The Safety of Medicines Evaluation and Prediction - Folb, P. I.; SpringerLink (Online service) (London : Springer London : Imprint: Springer, 1980)
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.
Keywords: Pharmacology; Internal medicine; Pharmacy; Pharmacology/Toxicology.; Internal Medicine; Pharmacy