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发表于 2019-8-19 07:41:31
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速递书局
| 封面: |
 |
| 题名: |
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals |
| 作者: |
John Geigert |
| 出版社: |
Springer Nature Switzerland AG |
| 出版日期: |
2019-04-25 |
| ISBN: |
Print ISBN 978-3-030-13753-3 Online ISBN 978-3-030-13754-0 |
| 附属页: |
齐全 |
| 书签: |
有 |
| 格式: |
清晰PDF |
| 内容简介: |
This book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. |
| 求助帖链接: |
http://www.expaper.cn/forum.php?mod=viewthread&tid=236586 |
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