Biosimilar Drug Product Development
Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
ISBN: 9781498718790
Vydavateľstvo: Taylor & Francis
Rok vydania: 2017
Vydanie: 1
Väzba: Hardback
Počet strán: 487
Pôvodná cena: 137,81 €
Výstavná cena:
124,03 €(t.j. po zľave 10%)
(Cena je uvedená vrátane 10% DPH)
Katalógová cena: 105 GBP
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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.