bokomslag Biosimilar Drug Product Development

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496 sidor
2017

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.

Författare: Laszlo Endrenyi, Paul Declerck, Shein-Chung Chow, Laszlo Endrenyi, Shein-Chung Chow
Format: Inbunden
ISBN: 9781498718790
Språk: Engelska
Antal sidor: 496
Utgivningsdatum: 2017-03-07
Förlag: Taylor & Francis Inc