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Bo Jin

Pfizer Inc.



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Kerry B. Barker

Pfizer Inc.



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505 – Clinical Trial Design IV

On the Similarity of Two Dose-Response Curves

Sponsor: Biopharmaceutical Section
Keywords: Biosimilarity, E-max model, Equivalence

Bo Jin

Pfizer Inc.

Kerry B. Barker

Pfizer Inc.

The 2014 FDA draft guidance of clinical pharmacology data to support a demonstration of biosimilarity to a reference product considers clinical pharmacology studies as a critical part in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.

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