The Safety of Medicines Evaluation and Prediction /

Detalles Bibliográficos
Autor principal: Folb, P. I. (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: eBook
Lenguaje:English
Publicado: London : Springer London : Imprint: Springer, 1980.
Edición:1st ed. 1980.
Materias:
Acceso en línea:https://doi.org/10.1007/978-1-4471-3103-8
Tabla de Contenidos:
  • 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.