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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

(Bog, Paperback / softback, Engelsk)
Forfatter: John Geigert
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Forlag: Springer International Publishing AG

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Beskrivelse

In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.

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Alle detaljer

Forlag Springer International Publishing AG
Forfatter John Geigert
Type Bog
Format Paperback / softback
Sprog Engelsk
Udgave Fourth Edition 2023
Udgivelsesdato 16-06-2024
Første udgivelsesår 2024
Illustrationer 1 Illustrations, black and white
Originalsprog Switzerland
Sideantal 573
Indbinding Paperback / softback
Forlag Springer International Publishing AG
Sideoplysninger 573 pages, 1 Illustrations, black and white
Mål 235 x 155
ISBN-13 / EAN-13 9783031319112