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 within your means, follow-on/subsequent types of the innovator’s biologic items. yet clinical demanding situations stay as a result complexity of either the producing strategy and the constructions of biosimilar products.
Written via a most sensible biostatistics researcher, Biosimilars: layout and research of Follow-on Biologics is the 1st ebook fullyyt dedicated to the statistical layout and research of biosimilarity and interchangeability of biosimilar items. It contains comparison checks of vital caliber attributes at serious levels of the producing strategies of biologic items.
Connecting the pharmaceutical/biotechnology undefined, executive regulatory organisations, and academia, this state of the art ebook specializes in the clinical elements and useful concerns regarding the layout and research of biosimilar experiences. It covers lots of the statistical questions encountered in numerous research designs at diverse levels of analysis and improvement of organic items.
Read Online or Download Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series) PDF
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