The Contribution of Acute Toxicity Testing to the Evaluation of Pharmaceuticals

Front Matter....Pages I-XII
Opening remarks....Pages 1-2
Front Matter....Pages 3-3
Scope of Acute Toxicity Testing — Current Methodology....Pages 5-9
Use of Acute Toxicity Data for Pharmaceuticals....Pages 10-19
Industrial Uses of Acute Toxicity Testing....Pages 20-33
Acute Toxicity Test Data — Has It Any Relevance for the Management of Acute Drug Overdose in man?....Pages 34-41
Acute Toxicology Viewed from the Pharmaceutical Industry....Pages 42-45
In Vitro Models for Acute Toxicity Testing....Pages 46-52
Front Matter....Pages 53-53
EEC/CPMP....Pages 55-59
Appendix....Pages 60-60
Single Dose Toxicity....Pages 61-64
A US/FDA View of Acute Toxicity Testing in the Evaluation of Pharmaceuticals....Pages 65-73
Current Regulatory View of Acute Toxicity Testing in Japan....Pages 74-80
Alternatives to Animals in Toxicological Assessment and Notifications....Pages 81-85
Front Matter....Pages 87-87
Introductory Comments on Ethical Aspects of Acute Toxicity Testing....Pages 89-90
Scientific Constraints on the Use of Acute Toxicity Testing....Pages 91-92
Practical Constraints on the Use of Acute Toxicity Testing....Pages 93-94
Regulatory Constraints on the Use of Acute Toxicity Testing....Pages 95-95
IFPMA — A View on Acute Toxicity Testing in Relation to Pharmaceuticals....Pages 96-98
Closing Remarks....Pages 99-101
Back Matter....Pages 103-104