Toxicity data Chemical Safety Summaries

In summary, in studies of chemical toxicity, pathways and rates of metabolism as well as effects resulting from toxicokinetic factors and receptor affinities are critical in the choice of the animal species and experimental design. Therefore it is important that the animal species chosen as a model for humans in safety evaluations metabolize the test chemical by the same routes as humans and, furthermore, that quantitative differences are considered in the interpretation of animal toxicity data. Risk assessment methods involving the extrapolation of toxic or carcinogenic potential of a chemical from one species to another must consider the metabolic and toxicokinetic characteristics of both species. 

BA (and related toxicity) issues are addressed in the physical-chemical characterizations of the API, the solid-state form of the API (rationale for selection and comparative physical-chemical characteristics), particle size controls and/or dissolution data for solid oral and suspension dosage forms. Other safety issues concern purity and impurities of the API and drug product. Within the NDA, the batch-tracking summary table compares the impurity profile during development up to and including material produced by the registration process... 

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