Description: Methodologies in Biosimilar Product Development, Hardcover by Lee, Sang Joon (EDT); Chow, Shein-Chung (EDT), ISBN 0367896346, ISBN-13 9780367896348, Brand New, Free shipping in the US "Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, butare not limited to the mix-up use of interval hypotheses testing (., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval"--
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Book Title: Methodologies in Biosimilar Product Development
Publisher: CRC Press LLC
Subject: Clinical Medicine
Publication Year: 2021
Number of Pages: 440 Pages
Publication Name: Methodologies in Biosimilar Product Development
Language: English
Type: Textbook
Subject Area: Medical
Author: Sang Joon Lee, Shein-Chung Chow
Format: Hardcover
