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 reasonably-priced, follow-on/subsequent types of the innovator’s biologic items. yet clinical demanding situations stay as a result of the complexity of either the producing strategy and the buildings of biosimilar products.
Written through a best biostatistics researcher, Biosimilars: layout and research of Follow-on Biologics is the 1st ebook completely dedicated to the statistical layout and research of biosimilarity and interchangeability of biosimilar items. It comprises comparison exams of significant caliber attributes at severe phases of the producing procedures of biologic items.
Connecting the pharmaceutical/biotechnology undefined, executive regulatory firms, and academia, this cutting-edge ebook makes a speciality of the clinical components and functional concerns regarding the layout and research of biosimilar experiences. It covers many of the statistical questions encountered in numerous research designs at varied levels of study 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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