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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Perspective on Pharmacokinetic Comparability for Biologics Development
Fei Tang1, Yifei Zhang2, Mohamed Elmeliegy3
1Genentech, Inc., South San Francisco, California, USA.
Abstract:
Comparability assessment of biologics is essential to support manufacturing changes throughout drug development life cycle. Centering on pharmacokinetic comparability for biologics, this manuscript summarizes current and emerging insights drawing from a webinar hosted by the American Society for Clinical Pharmacology and Therapeutics Life Cycle Management Community. The common theme across industry and regulatory experiences is the use of risk-based, hierarchical approaches to bridge pre- and post-change products, ranging from foundational analytical comparability to clinical pharmacokinetic comparability studies.
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