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 resting battery, and statistical treatment of results and their interpretation, will need more research and discussion in the future.
Developmental aspects of neurobehavioral toxicity / Bignami, G; Laviola, G; Alleva, E; Cagiano, R; Lacomba, C; Cuomo, Vincenzo. - In: TOXICOLOGY LETTERS. - ISSN 0378-4274. - STAMPA. - 64/65:(1992), pp. 231-237. [10.2307/3432662]
Developmental aspects of neurobehavioral toxicity
CUOMO, VINCENZO
1992
Abstract
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 resting battery, and statistical treatment of results and their interpretation, will need more research and discussion in the future.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
