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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the

Barbara M Davit1, Mei-Ling Chen, Dale P Conner

  • 1Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Metro Park North One, Rockville, Maryland 20855, USA. barbara.davit@fda.hhs.gov

The AAPS Journal
|September 14, 2012
PubMed

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