title: Evaluation of safety and tolerance in clinical trials with antimicrobial agents.
abstract: In this review the general and specific difficulties encountered in the evaluation of safety and tolerance of antimicrobial agents in clinical trials are discussed. In addition to the usual pharmacological and toxicological effects (adverse drug reactions) occurring in individual patients, microbiologically induced side-effects also have to be considered. The different methods for registration of side-effects and their limitations are discussed. A system is proposed for evaluation of the cause/effect relationships of adverse drug reactions. A system is also discussed for the evaluation of the severity of adverse drug reactions, and different classifications are presented.
authors.affiliation: Medical Department, Freie Universität Berlin, FRG.
authors.forename: H
authors.initials: H
authors.lastname: Lode
authors.forename: R
authors.initials: R
authors.lastname: Stahlmann
mesh_terms: D000900:Anti-Bacterial Agents; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D004361:Drug Tolerance; D006801:Humans; D010600:Pharmacology
chemical_list: D000900:Anti-Bacterial Agents