Neurobehavioral aspects of developmental toxicity testing.
Tests for detection of neurobehavioral changes in the offspring have been a regulatory requirement in developmental toxicity testing of drugs for almost 20 years. Keeping their purpose of hazard identification and risk assessment for humans in mind, investigators and agency reviewers have become deeply ingrained with some stereotyped behaviors with respect to such relevant issues as choice of animal species and data evaluation. Other problematic areas of study design and conduct, selection of litter representatives for testing, what methods to combine in a testing battery, and statistical treatment of results and their interpretation, will need more research and discussion in the future.
Ulbrich
B
B
Bundesinstitut fur Arzneimittel und Medizinprodukte, Berlin, Germany.
Palmer
A K
AK
D000818:Animals; D001519:Behavior / Q000187:drug effects*; D001522:Behavior, Animal / Q000187:drug effects*; D005314:Embryonic and Fetal Development / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D009420:Nervous System / Q000187:drug effects* / Q000196:embryology / Q000254:growth & development; D009498:Neurotoxins / Q000009:adverse effects*; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D018675:Toxicity Tests / Q000379:methods*
D009498:Neurotoxins