BIOSIMILAR DRUG PRODUCT DEVELOPMENT

✍ Scribed by Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow

Publisher: CRC Press
Year: 2017
Tongue: English
Leaves: 496
Series: Drugs and the Pharmaceutical Sciences
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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.

✦ Table of Contents

Content: Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.

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