How Changes in Quality Might Affect Safety and Efficacy

How Changes in Quality Might Affect Safety and Efficacy 

The type and extent of preclinical and clinical studies should be determined on a case-by-base basis. Establishing comparability among biologic products generally requires a full characterization of physico-chemical properties, identification of impurities, and quantification of biologic activity with both in-vitro and in-vivo testing. Because of the inherent variability of biologic processes, batch-to-batch consistency must also be ensured. If quality attributes (e. g., purity, potency, identity, and stability) cannot be adequately assessed with analytic studies, then preclinical and/or clinical studies will likely be needed. 

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