Requirements of preclinical examinations.
The eye is an important and sensitive target organ not only for ophthalmic drugs but also generally for adverse drug effects and has to be taken into consideration accordingly when performing toxicological studies. Depending on the drug in question protocols for oculotoxicity studies have to be determined on a case by case basis. The test battery used to detect possible eye damage should be an intelligent combination of pharmacokinetic/metabolic studies, clinical examinations, pathomorphologic examinations, and biochemical tests. For special studies on oculotoxicity only pigmented animals should be used. The legal basis for the necessity to conduct oculotoxicity studies and ophthalmologic examinations in toxicity studies is given by national law (AMG) and guidelines and by EEC-Guidelines. Studies have to be performed according to the principles of Good Laboratory Praxis.
Lehnert
T
T
Institut für Arzneimittel des Bundesgesundheitsamts Berlin, Germany.
Ulbrich
B
B
D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D004361:Drug Tolerance; D005062:European Union; D005858:Germany; D009883:Ophthalmic Solutions / Q000633:toxicity*
D009883:Ophthalmic Solutions