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Technology Transfer: Drug Product Manufacturing Process (AAPS Introductions in the Pharmaceutical Sciences, 10) - Hardcover
- PublisherSpringer
- Publication date2023
- ISBN 10 303132191X
- ISBN 13 9783031321917
- BindingHardcover
- Number of pages162
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Technology Transfer : Drug Product Manufacturing Process
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Technology Transfer: Drug Product Manufacturing Process (AAPS Introductions in the Pharmaceutical Sciences, 10) by Pazhayattil, Ajay Babu, Sharma, Sanjay, Philip, Joe Paul, Gischewski-Silva, Michelle, Ingram, Marzena [Hardcover ]
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Technology Transfer
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Technology Transfer : Drug Product Manufacturing Process
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Technology Transfer : Drug Product Manufacturing Process
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Drug Product Manufacturing Process
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Springer, Berlin|Springer International Publishing|American Association of Pharmaceutical Scientists|Springer, 2023
ISBN 10: 303132191X
ISBN 13: 9783031321917
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Gebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. 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 approac. Seller Inventory # 848651649
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Technology Transfer
Published by
Springer International Publishing Jun 2023, 2023
ISBN 10: 303132191X
ISBN 13: 9783031321917
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Hardcover
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Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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 requirementsof the 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. 164 pp. Englisch. Seller Inventory # 9783031321917
Quantity: 2 available
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Technology Transfer : Drug Product Manufacturing Process
Seller: GreatBookPricesUK, Castle Donington, DERBY, United Kingdom
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Quantity: 5 available
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Technology Transfer: Drug Product Manufacturing Process (AAPS Introductions in the Pharmaceutical Sciences, 10)
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Technology Transfer : Drug Product Manufacturing Process
Published by
Springer International Publishing, 2023
ISBN 10: 303132191X
ISBN 13: 9783031321917
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Hardcover
Seller: AHA-BUCH GmbH, Einbeck, Germany
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Buch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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 requirementsof the 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. Seller Inventory # 9783031321917
Quantity: 1 available