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(Ebook) Biosimilar Drug Product Development by Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow ISBN 9781498718790, 1498718795

  • SKU: EBN-5756144
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Authors:Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
Pages:487 pages.
Year:2017
Editon:1
Publisher:CRC Press
Language:english
File Size:7.18 MB
Format:pdf
ISBNS:9781498718790, 1498718795
Categories: Ebooks

Product desciption

(Ebook) Biosimilar Drug Product Development by Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow ISBN 9781498718790, 1498718795

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
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