Laszlo Endrenyi,
Shein-Chung Chow,
Dr. Paul Declerck,
. Paul Declerck
e.a.
Biosimilar Drug Product Development
Paperback Engels 2020 1e druk 9780367552497Levertijd ± 11 werkdagen
Gratis verzonden
Samenvatting
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.
Specificaties
Lezersrecensies
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Inhoudsopgave
Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.
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