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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

Author

W. Mai

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Review Sep 2026

A Proposal for the Use of an Innovative Two-Stage PK-Clinical Adaptive Trial in Biosimilar Product Development

For approval of biosimilar drug products, the United States Food and Drug Administration (FDA) recommends a stepwise approach for obtaining the totality-of-the evidence for demonstration of the biosimilarity between a proposed biosimilar product and its reference (innovative) product. The stepwise approach consists of...

W. Mai, Shein-Chung Chow · 0 citations

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