Safety assessment of new products developed by the pharmaceutical industry
Claude, J.R.
Annales Pharmaceutiques Francaises 59(5): 324-330
2001
ISSN/ISBN: 0003-4509 PMID: 11787426 Document Number: 538545
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.