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Biosimilar Drug Product Development

Drugs and the Pharmaceutical Sciences

Format: Hardback
Publisher: Taylor & Francis Inc, Portland, United States
Imprint: Productivity Press
Published: 7th Mar 2017
Dimensions: w 158mm h 241mm d 33mm
Weight: 904g
ISBN-10: 1498718795
ISBN-13: 9781498718790
Barcode No: 9781498718790
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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.

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