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Activity Number: 505
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #315822
Title: On the Similarity of Two Dose-Response Curves
Author(s): Bo Jin* and Kerry Barker
Companies: Pfizer Inc. and Pfizer Inc.
Keywords: Biosimilarity ; E-max model ; Equivalence
Abstract:

The 2014 FDA draft guidance of clinical pharmacology data to support a demonstration of biosimilarity to a reference product considers clinical pharmacology studies as a critical part in the clinical evaluations on similarity between biosimilars and reference products. A particular issue which remains to be unsettled is on the methodology to demonstrate similarity of two dose response curves. Assuming that dose response curve follows an E-max model, we focus on the discussions on the sensitive dose to detect differences and provide a statistical procedure to test the similarity of two dose response curves.

Authors who are presenting talks have a * after their name.

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