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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert Fourth Edition 2023 edition
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
John Geigert
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.
| Medios de comunicación | Libros Paperback Book (Libro con tapa blanda y lomo encolado) |
| Publicado | 16 de junio de 2024 |
| ISBN13 | 9783031319112 |
| Editores | Springer International Publishing AG |
| Páginas | 573 |
| Dimensiones | 150 × 220 × 10 mm · 914 g |
| Lengua | Alemán |
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