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Synopsis
An analytical method transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. McGonigle defined Method transfer as “the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed”. The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products.
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About the Author
Vidhi M. Desai, M. Pharm, has completed her M. Pharm in Quality Assurance at S K Patel College of Pharma. Edu. & Res., Ganpat Vidyanagr. Rajesh K. Patel, M.Pharm (Ph.D.) is an Asst. Professor at K J College of Pharmacy, Vadasma. Bhuvan P. Raval, M.Pharm, PGDPRA, MBA, FSAB, (Ph. D.) is an Asst. Professor at K J College of Pharmacy, Vadasma.
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- PublisherLAP LAMBERT Academic Publishing
- Publication date2012
- ISBN 10 3846514713
- ISBN 13 9783846514719
- BindingPaperback
- Number of pages84
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Methodologies for transfer of an analytical method: Quality Assurance
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Methodologies for transfer of an analytical method
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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -An analytical method transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. McGonigle defined Method transfer as the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed . The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products. 84 pp. Englisch. Seller Inventory # 9783846514719
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Methodologies for transfer of an analytical method : Quality Assurance
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Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - An analytical method transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. McGonigle defined Method transfer as the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed . The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products. Seller Inventory # 9783846514719
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Methodologies for transfer of an analytical method
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Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Desai Vidhi M.Vidhi M. Desai, M. Pharm, has completed her M. Pharm in Quality Assurance at S K Patel College of Pharma. Edu. & Res., Ganpat Vidyanagr. Rajesh K. Patel, M.Pharm (Ph.D.) is an Asst. Professor at K J College of Pharmacy,. Seller Inventory # 5495927
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Methodologies for transfer of an analytical method: Quality Assurance
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