Search results with tag "Fda expectations for toxicology support of clinical trials"

FDA Expectations for Toxicology Support of Clinical Trials ...

• Impurities B and C must be identified and reported (>0.1%) • Impurity A must also be reported (>0.5%) – use HPLC RT • Impurity B & C – must be evaluated for mutagenicity using “in silico tests” – If positive – do Ames test – If Ames test positive – control as a …

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