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A nonclinical safety evaluation program typically includes pharmacology, general toxicity, toxicokinetics, nonclinical PK, reproductive toxicity, genotoxicity, and carcinogenesis. Scientist, Regulatory Strategy. Nonclinical Requirements. Chemistry, Manufacturing, and Controls (CMC) Strategies. Author: Vanessa Atayde, PhD.
FDA prefers the use of DEREK, a knowledge-based expert system for the qualitative prediction of toxicity, and SARAH, a statistical software to identify potentially toxic chemicals for assessment of genotoxic and sensitization potential. Tox Tree and grouping by Cramer rules are starting to lose favor with the FDA. Analytical Instrumentation.
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