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Biosimilars - Design and Analysis of Follow-on Biologics (Hardcover)
Loot Price: R4,014
Discovery Miles 40 140
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Biosimilars - Design and Analysis of Follow-on Biologics (Hardcover)
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As many biological products face losing their patents in the next
decade, the pharmaceutical industry needs an abbreviated regulatory
pathway for approval of biosimilar drug products, which are
cost-effective, follow-on/subsequent versions of the innovator's
biologic products. But scientific challenges remain due to the
complexity of both the manufacturing process and the structures of
biosimilar products. Written by a top biostatistics researcher,
Biosimilars: Design and Analysis of Follow-on Biologics 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. Connecting the pharmaceutical/biotechnology industry,
government regulatory agencies, and academia, this state-of-the-art
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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