Abstract
ABSTRACT The Non‐Clinical Evaluation Subcommittee of the Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA) collected historical control data from developmental and reproductive toxicity studies, which were conducted by the member companies and associated contract laboratories between 1986 and 1993. The data include spontaneous incidences of fetal morphological alterations and other observations made at terminal cesarean sections in rats, rabbits and mice. In addition, mating and natural delivery data in rats are also provided. There were strain differences as well as inter‐laboratory variations in the incidences of fetal visceral and skeletal alterations for both rats and rabbits. These inter‐laboratory variations were attributed to differences in the selection of observation parameters, observation criteria and classification of the findings.
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