[Problem of the evaluation of experimental research for clinical testing of new drugs in man].
The differences in the implication of animal experimental results for the clinical investigation of drugs are pointed out. Interpretation of experimental data leaves a wide range to discretional decisions. These discretional decisions are tried to be defined as well as the terms "safety of drugs" and the "present state of science" used by legislative authorities. Pharmacological, pharmacokinetic and toxicological investigations are discussed which should be the basis for the first application to man. Moreover, further prerequisites for Phase I of Clinical Pharmacology are mentioned. The present experimental results, the limited number of patients and adaptation of dosage decrease the risk of serious complications to a minimum.
D000818:Animals; D004341:Drug Evaluation; D006801:Humans; D007700:Kinetics; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000378:metabolism; D010600:Pharmacology; D012106:Research; D012306:Risk
D004364:Pharmaceutical Preparations
Problematik der Bewertung experimenteller Voruntersuchungen für die klinische Prüfung neuer Pharmaka am Menschen