Technology Transfer Drug Product Manufacturing Process /
Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guida...
-д хадгалсан:
| Үндсэн зохиолчид: | , , , , |
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| Байгууллагын зохиогч: | |
| Формат: | Цахим Цахим ном |
| Хэл сонгох: | англи |
| Хэвлэсэн: |
Cham :
Springer International Publishing : Imprint: Springer,
2023.
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| Хэвлэл: | 1st ed. 2023. |
| Цуврал: | AAPS Introductions in the Pharmaceutical Sciences,
10 |
| Нөхцлүүд: | |
| Онлайн хандалт: | https://doi.org/10.1007/978-3-031-32192-4 |
| Шошгууд: |
Шошго нэмэх
Шошго байхгүй, Энэхүү баримтыг шошголох эхний хүн болох!
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| Тойм: | Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements ofthe stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry. |
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| Биет тодорхойлолт: | 1 online resource (XIV, 148 p. 78 illus.). 55 illus. in color. |
| ISBN: | 9783031321924 |
| ISSN: | 2522-8358 ; |
| DOI: | 10.1007/978-3-031-32192-4 |