Interpretation of Data
Interpretation of developmental and reproductive toxicity testing data includes:
- Improved understanding of the scientific basis of and regulatory requirements for developmental and reproductive safety evaluation testing such as study designs (including critical periods of sensitivity for developmental and reproductive insults), aspects of study conduct, and data Interpretation of testing drugs in multiple species.
- Interpretation of results from studies, includes the impact of the relationship of exposure of the mother to observations in her offspring including clinical signs, maternal body weight and food consumption, embryo-fetal death, altered growth and structural abnormalities.
- SBH focuses on quality assurance issues relevant to these studies and the extent practical considerations play relative to the results of the studies.