Domschke S, Domschke W
Fortschr Med. 1981 Jun 4;99(21):814-8.
According to the new West German drug legislation, new drugs will only be registered if their quality, effectiveness and safety is ensured. Safety means a favourable ratio of therapeutic value and risk of side-effects. Effectiveness can usually be verified most objectively in adequate and well-controlled clinical investigations (phase II and phase III of drug evaluation), which are preceded by pharmacological and toxicological experiments in animals and preliminary pharmakokinetic and pharmakodynamic studies in volunteers (phase I). In phase III and IV, rare but important adverse drug effects are looked for.
