Assessment of developmental and reproductive

The studies described herein are considered the most definitive currently available for the assessment of developmental and reproductive hazard. The maternal animals in these studies represent the best and most practical model of the human in terms of complexity. 

Assessment of developmental and reproductive toxicity (DART) is commonly done in rodents (mice and rats) and in rabbits (mainly developmental toxicity). These evaluations use standardized experimental designs described in detail in the respective ICH guidelines (Table 18.1). The entire spectrum of DART... 

Predictive assessment of developmental and reproductive toxicology studies... 

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