[Comprehension of the side effect profile of a new substance under development. Experimental toxicological aspects].

The detection of undesirable side effects takes place at several stages in the development of a drug. For this purpose all important endpoints such as acute toxicity, local tolerance, allergenicity, genotoxicity, subchronic/chronic toxicity and reproduction toxicity (male and female fertility, teratogenicity, peri- and postnatal studies) serve to establish the major toxicological characteristics. Comparative metabolism studies are carried out in order to optimize the extrapolation of the results obtained in animal experiments to humans. Special, non-routine studies must be adopted for testing cephalosporins and quinolones. Examples of these are provided.