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Biosimilar Drug Product Development

Laszlo Endrenyi • Shein-Chung Chow • Paul Declerck

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496 sidor
2020

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, Shein-Chung Chow, Paul Declerck
Format: Pocket/Paperback
ISBN: 9780367552497
Språk: Engelska
Antal sidor: 496
Utgivningsdatum: 2020-06-30
Förlag: CRC Press