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Safety of biotechnological products
1European Medicines Evaluation Agency, Unit for the Evaluation of Medicinal Products for Human Use, Canary Wharf, London, UK.
Pharmacology & Toxicology
|July 25, 2000
Abstract:
The safety of biotechnological products used for medicinal products is addressed by EU council directives. The general principles and the regulatory framework for the handling of new drug applications within this areas are described both with respect to benefit/risk evaluation, quality assessment, preclinical safety and efficacy testing.