The Timing of Toxicological Studies to Support Clinical Trials
Over the past twelve years, the Centre for Medicines Research has held a series of Workshops on a number of topics related to the drug discovery and development process. The major objective of these Workshops has been to provide an international forum for regula tory, academic and industry represen...
| Other Authors: | , , , |
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| Format: | eBook |
| Language: | English |
| Published: |
Dordrecht
Springer Netherlands
1994, 1994
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| Edition: | 1st ed. 1994 |
| Subjects: | |
| Online Access: | |
| Collection: | Springer Book Archives -2004 - Collection details see MPG.ReNa |
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