Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency Test

Pan, ZY; Huang, WY; Pan, JH; Koch, G

Pan, ZY (corresponding author), Amgen Inc, 1 Amgen Ctr Dr, Thousand Oaks, CA 91320 USA.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2021; 55 (4): 765

Abstract

The development of biosimilars has substantially increased in recent years. A biosimilar is a biological product which is highly similar to a licensed......

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