INTEGRATING SAFETY DATA - THE EXPERT REPORT

Complete evaluation of the toxicity of a new chemical entity requires critical analysis of the pattern of positive and negative findings in all types of toxicity tests, pharmacokinetics and metabolism in the sp ecies examined, and correlation of the effects with information about its pharmacodynamic and pharmacological properties. The goal is to obt ain sufficient understanding of the mechanisms underlying the therapeu tic and toxic effects of the compound to permit a well-supported extra polation from the test to the target species. The Expert Report system in the European Community is based on comprehensive 25-page reviews o f information about a compound arranged under 3 headings: Chemistry an d Pharmacy, Pharmacology and Toxicology, and Clinical Studies. Each se ction requires a searching review of the experimental work and the rel evant literature, integration of the findings, and then careful cor-re lation among these 3 main areas of knowledge to indicate the circumsta nces of safe and effective use of the drug.