The timing of toxicological studies to support clinical trials : proceedings of a CMR discussion meeting held at Nutfield Priory, Nutfield, UK, May 1994 /
Saved in:
| Corporate Author: | |
|---|---|
| Other Authors: | |
| Format: | Book |
| Language: | English |
| Published: |
Dordrecht ; Boston :
Kluwer Academic Publishers,
c1994.
|
| Subjects: |
Table of Contents:
- 1. The application of toxicological investigations in the safe development of medicines / Robert Zerbe
- 2. Review of international recommendations on animal toxicity studies and their relation to clinical exposure / David Scales and Toshimi Usui
- 3. International survey on the timing of toxicity studies in relation to clinical trials / Christopher Parkinson
- 4. Considerations for implementing a toxicity testing strategy / Douglas M. Morton
- 5. Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? - a toxicologist's opinion / Herman Van Cauteren
- 6. Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? - a clinical pharmacologist's opinion / Diane Jorkasky
- 7. The duration of toxicity studies required to support repeated dosing in clinical investigation - a toxicologist's opinion / Toshiji Igarashi.
- 8. The duration of toxicity studies required to support repeated dosing in clinical investigation - a clinician's opinion / John Alexander
- 9. Reproductive and developmental toxicity studies required to support the inclusion of women and children in clinical trials - a toxicologist's opinion / Kurt Suter
- 10. The minimum non-clinical package for initiating Phase I clinical trials / Michael Jackson and Jack Dean
- 11. The duration of toxicity studies to support repeated dosing in clinical investigation / Philip Bentley and Alan Dunton
- 12. The timing of reproductive toxicity studies in relation to clinical trials / Jeanne Manson and Fritz Buhler
- 13. The way forward / Gwyn Morgan
- 14. Input to ICH / R. Michael McClain.