| 书目名称 | The Challenge of CMC Regulatory Compliance for Biopharmaceuticals | | 编辑 | John Geigert | | 视频video | | | 图书封面 |  | | 描述 | "The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceuti | | 出版日期 | Book 2004 | | 关键词 | DNA; Filtration; cell culture; clinical trial; development; drug; drug development; drugs; gene therapy; manu | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4419-9131-7 | | isbn_softcover | 978-1-4613-4804-7 | | isbn_ebook | 978-1-4419-9131-7 | | copyright | Springer Science+Business Media New York 2004 |
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发表于 2025-3-21 19:54:22
