The Safety of Medicines
Evaluation and Prediction
Erschienen am 6. Dezember 2012
XII, 106 Seiten
978-1-4471-3103-8 (ISBN)
Beschreibung
The last thirty years have seen an unprecedented increase in the discovery of new drugs, and moreover, these drugs, unlike many of the nostra of former times, have varied and powerful pharmacological actions. The occurrence of one or two "drug disasters", together with a change in public attitudes, has made it necessary for governments to introduce legislation to control the intro duction and release of new therapeutic agents, and most countries in the Western World have some form of drug licensing agency. Whole series of regulations have appeared which aim at discovering and defining the toxicity of new drugs. Many of these regulations rely heavily on testing drugs in animals before they are used in man, and at present very extensive and prolonged animal studies are required by most licensing authorities. It is most opportune that Professor Folb has decided to review the present position in this monograph. It is not only inhumane but also wasteful of time and money if extensive animal experiments which have little or no relevance to the human situation are carried out; furthermore, such results may even be dangerously misleading. There is little doubt that some preliminary animal investigations are necessary, but it is essential to keep their relevance under continuous review and to adopt a critical and flexible approach rather than heap regulation upon regulation.
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Inhalt
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.
