these processes.
The main goal of biopharmaceutics is to understand how the physical and chemical properties of a drug and its formulation influence its pharmacokinetics and pharmacodynamics, with the aim of optimizing drug delivery and improving therapeutic outcomes. Biopharmaceutical studies are essential for the development and optimization of new drugs, as well as for the improvement of existing drug products.
Some key areas of study in biopharmaceutics include:
1. Drug solubility and dissolution: The ability of a drug to dissolve in biological fluids is critical for its absorption and bioavailability. Biopharmaceutical studies investigate the factors that affect drug solubility, such as pH, ionic strength, and the presence of other molecules, and use this information to optimize drug formulations.
2. Drug permeability: The ability of a drug to cross biological membranes is another key factor in its absorption and bioavailability. Biopharmaceutical studies investigate the mechanisms of drug transport across cell membranes, including passive diffusion, active transport, and endocytosis, and use this information to design drugs and formulations that can effectively penetrate target tissues.
3. Drug metabolism: The metabolic fate of a drug in the body is an important consideration for its safety and efficacy. Biopharmaceutical studies investigate the enzymes and pathways involved in drug metabolism, as well as the factors that affect these processes, such as genetic polymorphisms, age, sex, and disease state.
4. Drug interactions: The interaction between drugs and biological systems can lead to unexpected effects, both beneficial and harmful. Biopharmaceutical studies investigate the mechanisms of drug-drug and drug-biological interactions, and use this information to design drugs and formulations that minimize these risks.
5. Pharmacokinetics and pharmacodynamics: The study of how a drug is absorbed, distributed, metabolized, and excreted (pharmacokinetics) and how it interacts with its target receptors or enzymes to produce its effects (pharmacodynamics) is an essential component of biopharmaceutical research. Biopharmaceutical studies use a variety of techniques, including in vitro assays, animal models, and clinical trials, to characterize the pharmacokinetics and pharmacodynamics of drugs and formulations.
Overall, biopharmaceutical research is an interdisciplinary field that combines principles from chemistry, biology, physics, mathematics, and engineering to develop new drugs and therapies. By understanding the complex interactions between drugs and biological systems, biopharmaceutical researchers can design more effective and safer treatments for a wide range of diseases and conditions.
Therapeutic equivalence refers to the concept in pharmaceutical medicine where two or more medications are considered to be equivalent in clinical efficacy and safety profiles. This means that they can be used interchangeably to produce the same therapeutic effect.
Two products are deemed therapeutically equivalent if they contain the same active ingredient(s), are available in the same dosage form and strength, and have been shown to have comparable bioavailability, which is a measure of how much and how quickly a drug becomes available for use in the body.
It's important to note that therapeutic equivalence does not necessarily mean that the medications are identical or have identical excipients (inactive ingredients). Therefore, patients who may have sensitivities or allergies to certain excipients should still consult their healthcare provider before switching between therapeutically equivalent medications.
In many countries, including the United States, the Food and Drug Administration (FDA) maintains a list of therapeutic equivalence evaluations for generic drugs, known as the "Orange Book." This resource helps healthcare providers and patients make informed decisions about using different versions of the same medication.
Pharmaceutical preparations refer to the various forms of medicines that are produced by pharmaceutical companies, which are intended for therapeutic or prophylactic use. These preparations consist of an active ingredient (the drug) combined with excipients (inactive ingredients) in a specific formulation and dosage form.
The active ingredient is the substance that has a therapeutic effect on the body, while the excipients are added to improve the stability, palatability, bioavailability, or administration of the drug. Examples of pharmaceutical preparations include tablets, capsules, solutions, suspensions, emulsions, ointments, creams, and injections.
The production of pharmaceutical preparations involves a series of steps that ensure the quality, safety, and efficacy of the final product. These steps include the selection and testing of raw materials, formulation development, manufacturing, packaging, labeling, and storage. Each step is governed by strict regulations and guidelines to ensure that the final product meets the required standards for use in medical practice.
Pharmacokinetics is the branch of pharmacology that deals with the movement of a drug in the body after administration. It involves the processes of absorption, distribution, metabolism, and excretion (ADME) of drugs.
1. Absorption: This is the process by which a drug is taken into the body and made available for distribution to the site of action.
2. Distribution: This refers to the dispersion of the drug throughout the body after absorption. It involves the transfer of the drug from the bloodstream into various tissues and organs.
3. Metabolism: This is the biotransformation of a drug by enzymes, usually in the liver, into metabolic products (also known as metabolites). These metabolites may be pharmacologically active, inactive, or toxic.
4. Excretion: This is the process by which drugs and their metabolites are eliminated from the body, typically through the kidneys (urine), lungs (exhaled air), skin (sweat), or gastrointestinal tract (feces).
Understanding pharmacokinetics is crucial for determining the optimal dosage regimen of a drug to achieve and maintain its therapeutic concentration in the body while minimizing potential side effects.
Biological availability is a term used in pharmacology and toxicology that refers to the degree and rate at which a drug or other substance is absorbed into the bloodstream and becomes available at the site of action in the body. It is a measure of the amount of the substance that reaches the systemic circulation unchanged, after administration by any route (such as oral, intravenous, etc.).
The biological availability (F) of a drug can be calculated using the area under the curve (AUC) of the plasma concentration-time profile after extravascular and intravenous dosing, according to the following formula:
F = (AUCex/AUCiv) x (Doseiv/Doseex)
where AUCex is the AUC after extravascular dosing, AUCiv is the AUC after intravenous dosing, Doseiv is the intravenous dose, and Doseex is the extravascular dose.
Biological availability is an important consideration in drug development and therapy, as it can affect the drug's efficacy, safety, and dosage regimen. Drugs with low biological availability may require higher doses to achieve the desired therapeutic effect, while drugs with high biological availability may have a more rapid onset of action and require lower doses to avoid toxicity.
Solubility is a fundamental concept in pharmaceutical sciences and medicine, which refers to the maximum amount of a substance (solute) that can be dissolved in a given quantity of solvent (usually water) at a specific temperature and pressure. Solubility is typically expressed as mass of solute per volume or mass of solvent (e.g., grams per liter, milligrams per milliliter). The process of dissolving a solute in a solvent results in a homogeneous solution where the solute particles are dispersed uniformly throughout the solvent.
Understanding the solubility of drugs is crucial for their formulation, administration, and therapeutic effectiveness. Drugs with low solubility may not dissolve sufficiently to produce the desired pharmacological effect, while those with high solubility might lead to rapid absorption and short duration of action. Therefore, optimizing drug solubility through various techniques like particle size reduction, salt formation, or solubilization is an essential aspect of drug development and delivery.
Pharmaceutical chemistry is a branch of chemistry that deals with the design, synthesis, and development of chemical entities used as medications. It involves the study of drugs' physical, chemical, and biological properties, as well as their interactions with living organisms. This field also encompasses understanding the absorption, distribution, metabolism, and excretion (ADME) of drugs in the body, which are critical factors in drug design and development. Pharmaceutical chemists often work closely with biologists, medical professionals, and engineers to develop new medications and improve existing ones.
Biopharmaceutics Classification System
European Journal of Pharmaceutics and Biopharmaceutics
Drug accumulation ratio
Praziquantel
Doxylamine
Fexofenadine
Chemistry of ascorbic acid
Iprindole
Sulfadimidine
Modified-release dosage
Rilmazafone
Naringenin
Plasma protein binding
Safinamide
Tramadol
Traditional African medicine
Dimenhydrinate
Deramciclane
Dinalbuphine sebacate
Benzydamine
Butyrylcholinesterase
Ketotifen
Levamisole
Methylphenidate
SLC22A8
Metazosin
Delorazepam
Repinotan
Epristeride
TS-121
Biopharmaceutics Classification System - Wikipedia
Guidelines about Clinical Pharmacology and Biopharmaceutics
11th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology | Capsugel
Biopharmaceutics risk assessment via gastrointestinal modelling | Webinars | Events | Siemens Process Systems Engineering
A Mechanistic Physiologically-Based Biopharmaceutics Modeling Approach to Assess the In Vivo Performance of an Orally...
Caco-2 cells and Biopharmaceutics Classification System (BCS) for prediction of transepithelial transport of xenobiotics (model...
Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-Space for...
Experimental Biopharmaceutics And Pharmacokinetics - BookGanga.com
Biopharmaceutics Review Articles | Medical Journals | 52738
Health Occupations - Biopharmaceutics | CU Experts | CU Boulder
Scienxt Journal of Biopharmaceutics and Pharmacokinetics(SJBP) - Scienxt
Details for: Applied biopharmaceutics and pharmacokinetics / › WHO HQ Library catalog
Dr. Carsten Ehrhardt - Professor in Pharmaceutics and Biopharmaceutics - Trinity College Dublin
Details for: Biopharmaceutics and clinical pharmacokinetics : › Dr. S. R. Lasker Library catalog
Abstracts - FIP - International Pharmaceutical Federation
Glossary | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
Bio-Pharmaceutical Sciences: Drug Delivery Technology and Biopharmaceutics (Master 2010-2011) - Prospectus - Universiteit Leiden
Guidances | Drugs | FDA
Applied Biopharmaceutics & Pharmacokinetics / 9th ed.
Artificial neural networks as universal modeling tools in pharmaceutical technology and biopharmaceutics - Digital Medical...
Pharmacy Technician Course | Towson University
Pharmaceutical Sciences (BSC HONS) B210 | Courses | Queen's University Belfast
Enzyme kinetics - Wikipedia
Physiological Based Pharmacokinetic and Biopharmaceutics Modelling of Subcutaneously Administered Compounds - An Overview of In...
The EPA National Library Catalog | EPA National Library Network | US EPA
Drug Approval Package: Prepopik NDA 202535
Engagement and Outreach - Arnold School of Public Health | University of South Carolina
Kervin Evans : USDA ARS
Pharmacokinetics6
- SJCN- Scienxt Journal of Biopharmaceutics and Pharmacokinetics, Double blind peer-reviewed Journal, disseminates the most recent findings and innovations in various fields of Biopharmaceutics and Pharmacokinetics in the form of Original Research, Reviews, Case Studies, Opinions, etc. (scienxt.com)
- This course presents the basic concepts and principles of biopharmaceutics and pharmacokinetics. (thetowertech.com)
- To apply knowledge of biopharmaceutics and pharmacokinetics in in-vitro in-vivo correlation (IVIVC), product development and clinical settings. (thetowertech.com)
- Applied biopharmaceutics and pharmacokinetics / Leon Shargel, Andrew Yu. (who.int)
- UVAS Library catalog › Details for: Applied Biopharmaceutics & Pharmacokinetics / 9th ed. (edu.pk)
- Applied Biopharmaceutics & Pharmacokinetics / 9th ed. (edu.pk)
European Journal of Pharmaceutics and Biopharmaceutics2
- Carsten actively serves on the Editorial Boards of the American Journal of Physiology - Lung Cellular and Molecular Physiology, European Journal of Pharmaceutics and Biopharmaceutics, European Journal of Pharmaceuticals Sciences, Journal of Aerosol Medicine and Pulmonary Drug Delivery and Journal of Pharmaceutical Sciences. (qepler.com)
- European Journal of Pharmaceutics and Biopharmaceutics , 187. (tu-braunschweig.de)
Pharmaceutics2
- The 11th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology addresses the entire spectrum of topics, ranging from engineering aspects during the manufacturing process, to cutting-edge characterization techniques as well as potential pitfalls and hurdles to be overcome during product development, manufacturing and characterization. (capsugel.com)
- Biopharmaceutics, drug delivery and clinical pharmaceutics to undergraduate and postgraduate students. (otago.ac.nz)
Physiologically-based biopharmaceutics2
- Establishing the link between biopredictive in vitro dissolution testing and mechanistic oral absorption modeling (i.e., physiologically-based biopharmaceutics modeling (PBBM)) creates an opportunity to potentially request biowaivers in the near future for orally administered drug products, regardless of its classification according to the Biopharmaceutics Classification System (BCS). (lonza.com)
- A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor. (simulations-plus.com)
Saarland University1
- Carsten obtained his Ph.D. in Biopharmaceutics from Saarland University in 2003. (qepler.com)
Pharmacodynamics1
- Department of Biopharmaceutics and Pharmacodynamics, Medical University of Gdansk, Al. (bvsalud.org)
Classification5
- The Biopharmaceutics Classification System is a system to differentiate drugs on the basis of their solubility and permeability. (wikipedia.org)
- Biopharmaceutics Classification System (BCS): Development, Implementation, and Growth. (wikipedia.org)
- Caco-2 cells and Biopharmaceutics Classification System (BCS) for prediction of transepithelial transport of xenobiotics (model drug: caffeine). (nel.edu)
- Caffeine was chosen as a model drug and is supposed to be class I of the Biopharmaceutics Classification System (BCS). (nel.edu)
- Smetanova I, Stetinova E, Kholova A, Kvetina A, Smetana A, Svoboda B, Caco-2 cells and Biopharmaceutics Classification System (BCS) for prediction of transepithelial transport of xenobiotics (model drug: caffeine). (nel.edu)
Drug products1
- The biopharmaceutics performance of drug products can depend on multiple factors, including drug substance physicochemical properties, particle size distribution, patient physiology and dosage form composition. (psenterprise.com)
Performance2
- This showed significantly different biopharmaceutics performance when compared to simulations using static physiological parameters. (psenterprise.com)
- Des échantillons de sang ont été prélevés pendant les 24 heures suivant l'administration de la dose et la concentration en aténolol a été évaluée par chromatographie en phase liquide à haute performance. (who.int)
Pharmaceutics and biopharmaceutics1
- Fraunhofer W and Winter G. European Journal of Pharmaceutics and Biopharmaceutics, 58: 369-383, 2004. (nih.gov)
Classification System2
- The Biopharmaceutics Classification System is a system to differentiate drugs on the basis of their solubility and permeability. (wikipedia.org)
- Biopharmaceutics Classification System (BCS): Development, Implementation, and Growth. (wikipedia.org)
20221
- The Biopharmaceutics Focus Group of the Academy of Pharmaceutical Sciences (APS) of Great Britain presented a workshop on nasal biopharmaceutics at the 2022 Drug Delivery to the Lungs Conference (DDL2022) in December 2022 in Edinburgh, UK. (inhalationmag.com)
Drugs1
- Simcyp Biopharmaceutics software facilitates developing these drugs, which constitute 90% of new drug candidates. (fox8.com)
Principles1
- The objective of this course is to explain basic concepts and principles of biopharmaceutics and pharmacokinetic parameters for oral and parenteral compartment models. (jinnah.edu)
Significance1
- In the realm of medication advancement, the significance of the expression 'biopharmaceutics' frequently brings out disarray, even among researchers and experts who work in the field. (tsijournals.com)
Clinical1
- Simcyp Biopharmaceutics software also helps sponsors develop the evidence needed to attain biowaivers which are used in lieu of conducting clinical studies. (fox8.com)
Products1
- The speakers summarized how biopharmaceutics and performance of nasal products are currently evaluated and shared their thoughts on new developments and unmet needs. (inhalationmag.com)
Knowledge1
- To apply knowledge of biopharmaceutics in different compartmental models and multiple dosing regimen. (jinnah.edu)
Group1
- Biopharmaceutics Working Group. (nih.gov)
Research1
- Inhalation MagazineBack page: Research focus on nasal biopharmaceutics. (inhalationmag.com)