The Timing of Toxicological Studies to Support Clinical Trials Book

	Preface
	Notes on Contributors
1	The application of toxicological investigations in the safe development of medicines	3
2	Review of international recommendations on animal toxicity studies and their relation to clinical exposure	17
3	International survey on the timing of toxicity studies in relation to clinical trials	27
4	Considerations for implementing a toxicity testing strategy	41
5	Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? - a toxicologist's opinion	53
6	Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? - a clinical pharmacologist's opinion	61
7	The duration of toxicity studies required to support repeated dosing in clinical investigation - a toxicologist's opinion	67
8	The duration of toxicity studies required to support repeated dosing in clinical investigation - a clinician's opinion	75
9	Reproductive and developmental toxicity studies required to support the inclusion of women and children in clinical trials - a toxicologist's opinion	85
10	The minimum non-clinical package for initiating Phase I clinical trials	99
11	The duration of toxicity studies to support repeated dosing in clinical investigation	109
12	The timing of reproductive toxicity studies in relation to clinical trials	115
13	The way forward	127
14	Input to ICH	133
	Meeting participants	141
	Glossary	147
	Index	149