Regulatory requirements for the development of commercial products include assessments of potential effects on reproductive function and development of the conceptus. The experimental tests employed in these assessments are complex in design and have numerous experimental end points that require sophisticated methods for their statistical analysis. This manuscript discusses biological and statistical aspects of these data and presents a compilation of methods for their statistical analyses. The discussion includes analyses of maternal toxicity data, estrous cycle data, novel reproductive toxicity end points (germ cell evaluations, hormone levels), and developmental toxicity (teratology) data (fetal malformations or lethality, fetal weight, postnatal evaluations). The suggested methods are offered as tools for assisting scientists in the interpretation of experimental results.
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