The Challenge of CMC Regulatory Compliance for Biopharmaceuticals - John Geigert - Livros - Springer International Publishing AG - 9783031319112 - 16 de junho de 2024
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Fourth Edition 2023 edition

John Geigert

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Fourth Edition 2023 edition

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.


573 pages, 1 Illustrations, black and white; XXXV, 573 p. 1 illus.

Mídia Livros     Paperback Book   (Livro de capa flexível e brochura)
Lançado 16 de junho de 2024
ISBN13 9783031319112
Editoras Springer International Publishing AG
Páginas 573
Dimensões 914 g
Idioma German