The Safety of Medicines

1. Animal testing and early studies in humans.- 1.1. Introduction.- 1.2. Animal investigations.- 1.3. Factors influencing animal data.- 1.4. Extrapolation of data from animals to man.- 1.5. Metabolite-mediated toxicity.- 1.6. Early administration of medicines to man.- 1.7. Summary and conclusions.- 2. Prediction of teratogenic potential of a new medicine.- 2.1. Drug utilisation during pregnancy.- 2.2. The thalidomide model of drug-induced fetal damage.- 2.3. The spectrum of teratogenic effects.- 2.4. Prediction of the teratogenic potential of a new medicine.- 2.5. Decision-taking in practice.- 2.6. Summary and conclusions.- 3. Prediction of dependence-producing potential of a new drug.- 3.1. The features of drug dependence in man.- 3.2. Clinical profiles of drug dependence.- 3.3 Profile of a drug likely to produce dependence.- 3.4. Strategy in evaluation of dependence-potential.- 3.5. Summary and conclusions.- 4. Prediction of carcinogenic potential of a new medicine.- 4.1. The risks of drug-induced neoplasia in man.- 4.2. Profile of the high-risk medicine.- 4.3. Animal studies.- 4.4. Interpretation of animal data.- 4.5. In vitro tests.- 4.6. Summary and conclusions.- 5. The prediction of adverse drug interactions.- 5.1. The incidence and spectrum of drug-drug interactions.- 5.2. Clinically important adverse drug interactions.- 5.3. Prediction of adverse drug interactions.- 5.4. Clinical guidelines.- 5.5. Fixed-ratio combinations.- 5.6. Potential interactions of single-entity medicines.- 5.7. Summary and conclusions.- 6. Monitoring drug safety in clinical practice.- 6.1. Introduction.- 6.2. The diagnosis of adverse drug reactions in practice.- 6.3. Physicians' evaluations of adverse drug reactions.- 6.4. Reporting and monitoring of adverse drug reactions.- 6.5.Risk-benefit evaluations.- 6.6. Summary and conclusions.