Method validation pharmaceutical analysis (60 résultats)

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Taschenbuch. Etat : Neu. TEXT BOOK FOR BIO ANALYTICAL METHOD DEVELOPMENT & VALIDATION | Pharmaceutical Analysis | M. Sumithra (u. a.) | Taschenbuch | Englisch | 2021 | LAP LAMBERT Academic Publishing | EAN 9786204212999 | Verantwortliche Person für die EU: preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, mail[at]preigu[dot]de | Anbieter: preigu. …

Taschenbuch. Etat : Neu. HPLC Method Development and Validation in Pharmaceutical Analysis | Handbook for Analytical Scientists | Ghulam Shabir | Taschenbuch | Einband - flex.(Paperback) | Englisch | 2013 | LAP Lambert Academic Publishing | EAN 9783659321207 | Verantwortliche Person für die EU: OmniScriptum GmbH & Co. KG, Bahnhofstr. 28, 66111 Saarbrücken, info[at]akademikerverlag[dot]de | Anbieter: preigu. …

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Hardcover. Etat : new. Hardcover. New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualificationAnalytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical proceduresMethod selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategyImplementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.…

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Hardback. Etat : New. New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualificationAnalytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical proceduresMethod selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategyImplementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities.…

Buch. Etat : Neu. Neuware -New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification Analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities. 544 pp. Englisch.…

Buch. Etat : Neu. Neuware -New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification Analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities. 544 pp. Englisch.…