Table of Contents

Section I: Introduction and Presentations.- 1 The application of toxicological investigations in the safe development of medicines.- 2 Review of international recommendations on animal toxicity studies and their relation to clinical exposure.- 3 International survey on the timing of toxicity studies in relation to clinical trials.- 4 Considerations for implementing a toxicity testing strategy.- Section II: Personal Views.- 5 Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? — a toxicologist’s opinion.- 6 Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? — a clinical pharmacologist’s opinion.- 7 The duration of toxicity studies required to support repeated dosing in clinical investigation —a toxicologist’s opinion.- 8 The duration of toxicity studies required to support repeated dosing in clinical investigation — a clinician’s opinion.- 9 Reproductive and developmental toxicity studies required to support the inclusion of women and children in clinical trials — a toxicologist’s opinion.- Section III: Proposals and the Way Forward.- 10 The minimum non-clinical package for initiating Phase I clinical trials.- 11 The duration of toxicity studies to support repeated dosing in clinical investigation.- 12 The timing of reproductive toxicity studies in relation to clinical trials.- The way forward.- 14 Input to ICH.- Meeting participants.