title: Preclinical safety assessment: in vitro -- in vivo testing.
abstract: In vitro--and in vivo preclinical safety tests on drug candidates needed before first dose in man and before marketing authorisation are as follows: The acute and repeated dose toxicity studies, the reproductive toxicity studies, the genotoxicity studies, the carcinogenicity studies and finally the safety pharmacology studies. The Safety Assessment of the results with respect to predictability for humans is discussed, as well as new tests under validation. Suggestions for changes in the future of Non-Clinical Safety tests are mentioned.
authors.affiliation: Non-Clinical Safety Research, H. Lundbeck, Valby, Denmark.
authors.forename: F
authors.initials: F
authors.lastname: Højelse
mesh_terms: D000818:Animals; D015197:Carcinogenicity Tests; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006801:Humans; D007928:Lethal Dose 50; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D012098:Reproduction / Q000187:drug effects