Opinion paper. Resistance to new anti-HIV agents: problems in the pathway of drug registration
Détails
ID Serval
serval:BIB_2618CF0DDCBE
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Opinion paper. Resistance to new anti-HIV agents: problems in the pathway of drug registration
Périodique
Antiviral Therapy
ISSN
1359-6535 (Print)
Statut éditorial
Publié
Date de publication
2005
Volume
10
Numéro
7
Pages
867-72
Notes
Journal Article
Research Support, Non-U.S. Gov't
Research Support, Non-U.S. Gov't
Résumé
Resistance data are now requested by the regulatory agencies as an integral part of the approval process of new antiretroviral drugs. We examined the means by which resistance data was gathered during pre-clinical and clinical Phases I, II and III of drug development, and how the public and academic experts access these proprietary data. The analysis identified various opportunities for improvement of the current process, in particular the need for standards in generating and reporting resistance data on new antiretroviral drugs, and the need to enforce warnings in the product labelling on the drug combinations that can potentially lead to resistance and treatment failure.
Mots-clé
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
Pubmed
Web of science
Création de la notice
25/01/2008 15:45
Dernière modification de la notice
20/08/2019 14:04