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Biosimilars: Design and Analysis of Follow-on Biologics
Paperback
Medical ReferenceProbability & Statistics
ISBN13: 9780367379728
Publisher: CRC Press
Published: Oct 23 2019
Pages: 444
Weight: 1.37
Height: 0.90 Width: 6.14 Depth: 9.21
Language: English
Written by a top biostatistics researcher, this is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. The book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
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