[Safety assessment of new products developed by the pharmaceutical industry].
Safety assessment of new products developed by the pharmaceutical industry is a scientific, ethical and economic requirement. The finality is an assessment of the benefit/risk ratio of these products, a fundamental issue for their registration. Conventional studies, such as defined by ICH guidelines, and their timing versus clinical trials are reported here. General conditions for management and cost are discussed. Nevertheless, these conventional studies are poorly adapted to current requirements due to insufficient throughput and lack of discriminating potential. Consequently, new tools are being proposed (genomics, proteomics, metabonomics, etc.), allowing, for example, a faster and more relevant screening of leading compounds designed to be administered in humans in clinical trials. Nevertheless, these tools are complex, expensive and probably reserved for the largest companies. A well-balanced approach, including the choice of reasonable objectives, should enable rapid enrichment of our assessment potential, excluding abrupt, unproductive and premature changes.
Claude
J R
JR
Laboratoire de Toxicologie, Faculté des Sciences Pharmaceutiques et Biologiques de l'Université de Paris V, 4, avenue de l'Observatoire F 75006 Paris.
D000818:Animals; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000191:economics / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D004364:Pharmaceutical Preparations / Q000191:economics; D018570:Risk Assessment
D004364:Pharmaceutical Preparations
Les études de sécurité des produits en développement dans l'industrie pharmaceutique.