[An ocular toxicity study with flupirtine as an example of evaluation of possible ocular drug side effects in human volunteers (author's transl)].
Animal experiments do not provide complete information on all the possible ocular side effects and the toxicity of a new drug. Several functional or dynamic parameters of vision can only be tested in humans as they are either do not exist in laboratory animals or their assessment requires a subjective contribution by the test person. A study was carried out on a new analgesic substance (Flupirtine) in which a large number of such parameters were tested in young healthy volunteers. The results were subjected to statistical analysis with a two-factor partlyhierarchical anova and no toxic effects were detected. The study shows how such parameters of visual function can be tested in humans.
D000328:Adult; D000631:Aminopyridines / Q000009:adverse effects*; D000700:Analgesics / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005123:Eye / Q000187:drug effects*; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male
D000631:Aminopyridines; D000700:Analgesics; C034161:flupirtine
Die Bewertung möglicher Arzneimettelneben-wirkungen am Auge im Probandenversuch. Darstellung am Beispiel einer Okulotoxizitätsstudie mit Flupirtine.