ABSTRACT
To help drug developers to come to a rational and relevant package of preclinical studies, the European Community’s (EC) Committee on Proprietary Medicinal Products (CPMP) has over the years published a number of guidelines in the various areas of preclinical testing. Guidelines are now available on singledose toxicity (published 1987), repeated-dose toxicity (1983), reproduction studies (1983), testing of medicinal products for their mutagenic potential (1987), carcinogenic potential (1983), pharmacokinetics and metabolic studies in the safety evaluation of new drugs in animals (1983), and preclinical biological safety testing of medicinal products derived from biotechnology (1988).
