Search Results - "Drug Approval methods"

Determination of the target population in early benefit assessments in Germany: challenges for non-small-cell lung cancer

Authors: ten Thoren, C. Balg, C. Gibbert, J. et al.

Source: Eur J Health Econ

Subject Terms: ddc:610, Original Paper, Lung Neoplasms, Technology Assessment, Biomedical, Databases, Factual, Drug Approval/methods [MeSH], New drugs, Humans [MeSH], Early benefit assessment, I18 (Government Policy-Regulation-Public Health), I10 (General), Lung Neoplasms/epidemiology [MeSH], Target population, NSCLC, Databases, Factual [MeSH], Technology Assessment, Biomedical [MeSH], Germany [MeSH], Antineoplastic Agents/therapeutic use [MeSH], Lung Neoplasms/pathology [MeSH], Non-small-cell lung cancer, Carcinoma, Non-Small-Cell Lung/drug therapy [MeSH], Lung Neoplasms/drug therapy [MeSH], Carcinoma, Non-Small-Cell Lung/epidemiology [MeSH], Antineoplastic Agents, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, Germany, Humans, Drug Approval

Access URL: https://link.springer.com/content/pdf/10.1007/s10198-020-01180-1.pdf
https://pubmed.ncbi.nlm.nih.gov/32236766
https://link.springer.com/article/10.1007/s10198-020-01180-1
https://link.springer.com/content/pdf/10.1007/s10198-020-01180-1.pdf
https://www.ncbi.nlm.nih.gov/pubmed/32236766
https://hdl.handle.net/10419/288418
https://repository.publisso.de/resource/frl:6470598

Opinion paper. Resistance to new anti-HIV agents: problems in the pathway of drug registration

Authors: Dalmau, D. Klimkait, T. Telenti, A.

Subject Terms: Anti-HIV Agents/*pharmacology/therapeutic use Clinical Trials Data Collection/*methods Drug Approval/*methods *Drug Resistance, Multiple, Viral European Union HIV Infections/*drug therapy/*virology HIV-1/drug effects Humans Questionnaires United States United States Food and Drug Administration

Relation: Antiviral Therapy; https://iris.unil.ch/handle/iris/83276; serval:BIB_2618CF0DDCBE; 000233509500011

Availability: https://iris.unil.ch/handle/iris/83276

Pre-clinical study of 21 approved drugs in the mdx mouse

Authors: Carre-Pierrat, M. Lafoux, A. Tanniou, G. et al.

Contributors: Carre-Pierrat, M. Lafoux, A. Tanniou, G. et al.

Source: Neuromuscular Disorders. 21:313-327

Subject Terms: 0301 basic medicine, Muscles/drug effects/pathology, [SDV]Life Sciences [q-bio], Drug Compounding, Preclinical/*methods, Muscle Fibers, Skeletal, Drug Evaluation, Preclinical, In Vitro Techniques, Inbred C57BL, Muscle Fibers, Dose-Response Relationship, Dystrophin, Mice, 03 medical and health sciences, Animals, Muscular Dystrophy, Creatine Kinase, Drug Approval, Skeletal/drug effects/physiology, Dystrophin/genetics, 0303 health sciences, Dose-Response Relationship, Drug, Drug Approval/*methods, Animal, Muscle Contraction/drug effects, Muscles, Inbred mdx, 3. Good health, [SDV] Life Sciences [q-bio], Mice, Inbred C57BL, Muscular Dystrophy, Duchenne, Disease Models, Animal, Duchenne/blood/*drug therapy/pathology, Disease Models, Mice, Inbred mdx, Drug Evaluation, Drug, Creatine Kinase/blood, Muscle Contraction

Access URL: https://pubmed.ncbi.nlm.nih.gov/21392993
http://www.sciencedirect.com/science/article/pii/S0960896611000071
https://europepmc.org/abstract/MED/21392993
https://www.sciencedirect.com/science/article/pii/S0960896611000071
https://www.ncbi.nlm.nih.gov/pubmed/21392993
https://hal.science/hal-02881168v1
https://doi.org/10.1016/j.nmd.2011.01.005

Recommendations for the registration of agents for prevention and treatment of glucocorticoid-induced osteoporosis: an update from the Group for the Respect of Ethics and Excellence in Science

Authors: J. Compston D. M. Reid J. Boisdron et al.

Source: Osteoporosis International, Vol. 19, No 9 (2008) pp. 1247-50
Compston, J, Reid, D M, Boisdron, J, Brandi, M-L, Burlet, N, Cahall, D, Delmas, P D, Dere, W, Devogelaer, J-P, Fitzpatrick, L A, Flamion, B, Goel, N, Korte, S, Laslop, A, Mitlak, B, Ormarsdottir, S, Ringe, J, Rizzoli, R, Tsouderos, Y, Van Staa, T & Reginster, J-Y 2008, 'Recommendations for the registration of agents for prevention and treatment of glucocorticoid-induced osteoporosis: an update from the Group for the Respect of Ethics and Excellence in Science.', Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 19, no. 9. https://doi.org/10.1007/s00198-008-0670-7

Subject Terms: Drug Approval/methods, Male, Bone Density Conservation Agents/therapeutic use, Epidemiology, Glucocorticoids/adverse effects, Biomedische technologie en medicijnen, Sciences de la santé humaine, Osteoporosis/chemically induced/drug therapy/prevention & control, 618.97, Sex Factors, SDG 3 - Good Health and Well-being, Bone Density, Humans, Human health sciences, Drug Approval, Glucocorticoids, Ziekenhuisstructuur en organisatie van de gezondheidszorg, Clinical Trials as Topic, Bone Density Conservation Agents, Farmacie(FARM), Bone Density/drug effects, 3. Good health, Research Design, ddc:618.97, Osteoporosis, Female, Public Health, General & internal medicine, Médecine générale & interne

File Description: application/pdf

Access URL: https://link.springer.com/content/pdf/10.1007%2Fs00198-008-0735-7.pdf
https://pubmed.ncbi.nlm.nih.gov/18604578
https://research-portal.uu.nl/en/publications/98affdff-7827-4efd-8fa5-9158e00ecabe
https://orbi.uliege.be/handle/2268/157329
https://abdn.pure.elsevier.com/en/publications/recommendations-for-the-registration-of-agents-for-prevention-and
https://www.escholar.manchester.ac.uk/uk-ac-man-scw:246627
http://orbi.ulg.ac.be/handle/2268/20324
https://www.ncbi.nlm.nih.gov/pubmed/18604578
https://paperity.org/p/10750310/recommendations-for-the-registration-of-agents-for-prevention-and-treatment-of
https://www.research.manchester.ac.uk/portal/en/publications/recommendations-for-the-registration-of-agents-for-prevention-and-treatment-of-glucocorticoidinduced-osteoporosis-an-update-from-the-group-for-the-respect-of-ethics-and-excellence-in-science(f9349b94-32dc-418c-beba-c33864345028).html
https://archive-ouverte.unige.ch/unige:2679
https://hdl.handle.net/2158/338316

Principles for assessment when approving biosimilar pharmaceuticals / Principer för bedömning vid godkännande av biosimilarer

Authors: Anonymous

Source: Information från Läkemedelsverket. 26(5):8

Evidence-based care for the oldest too, please! / Evidenbaserad vård även för de allra äldsta, tack!

Authors: Langenskiöld, Sophie

Source: Svensk Geriatrik. (1):16

Life Sciences Research to Product Development : Regulatory Requirement Transforming, Volume 1

Authors: Pronobesh Chattopadhyay Danswrang Goyary

Resource Type: eBook.

Subjects: Drug approval--Methods, Clinical trials, Drug development, Drugs--Testing--Standards

Categories: MEDICAL / Pharmacy, SCIENCE / Life Sciences / Botany, SCIENCE / Chemistry / General

New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role / Nye laegemidler og europaeiske godkendelsesprocedurer. The European Agency for the Evaluation of Medicinal Products's rolle

Authors: Ainsworth, M A

Source: Ugeskrift for Laeger. 165(16):1648

Clinical Development : Strategic, Pre-Clinical, and Regulatory Issues

Authors: Janice Steiner

Resource Type: eBook.

Subjects: Drugs--Research--United States, Pharmaceutical industry--United States, Drugs--Law and legislation--United States, Drug Approval--methods

Categories: MEDICAL / Pharmacology, SCIENCE / Chemistry / General

In vivo Pharmacology in Drug Discovery and Development

Authors: Svendsen, Ove Ahnfelt-Rønne, Ian Vanhoutte, Paul

Source: Basic & Clinical Pharmacology & Toxicology. 99:89-90

Subject Terms: Drug Approval - Methods - Statistics & Numerical Data, Clinical Trials, Phase I as Topic, Chemistry, Pharmaceutical, Research, Research - Methods - Trends, 3. Good health, Chemistry, Pharmaceutical - Methods - Trends, 03 medical and health sciences, 0302 clinical medicine, Clinical Trials, Phase I As Topic - Standards - Statistics & Numerical Data, Research Design, Models, Animal, Animals, Humans, Drug Approval

Access URL: https://pubmed.ncbi.nlm.nih.gov/16918707
https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1742-7843.2006.pto_292.x
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1742-7843.2006.pto_292.x
https://www.ncbi.nlm.nih.gov/pubmed/16918707
https://core.ac.uk/display/38002852
https://pubmed.ncbi.nlm.nih.gov/16918707/
http://hub.hku.hk/handle/10722/80275
http://hdl.handle.net/10722/173544

Intelligent Drug Development : Trials and Errors in Clinical Research

Authors: Michael Tansey

Resource Type: eBook.

Subjects: Clinical trials--Ethics, Drug development--Management, Drugs--Testing--Methodology, Clinical trials--Methods, Medical protocols, Drug approval--Methods

Categories: MEDICAL / Pharmacology

International Regulatory Harmonization Amid Globalization of Drug Development : Workshop Summary

Authors: Institute of Medicine Board on Health Sciences Policy Forum on Drug Discovery, Development, and Translation et al.

Resource Type: eBook.

Subjects: Drug approval--Methods, Drugs--Design, Drug development, Drugs--Testing--Standards

Categories: MEDICAL / Allied Health Services / Medical Technology, MEDICAL / Health Policy

Updating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis.

Authors: Smolen, Josef S Boers, Maarten Abadie, Eric C et al.

Contributors: Smolen, Josef S Boers, Maarten Abadie, Eric C et al.

Source: Rheumatology, Vol. 50, no. 10, p. 1732-6 (2011)

Subject Terms: Antirheumatic Agents - therapeutic use, Arthritis, Rheumatoid - drug therapy, physiopathology, Clinical Trials as Topic, Consensus, Control Groups, Drug Approval - methods, Drug and Narcotic Control, Drugs, Investigational, Europe, Humans

Relation: boreal:105543; http://hdl.handle.net/2078.1/105543; info:pmid/21242246

Availability: http://hdl.handle.net/2078.1/105543
https://doi.org/10.1093/rheumatology/keq413

Clinical Trial Methodology

Authors: Karl E. Peace Ding-Geng (Din) Chen

Resource Type: eBook.

Subjects: Clinical trials, Drugs--Testing, Clinical Trials as Topic--methods, Drug Approval--methods, Drug Evaluation--methods, Meta-Analysis as Topic

Categories: MATHEMATICS / Probability & Statistics / General, MEDICAL / Pharmacology, MEDICAL / Pharmacy

Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?

Authors: Ioannidis, J. P.

Source: Philos Ethics Humanit Med
Philosophy, Ethics, and Humanities in Medicine, Vol 3, Iss 1, p 14 (2008)

Subject Terms: Medicine(all), Depressive Disorder, Major, Evidence-Based Medicine, R723-726, Drug Industry, Medical philosophy. Medical ethics, United States Food and Drug Administration, Randomized Controlled Trials as Topic, Review, Antidepressive Agents, United States, Antidepressive Agents/administration & dosage/classification/*therapeutic use, 3. Good health, Depressive Disorder, Major/*drug therapy, Treatment Outcome, Meta-Analysis as Topic, Evidence-Based Medicine/*methods, Humans, Drug Approval/methods/*statistics & numerical data, Drug Approval

Access URL: https://peh-med.biomedcentral.com/track/pdf/10.1186/1747-5341-3-14
https://pubmed.ncbi.nlm.nih.gov/18505564
https://doaj.org/article/21be3568291144a8af8f0be62d7adade
https://www.ncbi.nlm.nih.gov/pubmed/18505564
https://link.springer.com/article/10.1186/1747-5341-3-14
https://pubmed.ncbi.nlm.nih.gov/18505564/
https://peh-med.biomedcentral.com/articles/10.1186/1747-5341-3-14
https://doaj.org/article/21be3568291144a8af8f0be62d7adade
https://link.springer.com/content/pdf/10.1186%2F1747-5341-3-14.pdf
http://olympias.lib.uoi.gr/jspui/handle/123456789/22141

Recommendations for the registration of agents for prevention and treatment of glucocorticoid-induced osteoporosis: an update from the Group for the Respect of Ethics and Excellence in Science

Authors: Compston, J. Reid, D M. Boisdron, J. et al.

Source: ISSN: 0937-941X ; Osteoporosis international, vol. 19, no. 9 (2008) p. 1247-1250.

Subject Terms: info:eu-repo/classification/ddc/618.97, info:eu-repo/classification/ddc/616, Bone Density/drug effects, Bone Density Conservation Agents/therapeutic use, Clinical Trials as Topic, Drug Approval/methods, Female, Glucocorticoids/adverse effects, Humans, Male, Osteoporosis/chemically induced/drug therapy/prevention & control, Research Design, Sex Factors

Relation: info:eu-repo/semantics/altIdentifier/pmid/18604578; unige:2679

Availability: https://archive-ouverte.unige.ch/unige:2679

Opinion paper. Resistance to new anti-HIV agents: problems in the pathway of drug registration

Authors: Dalmau, D. Klimkait, T. Telenti, A.

Source: Antiviral Therapy, vol. 10, no. 7, pp. 867-72

Subject Terms: Anti-HIV Agents/*pharmacology/therapeutic use Clinical Trials Data Collection/*methods Drug Approval/*methods *Drug Resistance, Multiple, Viral European Union HIV Infections/*drug therapy/*virology HIV-1/drug effects Humans Questionnaires United States United States Food and Drug Administration

Relation: info:eu-repo/semantics/altIdentifier/pmid/16312184; info:eu-repo/semantics/altIdentifier/pissn/1359-6535; https://serval.unil.ch/notice/serval:BIB_2618CF0DDCBE

Availability: https://serval.unil.ch/notice/serval:BIB_2618CF0DDCBE

Contact and dialogue between drug companies and the global regulatory authorities throughout a research and development phase / Kontakt og dialog mellem et laegemiddelfirma og de globale registreringsmyndigheder under et forsknings- og udviklingsforlöb

Authors: Kock, M Krogsgaard Thomsen, M

Source: Ugeskrift for Laeger. 165(16):1649

State of the art in benefit-risk analysis: Medicines

Authors: Luteijn, J. M. White, B. C. Gunnlaugsdottir, H. et al.

Contributors: Luteijn, J. M. White, B. C. Gunnlaugsdottir, H. et al.

Source: WOS

Subject Terms: YMAL, Benefit-risk assessment, Health technology assessment, Pharmacovigilance, Drug approval/methods, Risk assessment

File Description: 26-32

Relation: FOOD AND CHEMICAL TOXICOLOGY; 50; 889JL; http://www.julkari.fi/handle/10024/108911; WOS:000300069900004

Availability: http://www.julkari.fi/handle/10024/108911

Updating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis.

Authors: UCL - (SLuc) Service de rhumatologie UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales Smolen, Josef S et al.

Source: Rheumatology, Vol. 50, no. 10, p. 1732-6 (2011)

Index Terms: Antirheumatic Agents - therapeutic use, Arthritis, Rheumatoid - drug therapy, physiopathology, Clinical Trials as Topic, Consensus, Control Groups, Drug Approval - methods, Drug and Narcotic Control, Drugs, Investigational, Europe, Humans, info:eu-repo/semantics/article

URL: http://hdl.handle.net/2078.1/105543