Sinossi
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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L'autore
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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Methodologies for transfer of an analytical method
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LAP LAMBERT Academic Publishing Jun 2012, 2012
ISBN 10: 3846514713
ISBN 13: 9783846514719
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Taschenbuch. Condizione: 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. Codice articolo 9783846514719
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Methodologies for transfer of an analytical method
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LAP LAMBERT Academic Publishing, 2012
ISBN 10: 3846514713
ISBN 13: 9783846514719
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Condizione: 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,. Codice articolo 5495927
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Methodologies for transfer of an analytical method
Editore:
LAP LAMBERT Academic Publishing Jun 2012, 2012
ISBN 10: 3846514713
ISBN 13: 9783846514719
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Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germania
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Taschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. 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.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 84 pp. Englisch. Codice articolo 9783846514719
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Methodologies for transfer of an analytical method : Quality Assurance
Editore:
LAP LAMBERT Academic Publishing, 2012
ISBN 10: 3846514713
ISBN 13: 9783846514719
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Da: AHA-BUCH GmbH, Einbeck, Germania
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Taschenbuch. Condizione: 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. Codice articolo 9783846514719
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Methodologies for transfer of an analytical method: Quality Assurance
Editore:
LAP LAMBERT Academic Publishing, 2012
ISBN 10: 3846514713
ISBN 13: 9783846514719
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