Methodologies in Biosimilar Product Development

Author	: Sang Joon Lee
Publisher	: CRC Press
Total Pages	: 393
Release	: 2021-09-30
ISBN-10	: 9781000451917
ISBN-13	: 1000451917
Rating	: 4/5 (917 Downloads)

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Book Synopsis Methodologies in Biosimilar Product Development by : Sang Joon Lee

Download or read book Methodologies in Biosimilar Product Development written by Sang Joon Lee and published by CRC Press. This book was released on 2021-09-30 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time.

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