Statistical tests for detecting reference product change in biosimilar studies

Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstract: For the biosimilarity assessment between a test product and a reference product, the US Food and Drug Administration (FDA) recommends a stepwise approach for obtaining totality-of-the-evidence in support of regulatory approval of the submission. The stepwise […]

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