Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.
Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

Bacteriologic cure of experimental Pseudomonas keratitis. (1/1937)

Two long-term therapy trials with high concentrations of antibiotic were carried out to determine the duration of therapy required to achieve bacteriologic cure of experimental Pseudomonas keratitis in guinea pigs. In the first study, corneas still contained Pseudomonas after 4 days of continual topical therapy with either tobramycin 400 mg/ml, amikacin 250 mg/ml, ticarcillin 400 mg/ml, or carbenicillin 400 mg/ml. In an 11-day trial of topical therapy with tobramycin 20 mg/ml, 34 of 36 corneas grew no Pseudomonas after 6 or more days of therapy. The bacteriologic response to therapy in this model occurred in two phases. About 99.9% or more of the organisms in the cornea were killed in the first 24 hr of therapy. The numbers of bacteria remaining in the cornea declined gradually over the next several days until the corneas were sterile. Optimal antibiotic therapy may include two stages: initial intensive therapy with high concentrations of antibiotic applied frequently to achieve a large rapid decrease in numbers of organisms in the cornea, followed by prolonged, less intensive therapy to eradicate organisms and prevent relapse.  (+info)

A tale of two (or more) cities: geographic transferability of pharmacoeconomic data. (2/1937)

The economic evaluation of a new medicine often must be based on data gathered in multiple countries. Because replication of trials is an expensive and inefficient undertaking, analysts need to determine the validity of transferring cost-effectiveness data from one country to another. Threats to transferring data involve differences among countries with regard to demography and epidemiology of disease, clinical practice and conventions, incentives to and regulation of healthcare providers, relative price levels, consumer preferences, and opportunity cost of resources. Because of these differences, a drug can be cost-effective in one country and not cost-effective in another. Adapting a cost-effectiveness study conducted in one country to another country requires careful scrutiny of the relevance of comparators, practice patterns, and relative price weights.  (+info)

Use of an intravenous contrast agent (Optison) to enhance echocardiography: efficacy and cost implications. Optison Multicenter Study Group. (3/1937)

OBJECTIVE: To compare the overall diagnostic costs associated with non-contrast and contrast echocardiography. STUDY DESIGN: Phase III clinical trial. PATIENTS AND METHODS: In a secondary analysis of data from a phase III clinical trial of the intravenous contrast agent Optison, we compared the costs associated with obtaining a diagnosis in 203 patients who underwent non-contrast and contrast echocardiography. Costs for the initial test and any follow-up tests were derived from adjusted Medicare charges and a transition-1 microcost accounting system. RESULTS: Diagnostic yield from echocardiograms was 87% with the use of Optison (3 mL) and 49% when no contrast agent was used (P < 0.001). Because technically inadequate echocardiograms were more common in the non-contrast group, follow-up testing was recommended for 42% of patients in this group compared with 12% of those who had undergone a contrast-enhanced echocardiogram (P < 0.001). Although use of Optison increased the initial diagnostic cost by $125, overall costs were 17% lower when Optison was used (P < 0.0001). Use of Optison also resulted in a 17% to 70% decrease in confirmatory transesophageal echocardiography, catheterization, and nuclear studies. Optison improved diagnostic accuracy by 2.7-fold in patients with an initial non-diagnostic echocardiogram, resulting in a substantial cost savings of $269 per patient.  (+info)

Clinical trial experience by simulation: a workshop report. (4/1937)

A new computer program for experimental design simulation was used in a three-day postgraduate workshop on clinical trials. Participants were given information on a fictitious new drug and asked to design a trial to evaluate it. On the first day they reviewed the data and designed a protocol, and results for these specifications were generated on the computer. The second day was spent analysing results, and on the last day the findings of the different studies were presented at a symposium. Flexibility of the program ensured a high degree of realism in all trials and emphasised the influence of design on results and conclusions.  (+info)

Research strategies for behavioral teratology studies. (5/1937)

Several compelling aruguments have been advanced in support of expanding the use of "behavioral teratology" evaluations as routine components of toxicologic screening procedures. As a basis for development of effective behavioral teratology screening approaches, a conceptual framework is presented which interrelates: (1) changes in relative functional brain capacity with age, (2) possible times and durations of exposures to environmental insults, and (3) various types of toxicity testing procedures carried out at appropriate time points in relation to different exposure period. Within the context, several research strategies for behavioral teratology studies are concisely posed and evaluated. These include: (1) clinical hypothesis testing, where particular effect(s) of a given agent are evaluated based on hypotheses derived from clinical or epidemiological observations; (2) comprehensive screening approaches, where multifaceted, long-term longitudinal neurobehavioral evaluations are employed to assess whether any of a large number of possible deletarious effects are exerted by an agent and at what threshold exposure levels; (3) alternative screening heuristics, by which adequate assessments of neurobehavioral toxicity of various agents may be accomplished without completion of more exhaustive, but also more expensive and time-consuming comprehensive screening protocols.  (+info)

Randomized double-blind placebo-controlled trial of homoeopathic 'proving' for Belladonna C30. (6/1937)

Homoeopathic drug pictures are developed by recording the symptomatic effects of homoeopathic remedies given to healthy volunteers (a 'proving'). In a double-blind randomized controlled trial we tested the hypothesis that individuals using an infinitesimal dilution of Belladonna (thirtieth potency, C30) would record more true symptoms, on a questionnaire that contained both true and false Belladonna proving symptoms, than those receiving placebo. 60 volunteers entered the study and 47 completed data collection. We were unable to distinguish between Belladonna C30 and placebo using our primary outcome measure. For the secondary outcome measure we analysed the number of individuals who proved to the remedy according to our predefined criteria: 4 out of 19 proved in the Belladonna C30 group and 1 out of 27 in the placebo group (difference not statistically significant). This pilot study does not demonstrate a clear proving reaction for Belladonna C30 versus placebo, but indicates how the question might be further investigated.  (+info)

Cutaneously applied 4-hydroxytamoxifen is not carcinogenic in female rats. (7/1937)

Tamoxifen is widely used to treat oestrogen-dependent carcinoma of the breast. Previous long-term studies have shown that oral administration of tamoxifen induces hepatoproliferative lesions and hepatocellular tumours in rats. 4-hydroxytamoxifen is an active metabolite of tamoxifen undergoing clinical evaluation for the treatment of various non-malignant breast diseases by topical application. In the present study, 4-hydroxytamoxifen was administered daily by cutaneous application for 101 weeks to groups of 50 female Sprague-Dawley rats at 20, 140 or 1000 microg/kg/day. The product was applied with no occlusive bandage and oral ingestion was avoided by application of an Elizabethan collar for 6 h after administration. Treatment with 4-hydroxytamoxifen was clinically well tolerated and induced changes such as decreased food consumption and body weight gain, uterine and ovarian atrophy, mucification of vaginal epithelium and reduced mammary development, all of which were attributed to its pharmacological action. Mortality was significantly lower in the treated animals. The number of animals with palpable masses was similarly reduced. The incidence of mammary tumours and hypophyseal tumours was markedly lower in 4-hydroxytamoxifen-treated animals. The incidence of chronic tubulo-interstitial nephropathies, a common cause of mortality, was also lowered. There was no evidence of a carcinogenic action of 4-hydroxytamoxifen on the liver, genital organs or skin. Plasma levels of 4-hydroxytamoxifen were stable over the duration of the study and were proportional to the administered dose, exceeding clinical plasma levels by 60-fold at the high dose-level. In conclusion, 4-hydroxytamoxifen is not carcinogenic in the rat and reduces the incidence of spontaneous mammary and hypophyseal tumours.  (+info)

Evaluation of the renal effects of an antisense phosphorothioate oligodeoxynucleotide in monkeys. (8/1937)

Antisense phosphorothioate oligodeoxynucleotides are therapeutic agents that provide target specificity resulting from Watson-Crick base pairing. However, there are nonspecific effects that in some instances result in toxicity. These compounds accumulate in the kidney and induce renal proximal tubular degeneration at high doses. The relationship between accumulation of phosphorothioate oligodeoxynucleotides in the kidney, indicators of renal toxicity, and histomorphology were investigated in rhesus monkeys. Monkeys received vehicle or an escalating dose regimen of 3, 10, 40, and 80 mg/kg of ISIS 2105 and were then evaluated for changes in clinical pathology indices, urinalysis parameters, and renal histopathology. Urinalysis revealed an increase in protein levels and a slight increase in blood content following the third 40 mg/kg dose and continuing through the 80 mg/kg doses, whereas other urinary markers of renal toxicity were unchanged. Creatinine clearance was slightly decreased in monkeys during the 80 mg/kg dose cycle. Granulation in the cytoplasm of proximal tubular epithelial cells was evident by microscopic examination of kidney and was present at all doses examined and increased with dose. Immunohistochemical staining localized the oligodeoxynucleotide within these granules. Histopathologic changes consisting of minimal to moderate tubular degeneration were present only at the higher doses of 40 and 80 mg/kg and at high tissue concentrations, and these changes occurred concurrent with functional alterations, whereas lower doses (< or = 10 mg/kg) did not affect a pathologic or functional change.  (+info)

"Drug evaluation" is a medical term that refers to the systematic process of assessing the pharmacological, therapeutic, and safety profile of a drug or medication. This process typically involves several stages, including preclinical testing in the laboratory, clinical trials in human subjects, and post-marketing surveillance.

The goal of drug evaluation is to determine the efficacy, safety, and optimal dosage range of a drug, as well as any potential interactions with other medications or medical conditions. The evaluation process also includes an assessment of the drug's pharmacokinetics, or how it is absorbed, distributed, metabolized, and eliminated by the body.

The findings from drug evaluations are used to inform regulatory decisions about whether a drug should be approved for use in clinical practice, as well as to provide guidance to healthcare providers about how to use the drug safely and effectively.

Preclinical drug evaluation refers to a series of laboratory tests and studies conducted to determine the safety and effectiveness of a new drug before it is tested in humans. These studies typically involve experiments on cells and animals to evaluate the pharmacological properties, toxicity, and potential interactions with other substances. The goal of preclinical evaluation is to establish a reasonable level of safety and understanding of how the drug works, which helps inform the design and conduct of subsequent clinical trials in humans. It's important to note that while preclinical studies provide valuable information, they may not always predict how a drug will behave in human subjects.

"Drug approval" is the process by which a regulatory agency, such as the US Food and Drug Administration (FDA), grants formal authorization for a pharmaceutical company to market and sell a drug for a specific medical condition. The approval process is based on rigorous evaluation of clinical trial data to ensure that the drug is safe and effective for its intended use.

The FDA's approval process typically involves several stages, including preclinical testing in the lab and animal studies, followed by three phases of clinical trials in human subjects. The first phase tests the safety of the drug in a small group of healthy volunteers, while the second and third phases test the drug's efficacy and side effects in larger groups of patients with the medical condition for which the drug is intended.

If the results of these studies demonstrate that the drug is safe and effective, the pharmaceutical company can submit a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA for review. The application includes data from the clinical trials, as well as information about the manufacturing process, labeling, and proposed use of the drug.

The FDA reviews the application and may seek input from independent experts before making a decision on whether to approve the drug. If approved, the drug can be marketed and sold to patients with the medical condition for which it was approved. The FDA continues to monitor the safety and efficacy of approved drugs after they reach the market to ensure that they remain safe and effective for their intended use.

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page 4. Research, Center for Drug Evaluation and (2 November 2021). "About the Center for Drug Evaluation and Research - Drug ... In its original form, CDER was composed of six offices: Management, Compliance, Drug Standards, Drug Evaluation I, Drug ... Center for Drug Evaluation and (3 March 2022). "About the Center for Drug Evaluation and Research - CDER Offices and Divisions ... The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug ...
... for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public ... Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced ... In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must ... The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy ...
Drug Safety and Risk Management Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee Gastrointestinal Drugs ... The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration ( ... In 1987, under Commissioner Frank Young, CBER and the Center for Drug Evaluation and Research (CDER) were split into their ... Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER). ...
Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - What's in a REMS?". www.fda.gov. ... Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - FDA's Role in Managing Medication ... Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - Frequently Asked Questions (FAQs ... REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be ...
Evaluation Review. 22 (1): 15-45. doi:10.1177/0193841X9802200102. PMID 10183299. S2CID 25765373. Retrieved 2022-02-10. " ... In 2020, SSDP International was War On Drugs Prohibition (drugs) Drug policy "The Student Movement to End the Drug War Has a ... Protugal's drug policy, implemented in 2001, is based on the principle of harm reduction. Drug use and possession for personal ... Portugal's drug policy has been successful in reducing drug use and associated harms, including HIV infections and overdose ...
"Long-Term Impact of Drug Abuse Resistance Education (DARE)". Evaluation Review. 21 (4): 483-500. doi:10.1177/0193841X9702100404 ... and Other Drugs Blueprint Drug Education Forum Positive Futures Programme Talk to Frank Positive Choices Drug Education portal ... Alcohol education Responsible drug use Midford, Richard (2007). "Is Australia 'fair dinkum' about drug education in schools ... These education programs aim to educate adolescents about illicit drug use in an effort to prevent illegal drug use while ...
Drug use/ utilization evaluation and medication utilization evaluations are the same as drug utilization review. With the ... drug-drug interaction, drug-disease interaction, patient prevention with drug, over-utilization and under-utilization, drug ... Then, how to use drug utilization evaluation and drug economy evaluation to improve and optimize the allocation of medical and ... There are some issues addressed by this review: drug abuse clinically, alteration of drug dosage, drug-drug interaction, and ...
"Zotepine" (PDF). New Drug Evaluation. 36. October 1999. Archived from the original (PDF) on 2004-06-19. (CS1 Brazilian ... Zotepine is an atypical antipsychotic drug indicated for acute and chronic schizophrenia. It has been used in Germany since ... In a 2013 study in a comparison of 15 antipsychotic drugs in effectivity in treating schizophrenic symptoms, zotepine ... "Zotepine". Martindale: The Complete Drug Reference. Royal Pharmaceutical Society of Great Britain. 16 August 2013. Retrieved 2 ...
Council on Drugs (American Medical Association) (1964). New and Nonofficial Drugs. Lippincott. p. 739. Wiser I, Balicer RD, ... "Vaccine "Take" Evaluation". CDC. U.S. Centers for Disease Control and Prevention. Archived from the original on 26 January 2022 ... "Register of Innovative Drugs" (PDF). Health Canada. June 2020. Archived (PDF) from the original on 26 June 2020. Retrieved 24 ... U.S. Food & Drug Administration. Archived from the original on 8 October 2021. Retrieved 8 October 2021. " ...
... the EMA granted the drug a marketing authorisation for use of the drug as an add-on to other anti-seizure drugs. It was ... "Scientific evaluation" (PDF). EMA. 2007. Stiripentol (Diacomit): For Severe Myoclonic Epilepsy in Infancy (Dravet Syndrome) ( ... "Drug Approval Package: Diacomit (stiripentol)". U.S. Food and Drug Administration (FDA). 7 September 2018. Retrieved 8 November ... Drugs with non-standard legal status, ECHA InfoCard ID from Wikidata, Drug has EMA link, Drugboxes which contain changes to ...
... monitoring and evaluation; training and distribution cascade; drug management and coordination. Deworm the World and the ... This included a piece by Nicholas Kristof of The New York Times on the importance of impact evaluations in determining policy. ... In 2004, Edward Miguel and Michael Kremer published the results of an impact evaluation on school-based deworming in Kenya. ... he has pioneered the use of randomized controlled trials and other rigorous evaluation methods to test the impact of ...
The European Commission and the U.S. Food and Drug Administration (FDA) granted orphan drug status to trabectedin for soft- ... "CHMP evaluation" (PDF). "PharmaMar website". Archived from the original on September 18, 2008. "S.Korea approves Zeltia cancer ... Antineoplastic drugs, Benzodioxoles, Johnson & Johnson brands, Orphan drugs, Phenols, Total synthesis). ... But the better the drugs turn out to be, the greater the threat to the animals that produce them". New Scientist. Corey EJ, Gin ...
2003). In evaluations of the National Drug Strategic Framework 1998-99 - 2003-04, "National Drug Strategy 2010-2015". ... Illicit drug use in Australia is the recreational use of prohibited drugs in Australia. Illicit drugs include illegal drugs ( ... "Support drug law reform". reason.org.au. Retrieved 3 September 2022. Global Commission on Drugs (June 2011). War on Drugs. ... Australian National Council on Drugs Cannabis in Australia Crime in Australia Drug courts in Australia Drug liberalization Drug ...
ISBN 978-0-470-86893-5. Vogel, H. Gerhard (2006). Drug discovery and evaluation: safety and pharmacokinetic assays. Springer. p ... ISBN 1-58829-332-7. Gad, Shayne Cox (2009). "Genotoxicity". Drug Safety Evaluation. Pharmaceutical Development Series (2nd ed ... The S9 fraction is most frequently used in assays that measure the metabolism of drugs and other xenobiotics. It is defined by ... The S9 fraction has also been used to assess the metabolic stability of candidate drugs. Duffus JH, Nordberg M, Templeton DM ( ...
Drug Safety Evaluation. Methods in Molecular Biology. Vol. 691. pp. 69-82. doi:10.1007/978-1-60761-849-2_4. ISBN 978-1-60327- ... Slaoui, Mohamed; Fiette, Laurence (2011). "Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation". ...
Australian Drug Evaluation Committee. Archived from the original on 2007-06-05. Retrieved 2008-05-21. - links provided for 1999 ... The rule does not affect the labeling of over-the-counter drugs or of drugs approved prior to June 30, 2001. Australia has a ... February 1996). "Drugs during pregnancy: an issue of risk classification and information to prescribers". Drug Saf. 14 (2): 69- ... is now available in the individual drug monographs. American law requires that certain drugs and biological products must be ...
Center for Drug Evaluation. Retrieved 19 May 2017. Potter 2013, p. 897. Harrison, E. M.; Weinert, L. A.; Holden, M. T. G.; ... Common adverse drug reactions (≥ 1% of people) associated with use of the penicillins include diarrhea, hypersensitivity, ... Model of Structure of Penicillin, by Dorothy Hodgkin et al., Museum of the History of Science, Oxford Food and Drug ... Cooper, Chuck (9 January 2015). "Bioterrorism and Drug Preparedness - Safety of Long Term Therapy with Penicillin and ...
Research and Evaluation; Legal and Compliance; and Finance and Operations. DAODAS is a cabinet-level agency, with its Director ... The South Carolina Department of Department of Alcohol and Other Drug Abuse Services (DAODAS) is a state agency in the state of ... The department contracts with the state's county alcohol and drug abuse authorities to provide the majority of direct ... https://www.daodas.sc.gov "Code of Laws - Title 44 - Chapter 49 - Department of Alcohol and Other Drug Abuse Services". "As ...
Vogel, Hans J. (2002). Drug Discovery and Evaluation. Berlin: Springer. ISBN 3-540-42396-6. Jones, Jack (15 July 1988). "People ...
"Do Adult Drug Courts Work? National Results from the Multi-Site Adult Drug Court Evaluation (MADCE)." PsycEXTRA Dataset, 2010, ... Drug Court Judge Joseph Christ died of a drug overdose. Christ and another judge purchased their drugs from a drug court ... The National Association of Drug Court Professionals Drug Court Standards Committee. (1997, January). Defining Drug Courts: Ten ... evaluations, and relevant commentary. NDCI stages over 130 training events each year. In recent years, drug courts and drug ...
Drugs.com. Kusiak V (2013-02-13). "NDA Approval" (PDF). U.S. Food and Drug Administration. Center for Drug Evaluation and ... McCall JL, DeGregorio MW (June 2010). "Pharmacologic evaluation of ospemifene". Expert Opin Drug Metab Toxicol. 6 (6): 773-9. ... A New Drug Application (NDA) was submitted to the FDA on April 26, 2012. Amendments to the NDA were submitted in June, July, ... Estradiol was used as a positive control and raloxifene was used because it is in the same drug class as ospemifene. Multiple ...
Clayton, Anita H; Brown, Louise; Kim, Noel N (2020-01-02). "Evaluation of safety for flibanserin". Expert Opinion on Drug ... However, the drug slows down gastric emptying, which can cause an impact on oral drug uptake and the subsequent drug ... Thus, sexually active people are suggested to avoid the usage of the following drugs: Antihypertensive drugs Anti-anxiety drugs ... These drugs are all approved by the US FDA, and their working principles target both sexes equally. This class of drugs ...
Clinical Measurement in Drug Evaluation. Edited by Nimmo WS, Tucker GT. New York: Wiley; 1995. Pedersen TR, Olsson AG, ... "Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure". Food and Drug Administration. 28 February 2022 ... The company countered that rosuvastatin had been tested on larger groups of patients than any other drug in the class, and that ... In HIV/AIDS medicine, CD4 counts and viral loads are used as surrogate markers for drug approval for clinical trials. In ...
388M in spending in spite of being a low-cost generic drug. Piperacillin-tazobactam is recommended as part of a three-drug ... Identical evaluations are shown when compared to the imipenem and tobramycin combination, where the administration of ... and endangering patients to drug exposure. Although the distribution of the drug remained the same, the half-life for ... By contrast, the drug efficacy of ceftazidime and piperacillin-tazobactam resulted in similar response rates (61.5% and 63.9 ...
Moyle G (March 1998). "A re-evaluation of zalcitabine". Expert Opinion on Investigational Drugs. Informa Healthcare. 7 (3): 451 ... "Use of viral resistance patterns to antiretroviral drugs in optimising selection of drug combinations and sequences". Drugs. ... and accordingly the drugs should not be administered together. Additionally, zalcitabine should not be used with other drugs ... History of an AIDS drug. "HIVID (zalcitabine) tablets" (PDF). M.D./alert. U.S. Food and Drug Administration. June 2006. ...
The First Anti-Angiogenic Small Molecule Drug Candidate. Design, Synthesis and Clinical Evaluation". Anti-Cancer Agents in ... increasing concentration of the drug at the site of action and decreasing drug concentration elsewhere, thereby increasing the ... clinical use and new drugs". Nature Reviews Drug Discovery. 15 (3): 173-183. doi:10.1038/nrd.2015.10. PMC 4890615. PMID ... The discovery of RGD and elucidation of how RGD binds to integrins has led to the development of a number of drugs and ...
Drug Evaluation and Classification Program. NHTSA. pp. Sev IV Pg. 5-6. DECP Annual Report.pdf "Drug Evaluation and ... In B.C., the officer can further order a drug recognition evaluation by an expert, which can be used as evidence of drug use to ... The Drug Evaluation and Classification program is designed to detect a drug impaired driver and classify the categories of ... and drug recognition evaluations to determine whether the officer believes the driver is under the influence of drugs." In the ...
"Dimetindene". Drugs.com. Noguchi S, Inukai T, Kuno T, Tanaka C (June 1992). "The suppression of olfactory bulbectomy-induced ... Wexler L (June 1962). "A clinical evaluation of dimethindene". Current Therapeutic Research, Clinical and Experimental. 4: 306- ... Fischer J, Ganellin CR (2006). Analogue-based Drug Discovery. John Wiley & Sons. p. 547. ISBN 9783527607495. ...
Center for Drug Evaluation Research. 3 November 2018. Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, et al. ( ... "First Generic Drug Approvals". U.S. Food and Drug Administration. 17 October 2022. Retrieved 28 November 2022. Pao W, Miller V ... Drugs with non-standard legal status, ECHA InfoCard ID from Wikidata, Drug has EMA link, Drugboxes which contain changes to ... Food and Drug Administration. "Lung cancer drug 'could help treat ectopic pregnancy'". BBC News. 9 September 2013. Mok TS, Wu ...
Evaluation of Drugs: Whose Responsibility? Liège, Belgium, 1968 IV. Medical Research: Priorities and Responsibilities, Geneva, ... Drug Abuse: Non-Medical Use of Dependence-Producing Drugs, Geneva, Switzerland, 1971 VII. Recent Progress in Biology and ... Benefit-Risk Balance for Marketed Drugs: Evaluation of Safety Signals Standardized Medical Dictionary for Regulatory Activities ... International Reporting of Adverse Drug Reactions Working Group II (founded 1992): International Reporting of Periodic Drug- ...
The evaluation of these efforts is essential to ensure program fidelity, efficacy, and efficiency. ... Evaluation Profiles. The following OD2A evaluation profiles, created with funded jurisdictions between 2019-2023, can be used ... The OD2A evaluation team works to support OD2A-funded jurisdictions in their evaluation efforts by providing individualized ... including prescription drug misuse and illicit drug use, and reducing stigma associated with opioid use disorder. ...
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Jobs at the Center for Drug Evaluation and Research ... Jobs at the Center for Drug Evaluation and Research (CDER) * ... Jobs at the Center for Drug Evaluation and Research (CDER). At FDAs CDER, you can make a difference in protecting the health ... Jobs at the Center for Drug Evaluation and Research (CDER) *Calendar of Upcoming Events ... Jobs at the Center for Drug Evaluation and Research (CDER) *Calendar of Upcoming Events ...
Eight drug and alcohol recovery Payment by Results pilots were evaluated to assess whether this new funding approach can ... Evaluation of drug and alcohol recovery "payment by results" pilots. Evaluation of drug and alcohol recovery "payment by ... Evaluation of the Drugs and Alcohol Recovery Payment by Results Pilot Programme: Final Report 11 April 2019. Michael Donmall, ... An evaluation of how the PbR approach can help to provide different schemes that support the recovery of individuals from drug ...
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Reporting the Units Family Drug and Alcohol Court evaluation. Mary Baginsky was at the International Society of Family Law ... The presentation was based on the evaluation of the post-proceedings programme attached to Gloucestershires FDAC, a project ... The evaluation report will be available at the end of August 2023. ... providing post-proceedings support to parents graduating from A Family Drug and Alcohol Court (FDAC). ...
Reference Listed Drug: No Reference Standard: No TE Code: Application Number: A083535 Product Number: 001 Approval Date: ... Reference Listed Drug: No Reference Standard: No TE Code: Application Number: A083535 Product Number: 002 Approval Date: ...
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive ... Quantitative Drug Safety and Benefit Risk Evaluation Practical and Cross-Disciplinary Approaches Edited By William Wang, Melvin ... Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive ... James Buchanan, president of Covilance LLC, has 30+ years of drug safety experience in the pharmaceutical industry. He is a co- ...
Some monodisperse drag models scale a drag coefficient by the voidage to predict the drag in a bed. For beds of non-spherical ... 400p) Drag Model Evaluation through Fluidized Beds and Free-Falling Particles. Conference ... The models for the drag coefficient play a significant role in the accuracy of these predictions. One common agreement is that ... Drag models are evaluated for two different conditions: particles in a bed and accelerating particles. ...
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Safety attrition of drugs during preclinical development as well as in late-stage clinical trials continues to be a challenge ... Evaluation of drugs with specific organ toxicities in organ-specific cell lines Toxicol Sci. 2012 Mar;126(1):114-27. doi: ... Safety attrition of drugs during preclinical development as well as in late-stage clinical trials continues to be a challenge ... In recent years, efforts have been made to identify such liabilities earlier in the drug development process, through ...
High Throughput Multi-Omics Approaches for Clinical Trial Evaluation and Drug Discovery. Jessica M. Zielinski1 Jason J. Luke2 ... High Throughput Multi-Omics Approaches for Clinical Trial Evaluation and Drug Discovery. Front. Immunol. 12:590742. doi: ... which in our view limit the accessibility of high dimensional technologies to clinical trial evaluation and drug discovery. The ... Single-cell mass cytometry of differential immune and drug responses across a human hematopoietic continuum. Science Am Assoc ...
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Gupta D Hormonal Evaluation in Young Drug Addicts J.Pharmacol. 1974 5(Suppl. 2):46 ... "Hormonal Evaluation in Young Drug Addicts" J.Pharmacol.. 1974;5(Suppl. 2):46. ... Drug addiction in young subjects is usually accompanied by various neuropsychological problems but the condition also needs ... the characteristic neuropsychological features of drug effect and reduction in gonadat steroid concentration suggests drug- ...
Evaluation: 2023 January Future Food Regulation Webinar Webinar Evaluation: The Future of Food Regulation: Assessing the Reagan ... FOOD AND DRUG LAW INSTITUTE. 1015 15th St NW, Suite 300. Washington, DC 20005. Contact Us. Terms of Use , Privacy Policy ... and engagement opportunities for the food and drug law community.. Please enable JavaScript in your browser to complete this ...
Evaluation of the Drug Treatment Court Funding Program Survey. As someone who is involved with Drug Treatment Courts (DTCs) and ... 1. The evaluation covers the Drug Treatment Courts (DTCs) funded by the Drug Treatment Court Funding Program (DTCFP) in Toronto ... Relevance of the Drug Treatment Courts and the Drug Treatment Court Funding Program. 35. What do you feel are the unique needs ... Has your drug use changed since you were in the Drug Treatment Court Program? (Probe: complete abstinence/reduced use/no change ...
We sought to develop and evaluate a comprehensive yet brief Measure of Drug Self-Management (MeDS) for use in research and ... Current adherence scales often fail to assess the full spectrum of behaviors associated with safe and appropriate drug use and ... Development and evaluation of the Measure of Drug Self-Management Stacy Cooper Bailey,1 Izabela E Annis,1 Daniel S Reuland,2 ... Prescription drug use continues to increase: U.S. prescription drug data for 2007-2008. NCHS data brief, no 42. Hyattsville, MD ...
Evaluation of hydroxypropyl methylcellulose matrix systems as swellable gastro-retentive drug delivery systems (GRDDS). ... Evaluation of hydroxypropyl methylcellulose matrix systems as swellable gastro-retentive drug delivery systems (GRDDS). J Pharm ... Evaluation of Hydroxypropyl Methylcellulose Matrix Systems as Swellable Gastro-retentive Drug Delivery Systems (GRDDS). J Pharm ... Evaluation of hydroxypropyl methylcellulose matrix systems as swellable gastro-retentive drug delivery systems (GRDDS).. J ...
The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the reference point on drugs and drug addiction ... The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the leading authority on illicit drugs in the European ... The public consultation will provide an important contribution to the evidence base for the mid-term evaluation of the EU Drugs ... Evaluation of the EU Drugs Strategy and Action Plan (2013-2016): public consultation ...
Jankel CA and Fitterman LK (1993) Epidemiology of drug-drug interactions as a cause of hospital admissions. Drug Safety 9: 51- ... McGinnity DF, Soars MG, Urbanowicz RA, and Riley RJ (2004) Evaluation of fresh and cryopreserved hepatocytes as in vitro drug ... Zhao P, Kunze KL, and Lee CA (2005) Evaluation of time-dependent inactivation of CYP3A in cryopreserved human hepatocytes. Drug ... Silva JM and Nicoll-Griffith DA (2002) In vitro models for studying induction of cytochrome P450 enzymes, in Drug-Drug ...
New polymers for drug delivery systems in orthopaedics: in vivo biocompatibility evaluation ... New polymers for drug delivery systems in orthopaedics: in vivo biocompatibility evaluation. Biomedicine and Pharmacotherapy, ... The use of biodegradable polymers for drug delivery systems excluded the need for a second operation to remove the carrier. ... However, the development of an avascular fibrous capsule, reducing drug release, has raised concern about these polymers in ...
Drug Courts aim to help people address their illicit drug dependence which has resulted in criminal offending. The NSW Drug ... The BOCSAR evaluations have played an important role in the expansion of the NSW Drug Court, which now sits in four locations: ... The most recent evaluation of the long-term effects of the NSW Drug Court published in 2020 compared people accepted into the ... Topic: Evaluation of the NSW Drug Court: Methods, Successes and Opportunities. Location: online via zoom, details will be ...
Note: LifePearl™ microspheres can be loaded with chemotherapeutic drugs. When used for drug loading, drug loading should be ... Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: ... The use of the LifePearl™ devices in combination with drugs is not cleared or approved in the USA by the Food and Drug ... Transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended for patients with BCLC stage B ...
Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals ... Pharmacological screening of herbal drugs. 15. Antimicrobial and parasiticidal screening of herbal drugs. 16. Screening for ... evaluation, quality control and standardization of herbal drugs from different chapters of this book. ... Herbal drugs have become one of the totems in this era of phytotherapy. the medicinal plants have enormous commercial ...
To help minimize the risk of potentially dangerous side effects, Congress authorized the U.S. Food and Drug Administration (FDA ... to develop the Risk Evaluation and Mitigation Strategies (REMS) program, which requires pharmaceutical companies to design ...
Evaluation of a Soluble Tetrazolium/Formazan Assay for Cell Growth and Drug Sensitivity in Culture Using Human and Other Tumor ... In the presence of PMS, the XTT reagent yielded usable absorbance values for growth and drug sensitivity evaluations with a ... Evaluation of a Soluble Tetrazolium/Formazan Assay for Cell Growth and Drug Sensitivity in Culture Using Human and Other Tumor ... Drug profiles obtained with representative human tumor cell lines for several standard compounds utilizing the XTT-PMS ...
  • To better facilitate provision of care, the Centers for Disease Control and Prevention (CDC) has organized this COCA Call to help improve understanding among clinicians of the concerns of people who use drugs and people who have a substance use disorder. (cdc.gov)
  • The following OD2A evaluation profiles, created with funded jurisdictions between 2019-2023, can be used to help state and local health departments, community-based organizations, medical and healthcare professionals, and program managers determine how well programs and initiatives are being implemented. (cdc.gov)
  • Dr Mary Baginsky gave a presentation at the International Society of Family Law 18th World Conference in Antwerp (July 12-15, 2023) on Support to maximise success: providing post-proceedings support to parents graduating from A Family Drug and Alcohol Court (FDAC) . (kcl.ac.uk)
  • The evaluation report will be available at the end of August 2023. (kcl.ac.uk)
  • Utilizing gastro-retentive drug delivery systems (GRDDS) to increase absorption of weakly basic drugs by extending their transit time is a promising approach. (unboundmedicine.com)
  • The aim of this work was to design and evaluate effervescent floating gastro-retentive drug delivery matrix tablets with sustained-release behavior using a binary mixture of hydroxyethyl cellulose and sodium alginate. (scienceopen.com)
  • Therefore, two-fluid simulations are performed with the current drag models to compare the flow behaviors. (aiche.org)
  • Current adherence scales often fail to assess the full spectrum of behaviors associated with safe and appropriate drug use and may be unsuitable for patients with limited health literacy. (dovepress.com)
  • The floating capacity, swelling, and drug release behaviors of drug-loaded matrix tablets were evaluated in 0.1 N HCl (pH 1.2) at 37°C±0.5°C. Release data were analyzed by fitting the power law model of Korsmeyer-Peppas. (scienceopen.com)
  • When drug and alcohol abuse gets out of control, an individual can even find themselves engaging in activities and behaviors that could endanger their health, jeopardize the safety of those around them, and land them in trouble with the law. (aacsatlanta.com)
  • Safety attrition of drugs during preclinical development as well as in late-stage clinical trials continues to be a challenge for the pharmaceutical industry for patient welfare and financial reasons. (nih.gov)
  • In 2017 she was appointed as a Judge of the Drug Court of NSW and in 2021 as Senior Judge. (aes.asn.au)
  • Alcohol and Drug Evaluation Nebraska - Virtual Services with Guaranteed Acceptance Nationwide by Accredited and Licensed Clinicians - AOD For Court, Probation, Parole, Driving Under the Influence (DUI), Possession Cases, and all Employment Assessments. (ewire.com)
  • Alcohol and Drug Evaluations are NON-DUI assessments. (ewire.com)
  • The negative impact of student alcohol and drug use is often felt in the broader Auburn community through noise, vandalism, vehicle crashes, and use of community resources such as Auburn Public Safety and East Alabama Medical Center. (auburn.edu)
  • Alcohol and Drug Prevention programs and policies of Auburn University are designed to support the larger mission of the University as well as the time-honored values of the Auburn Family. (auburn.edu)
  • Auburn University relies on evidence-based and theory-driven public health research, theory, and practice in developing comprehensive alcohol and drug prevention programs and policies. (auburn.edu)
  • Alcohol and Drug Evaluation (aka, Substance Abuse Evaluation) includes a clinical component using standardized psychosocial assessment tools, and a detailed written report describing the results. (sigmacounseling.com)
  • The alcohol and drug evaluation process leads to an accurate diagnosis along with recommendations designed to help individuals make informed decisions about the next step. (sigmacounseling.com)
  • The Alcohol and Drug Evaluation counselor provides a preliminary diagnosis of an individual's chemical dependency and recommendations for treatment to address specific needs. (sigmacounseling.com)
  • Alcohol and Drug Evaluation Georgia are often court-ordered and recommended by a criminal defense attorney or probation officer for alcohol or drug-related charges. (aacsatlanta.com)
  • The most common situations which most often require individuals to seek an alcohol and drug evaluation include charges such as public intoxication, prostitution, reckless driving, disorderly conduct, and possession of controlled substances. (aacsatlanta.com)
  • The primary purpose of a court-ordered Alcohol and Drug Evaluation Marietta is to comprehensively assess any symptoms present in an individual regarding alcohol and drug use. (aacsatlanta.com)
  • Think of a court-ordered Alcohol and Drug Evaluation Georgia as a tool used by doctors and addiction specialists to assess the level and extent of an individual's drug, alcohol, and other addictive substance abuse and misuse. (aacsatlanta.com)
  • A court-ordered Alcohol and Drug Evaluation Georgia is confidentially administered on an outpatient basis in a private setting. (aacsatlanta.com)
  • Most court-ordered Alcohol and Drug Evaluations include intake forms with pre-screening assessments and questionnaires followed by a one-on-one interview. (aacsatlanta.com)
  • In addition, the tests do show impairment that can be caused by other things such as prescription or illicit drugs. (gc.ca)
  • The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the leading authority on illicit drugs in the European Union. (europa.eu)
  • For example, two large-scale evaluations of hepatotoxic compounds have been conducted. (nih.gov)
  • After the evaluation, the toxicological sample is sent to a forensic laboratory for analyses to confirm the findings of the evaluator. (gc.ca)
  • Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. (taylorfrancis.com)
  • Implementation fidelity of the Programmatic Management guidelines for the treatment of Drug-resistant Tuberculosis was measured under the four domains of content, coverage, duration and frequency. (researchsquare.com)
  • Such strategies may go a long way to reduce the incidence of hearing loss, thus improving patients compliance with the treatment regimen, and ultimately reducing the burden of drug resistant tuberculosis in Nigeria. (researchsquare.com)
  • Title : Mycobacterium tuberculosis complex drug susceptibility testing program model performance evaluation program report of results Personal Author(s) : Stafford, Cortney;Metchock, Beverly;Johnston, Stephanie;Diem, Lois;Yakrus, Mitchell A.;Starks, Angela M. (cdc.gov)
  • In 2004, routine use of culture and drug-susceptibility testing (DST) was implemented for persons in 5 Thailand provinces with a diagnosis of tuberculosis (TB). (cdc.gov)
  • An assessment of the potential of a new chemical entity to cause DDIs via inhibition of P450 metabolism is important early in the drug discovery process. (aspetjournals.org)
  • SCPS Provides assessment, education and first-level intervention (individual & group counseling) for students with alcohol and other drug concerns. (auburn.edu)
  • This evaluation is also known as a chemical dependence assessment/evaluation and as a substance abuse assessment/evaluation. (sigmacounseling.com)
  • Legacy data sharing to improve drug safety assessment: the eTOX project" Ferran Sanz, François Pognan, Thomas Steger-Hartmann, Carlos Díaz and eTOX (including Manuel Pastor). (imim.cat)
  • Science, politics, and the pharmaceutical industry : controversy and bias in drug regulation / John Abraham. (who.int)
  • An Overview of FDA's Regulation of Rx Drugs - From Research to Your Medicine Cabinet - Are Your Prescription Drugs Safe and Effective? (thefdalawblog.com)
  • An Overview of Generic Drug Regulation in the United States - The Continuing Struggle to Reduce the Cost of Rx Drugs and Stimulate the Development of New Therapies. (thefdalawblog.com)
  • The Australian Drug Evaluation Committee or ADEC, was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs. (wikipedia.org)
  • Each major therapeutic area is considered by class of activity of drug. (taylorfrancis.com)
  • Therapeutic potentials of herbal drug ranges from parts of plants, through simple extracts to isolated active constituents. (saujanyabooks.com)
  • The patient who has a therapeutic level of prescription drugs in his or her system will be able to carry on in life in an absolutely normal fashion. (winning-dwi-defenses.com)
  • While DREs use the drug matrix, they also rely heavily on their general training and experience. (gc.ca)
  • The National Highway Traffic Safety Administration (NHTSA) and the International Association of Chiefs of Police (IACP) developed the drug evaluation and classification program (DECP) to certify law enforcement officers as drug recognition experts (DREs). (liberty.edu)
  • The purpose of the study was to evaluate the DECP in Florida to determine the accuracy rates of DREs and determine which core set of measurements (signs and symptoms) from the drug influence evaluation (DIE) face sheets correspond to each of the seven drug categories, and to determine if any core set of measurements from the DIEs are identified with the inaccuracies of DRE opinions. (liberty.edu)
  • The study also completed a binary logistic regression analysis to determine the core set of measurements (signs and symptoms) to predict the drug categories determined by toxicology results and the core set of measurements (signs and symptoms) to predict the drug categories inaccurately determined by the DREs. (liberty.edu)
  • The EU Drugs Strategy provides a political framework and priorities for action in the field of drug policies for the period 2013-2020. (europa.eu)
  • The most recent evaluation of the long-term effects of the NSW Drug Court published in 2020 compared people accepted into the Drug Court with those referred to but not accepted onto the program, and found participants were significantly less likely to be reconvicted than the comparison group. (aes.asn.au)
  • In this online seminar you will hear from Judge Jane Mottley, Senior Judge of the NSW Drug Court, and Dr Suzanne Poynton, Director of Research and Evaluation at BOCSAR and co-author of the 2020 evaluation. (aes.asn.au)
  • She has more than 60 publications on a wide range of topics, including a recent paper on the long term effect of the NSW Drug Court on recidivism (BOCSAR Crime and Justice Bulletin 232, 2020, with Weatherburn, Yeong, Jones & Farrell). (aes.asn.au)
  • The Role of Mass Spectrometry in Drug Discovery and Development presented by Walter A. Korfmacher (Merck Research Labs) on May 23, 2010. (asms.org)
  • 15. Antimicrobial and parasiticidal screening of herbal drugs. (saujanyabooks.com)
  • A confirmed case of invasive DRSP is defined as either meningitis or bacteremia in which S. pneumoniae cultured from CSF or blood is identified as nonsusceptible (using National Committee for Clinical Laboratory Standards {NCCLS} methods and breakpoints) to antimicrobial drugs currently approved for treating pneumococcal infections. (cdc.gov)
  • P289 Evaluation of the safety and effectiveness of direct-acting antiviral drugs in the treatment of hepatitis C in patients with inflammatory bowel disease: National multicenter study (ENEIDA registry). (ecco-ibd.eu)
  • The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. (taylorfrancis.com)
  • 1 - 5 While estimates of non-adherence vary depending upon how adherence is measured and the characteristics of the drug in question, evidence suggests that approximately half of US patients do not take medication as prescribed. (dovepress.com)
  • 6 Ensuring that patients take medications safely, appropriately, and consistently has therefore become a public health issue, particularly for the growing number of patients managing chronic diseases that require multi-drug regimens. (dovepress.com)
  • While devices like medication event monitoring system (MEMS) caps have advanced the measurement of medication adherence, they are often too costly to use in practice, especially when patients take multiple drugs. (dovepress.com)
  • Transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended for patients with BCLC stage B hepatocellular carcinoma (HCC) and stage 0-A unsuitable for curative treatments (i.e. surgery or ablation). (terumo-europe.com)
  • To help minimize the risk of potentially dangerous side effects, Congress authorized the U.S. Food and Drug Administration (FDA) to develop the Risk Evaluation and Mitigation Strategies (REMS) program, which requires pharmaceutical companies to design steps to help patients, caregivers, providers, and other stakeholders mitigate risks. (kpihp.org)
  • Patients should not stop taking any prescription drug without seeking the advice of their medical doctor. (druginjurylaw.com)
  • The factors suggested for the rising incidence include (i) limited qualified personnel to implement the management guidelines, (ii) lack of appropriate audiological equipment for screening the patients on injectable second-line anti-TB drugs, (iii) health care personnel's negative attitude towards patients with hearing loss, and (iv) lack of adherence to the DR-TB guidelines/improper implementation of the guideline (Carroll et al. (researchsquare.com)
  • Unresolved drug therapy-related problems (DTRPs) have economic and clinical consequences and are common causes of patients' morbidity and mortality. (biomedcentral.com)
  • 5 ], the prevalence of hospital admission due to DTRPs range from 1.3-43% and 7% of hospitalized patients were reported to have died from drug-related problems. (biomedcentral.com)
  • Besides prescribed drugs, patients also engage in self-medication which may not be declared to the physicians or is purchased after a hospital visit. (biomedcentral.com)
  • Drug-induced uveitis should be considered in patients with unexplained uveitis beginning days to months after starting a new medication. (aafp.org)
  • This review provides a framework for primary care physicians who are asked to examine patients with uveitis when an underlying systemic diagnosis is suspected after ophthalmologic evaluation. (aafp.org)
  • To evaluate the relationship between white matter integrity and serum cortisol levels during a first depressive episode in drug-naive patients with MDD (MDD group) using a tract-based spatial statistics (TBSS) method. (cambridge.org)
  • Plus d'un million de patients atteints de tuberculose ont été soignés depuis 2000, avec un taux de réussite thérapeutique de 91 % en 2007. (who.int)
  • Do Drug Accessibility and OOP Burden Affect Health-Related Quality of Life of Patients With Chronic Diseases? (lu.se)
  • Purpose: The dependence of patients with chronic diseases on drugs may affect their health-related quality of life (HRQoL). (lu.se)
  • Conclusion: In order to improve the quality of life of patients with chronic diseases, it is of great importance to ensure the accessibility of drugs and reduce patients' medication burden. (lu.se)
  • The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for monoclonal antibodies to treat COVID-19 for certain patients. (cdc.gov)
  • The overall aim of the evaluation was to investigate whether, how, and to what extent a PbR approach can stimulate the market to provide different schemes, co-ordinated across a range of services, that successfully initiate and sustain the recovery of individuals from drug and alcohol dependence and their successful re-integration into their communities. (rand.org)
  • Drug Courts aim to help people address their illicit drug dependence which has resulted in criminal offending. (aes.asn.au)
  • In 2010, ADEC was replaced by the Advisory Committee on Prescription Medicines (ACPM) ADEC provided advice to the Minister for Health and Ageing and the Secretary of the Department of Health on: quality, risk-benefit, effectiveness and accessibility of drugs referred to ADEC for evaluation medical and scientific evaluations of applications for registration of new drugs An important role of ADEC was the classification of drugs in Australia into pregnancy categories. (wikipedia.org)
  • the Pharmaceutical Subcommittee - which made recommendations to ADEC on the pharmaceutical aspects (chemistry, quality control, pharmacokinetics, etc.) of drugs proposed for registration (replaced by the pharmaceutical subcommittee of the ACPM). (wikipedia.org)
  • Novel sustained release, swellable and bioadhesive gastroretentive drug delivery system for ofloxacin. (scienceopen.com)
  • The evaluation must show impairment, signs and symptoms consistent with one or more drug categories, and the evaluator's findings must be supported by the toxicology. (gc.ca)
  • As a result, the presence of specific signs and symptoms, bothersome enough to lead a patient to seek health care, becomes a crucial determinant, along with thorough evaluation by the physician. (oncolink.org)
  • The OD2A evaluation team works to support OD2A-funded jurisdictions in their evaluation efforts by providing individualized technical assistance and creating overdose prevention evaluation resources. (cdc.gov)
  • 1-isopropylimidazolidine-2-thione: clinical evaluation of a new antithyroid drug. (who.int)
  • The primary objectives in a diagnostic evaluation for suspected cancer are determinations of the tissue type, the primary site of malignancy, the extent of disease within the body and the tumor's future recurrence potential. (oncolink.org)
  • CURES is committed to the reduction of prescription drug abuse and diversion without affecting legitimate medical practice or patient care. (ca.gov)
  • The improvement of drug accessibility and the reduction of the burden of out-of-pocket expenses have significant positive effects on HRQoL. (lu.se)
  • The profiles contain guidance on the types of evaluation questions, indicators, data sources, and data collection methods that can be used to evaluate the specified topics and activities. (cdc.gov)
  • He is a co-lead of the ASA Biopharmaceutical Safety Working Group and the Interactive Safety Graphics taskforce that is developing novel, open-source, interactive graphical tools to evaluate drug safety issues. (routledge.com)
  • We sought to develop and evaluate a comprehensive yet brief Measure of Drug Self-Management (MeDS) for use in research and clinical settings among diverse patient groups. (dovepress.com)
  • Therefore, in addition to enzyme activity, mRNA and/or protein levels should be measured to fully evaluate the P450 induction potential of a drug candidate. (aspetjournals.org)
  • Evaluate the university's drug and alcohol prevention program biennially to determine its effectiveness and ensure that disciplinary sanctions are consistently enforced. (auburn.edu)
  • Virtually every aspect of an individual's substance abuse history and contributing factors will be considered during the evaluation process. (aacsatlanta.com)
  • Some monodisperse drag models scale a drag coefficient by the voidage to predict the drag in a bed. (aiche.org)
  • and ensuring uninterrupted supply of quality anti-TB drugs, all requiring continued and coordinated technical and donor support. (who.int)
  • Dr. James Buchanan, president of Covilance LLC, has 30+ years of drug safety experience in the pharmaceutical industry. (routledge.com)
  • The bioavailability of drugs with an absorption window in the upper small intestine is generally limited with conventional pharmaceutical dosage forms. (scienceopen.com)
  • Provide recommendations to promote and further develop the university's drug and alcohol prevention program. (auburn.edu)
  • To help bridge that gap the Drug-Free Communities (DFC) program, a federally funded drug prevention and education program since 1997, focuses on reducing substance use in both youths and adults. (thenmi.org)
  • Expeditious evaluation is indicated after the diagnosis of HSE is considered. (medscape.com)
  • Drug addiction in young subjects is usually accompanied by various neuropsychological problems but the condition also needs systematic hormonal evaluation. (erowid.org)
  • The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the reference point on drugs and drug addiction information in Europe. (europa.eu)
  • Non-adherence to prescription drugs is highly prevalent and can jeopardize the effectiveness and safety of a patient's treatment. (dovepress.com)
  • Drug bioscreening : drug evaluation techniques in pharmacology / Emmanuel B. Thompson. (who.int)
  • AMA drug evaluations / prepared by the AMA Division of Drugs, in cooperation with the American Society for Clinical Pharmacology and Therapeutics. (who.int)
  • An independent evaluation of eight drug and alcohol recovery PbR pilots, commissioned by the Department of Health, assessed whether and how this new funding approach encourages the development of not only the market for provision of services in these areas but also more effective recovery programmes. (rand.org)
  • In recent years, efforts have been made to identify such liabilities earlier in the drug development process, through utilization of in silico and cytotoxicity models. (nih.gov)
  • Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs. (taylorfrancis.com)
  • Drug development is a long and costly process which suffers from the major shortcoming that frequently failure is often only determined during the final stage. (europa.eu)
  • However, the development of an avascular fibrous capsule, reducing drug release, has raised concern about these polymers in terms of tissue-implant reaction. (strath.ac.uk)
  • This international, peer-reviewed Open Access journal by Dove Medical Press focuses on the design and development of drugs, as well as the clinical outcomes, patient safety, and programs targeted at the effective and safe use of medicines. (scienceopen.com)
  • In recent years scientific and technological advancements have been made in the research and development of rate-controlled oral drug delivery systems by overcoming physiological adversities, such as short gastric residence times (GRT) and unpredictable gastric emptying times (GET). (scienceopen.com)
  • Alzheimer's disease : optimizing drug development strategies / Neal R. Cutler, John J. Sramek, Amy E. Veroff. (who.int)
  • The strategy is implemented through two EU Action Plans on Drugs, the first of which (2013-2016) will come to a close this year. (europa.eu)
  • The public consultation will provide an important contribution to the evidence base for the mid-term evaluation of the EU Drugs Strategy and Action Plan (2013-2016). (europa.eu)
  • The Drug Recognition Expert (DRE) uses a 12-step procedure in performing the evaluation. (gc.ca)
  • The State tries to link the finding of the prescription drug in the urine with the opinion of the drug recognition expert in order to come to this conclusion that the person is under the influence while driving (DWI). (winning-dwi-defenses.com)
  • This study aims to assess the relationship between the direct economic burden caused by out-of-pocket (OOP) payments, drug accessibility, sociodemographic characteristics, and health-related quality of life. (lu.se)
  • This text is intended to present elements of both methods and theoretical backgrounds of different aspects on quality control and standardization of herbal drugs and formulations. (saujanyabooks.com)
  • What's important to know about urine samples is that in New Jersey, the state laboratory only tests for the presence of drugs, not necessarily the amount. (winning-dwi-defenses.com)
  • Also, if the laboratory bothered to set up testing properly to determine the amount of marijuana or marijuana components in a person's blood that would give the state a major piece of evidence to show that the person is driving under the influence of drugs. (winning-dwi-defenses.com)
  • If the laboratory is looking for the presence of a prescription drug, well, of course they're going to find that in the person's urine. (winning-dwi-defenses.com)
  • This paper examines the strategic decisions and infrastructure improvements underlying this achievement, such as the implementation of universal DOTS coverage, expansion of the laboratory network, effective drug management systems, improved communication strategies, and inclusion of private practitioners, laboratories and hospitals in the TB control programme through the public-private mix strategy. (who.int)
  • Overdose communication campaigns can focus on raising awareness and educating the public about the drug overdose crisis, including prescription drug misuse and illicit drug use, and reducing stigma associated with opioid use disorder. (cdc.gov)
  • 6. Tell me about the substance abuse treatment that you have received in the Drug Treatment Court Program. (gc.ca)
  • When a person finds themself involved in a case brought before a court of law involving intoxication, drunkenness, or substance abuse, the judge might order that person to undergo a court-ordered evaluation to find out if any substance abuse disorders exist before sentencing. (aacsatlanta.com)
  • The pilot schemes were assessed by both process and impact evaluation. (rand.org)
  • The Consortium was led by the University of Manchester, with RAND Europe collaborating with Birkbeck College London to conduct the process evaluation. (rand.org)
  • Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. (routledge.com)
  • By comparing the responses of professionals with the literature review, it was concluded that the drug which has fewer side effects is ibuprofen, therefore the use of this drug on the inflammatory process when there is a need to control the inflammation of the pediatric patient. (bvsalud.org)
  • and three cross-cutting themes: coordination, international cooperation and information, research, monitoring and evaluation. (europa.eu)
  • Oral sustained release gastroretentive dosage forms offer many advantages for drugs having absorption from upper gastrointestinal tract and improve the bioavailability of medications that are characterized by a narrow absorption window. (scienceopen.com)
  • a retrospective and documentary study, based on secondary data, using the registration forms of all versions of the Specialization Courses to train researchers in alcohol and other psychoactive drugs (2002 to 2015), promoted by the Ribeirão Preto Nursing School, University of Sao Paulo. (bvsalud.org)
  • The prescription drugs discussed on this site are approved for use by the the Food and Drug Administration (FDA). (druginjurylaw.com)
  • Since most drugs for self-medication and prescription refills are obtained from the community pharmacies, community pharmacists are in a vantage position to detect and resolve DTRPs like their hospital counterpart. (biomedcentral.com)
  • They provide an overview of the processes a prescription drug must follow to be FDA-approved and the pervasive regulatory requirements that apply after FDA's approval. (thefdalawblog.com)
  • How about for prescription drugs, though? (winning-dwi-defenses.com)
  • In addition, the prescription drug could even be found in the urine days after it was taken. (winning-dwi-defenses.com)
  • After taking a deeper look into the symptoms present, the evaluation will determine whether these symptoms constitute an addictive disease or co-occurring psychiatric disorder. (aacsatlanta.com)
  • You will be asked to provide basic personal background information and fill out a standardized questionnaire about your current alcohol or drug use, your health history, your behavioral patterns, any symptoms you are experiencing, and the effects of the substance on your life. (aacsatlanta.com)
  • The evaluation of a suspected drug impaired driver is conducted by an evaluator who is accredited by the International Association of Chiefs of Police, through the RCMP. (gc.ca)
  • This "screening" phase is a preliminary evaluation that gives the evaluator a brief overview of the situation that warrants a more in-depth look. (aacsatlanta.com)
  • After the DRE evaluation, will the police ask for a chemical test, such as urine or blood? (winning-dwi-defenses.com)
  • Chemical Tests may be used in in Drug-Related Cases to detect which drug is affecting the driver's abilities. (winning-dwi-defenses.com)
  • If you are arrested for a drug related DWI charge in New Jersey, the officer will ask for a chemical test such as urine or blood sample. (winning-dwi-defenses.com)
  • The consultation seeks to gather views on the five objectives of the EU Drugs Strategy (and corresponding actions) and on the following evaluation criteria: effectiveness, efficiency, relevance, coherence and EU added value. (europa.eu)
  • Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation. (routledge.com)
  • We have developed a systemic approach that brings together the human networks, processes and scientific tools necessary for collecting, analysing and reporting on the many aspects of the European drugs phenomenon. (europa.eu)
  • Floating drug delivery systems: an approach to oral controlled drug delivery via gastric retention. (scienceopen.com)
  • Or call us toll-free at (800) 426-9535 to speak directly to attorney Tom Lamb about a possible drug injury case. (druginjurylaw.com)
  • If you have a possible case involving drug side effects, get your free, confidential, and no obligation case review by drug injury lawyer Tom Lamb. (druginjurylaw.com)
  • They could float on the surface of dissolution medium and sustain drug release over 24 hours. (scienceopen.com)
  • The COVID-19 pandemic has presented challenges in healthcare for those who may be at greater risk for adverse health outcomes such as people who use drugs or people who have a substance use disorder. (cdc.gov)
  • Judge Mottley and Dr Poynton will discuss the methodology, cost, findings and impact of the evaluation of the NSW Drug Court, and reflect on the broader implications for funding decisions and policy reform. (aes.asn.au)
  • She also has extensive experience working at the US Food and Drug Administration as a master statistical reviewer and supervisory mathematical statistician. (routledge.com)
  • Fill out the form below to receive emails highlighting our upcoming programs, early registration savings, and engagement opportunities for the food and drug law community. (fdli.org)
  • 2. How did you find out about the Drug Treatment Court Program? (gc.ca)
  • 4. Are you still participating in the Drug Treatment Court Program? (gc.ca)
  • 5. How long have you been in the Drug Treatment Court Program? (gc.ca)
  • Did they affect your willingness to stay in the Drug Treatment Court Program? (gc.ca)
  • 10. Has your drug use changed since you've been in the Drug Treatment Court Program? (gc.ca)
  • 11. Did you ever fail a drug test during the Drug Treatment Court Program? (gc.ca)
  • Did this make you more or less willing to stay in the Drug Treatment Court Program? (gc.ca)
  • 12. Has your involvement in criminal activity increased, decreased, or stayed the same since you have been in the Drug Treatment Court Program? (gc.ca)
  • What happened when you committed a crime while in the Drug Treatment Court Program? (gc.ca)
  • 13. What are the best things about the Drug Treatment Court Program? (gc.ca)
  • 14. What things have helped you stay in the Drug Treatment Court Program? (gc.ca)
  • What things have made it hard for you to stay in the Drug Treatment Court Program? (gc.ca)
  • 15. What would you change about the Drug Treatment Court Program to make it better? (gc.ca)
  • 16. Has the Drug Treatment Court Program informed you about other services that could help you? (gc.ca)
  • Results of search for 'su:{Drug evaluation. (who.int)
  • In this respect, I hope that chemists/scientists will get some new guidelines and approaches on screening, evaluation, quality control and standardization of herbal drugs from different chapters of this book. (saujanyabooks.com)
  • Several approaches are currently utilized in the prolongation of the GRT, including floating drug delivery systems (FDDS), also known as hydrodynamically balanced systems (HBS), swelling and expanding systems, polymeric bioadhesive systems, modified-shape systems, high-density systems, and other delayed gastric emptying devices. (scienceopen.com)
  • Approaches to achieving prolonged residence times of the devices in the upper part of the gastrointestinal tract include the use of bioadhesive, size-increasing, and floating drug delivery systems. (scienceopen.com)