By Shein-Chung Chow
As many organic items face wasting their patents within the subsequent decade, the pharmaceutical wishes an abbreviated regulatory pathway for approval of biosimilar drug items, that are in your price range, follow-on/subsequent types of the innovator’s biologic items. yet clinical demanding situations stay a result of complexity of either the producing method and the constructions of biosimilar products.
Written through a most sensible biostatistics researcher, Biosimilars: layout and research of Follow-on Biologics is the 1st booklet totally dedicated to the statistical layout and research of biosimilarity and interchangeability of biosimilar items. It contains comparison checks of significant caliber attributes at serious phases of the producing strategies of biologic items.
Connecting the pharmaceutical/biotechnology undefined, executive regulatory organizations, and academia, this cutting-edge ebook specializes in the medical elements and useful concerns on the topic of the layout and research of biosimilar stories. It covers lots of the statistical questions encountered in quite a few research designs at varied phases of analysis and improvement of organic items.
Read or Download Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series) PDF
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