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Anbieter: Biblios, Frankfurt am main, HESSE, Deutschland
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Anbieter: preigu, Osnabrück, Deutschland
Taschenbuch. Zustand: Neu. Specification of Drug Substances and Products | Development and Validation of Analytical Methods | Christopher M. Riley (u. a.) | Taschenbuch | Einband - fest (Hardcover) | Englisch | 2020 | Elsevier Inc | EAN 9780081028247 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu.
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Anbieter: moluna, Greven, Deutschland
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In den WarenkorbZustand: New. Presents a critical assessment of the application of ICH guidelines on method validation and specification settingWritten by subject-matter experts involved in the development and application of the guidelinesProvides a comprehensi.
Anbieter: GreatBookPricesUK, Woodford Green, Vereinigtes Königreich
EUR 326,29
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EUR 317,35
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In den WarenkorbZustand: New. Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non.
Sprache: Englisch
Verlag: Elsevier - Health Sciences Division Sep 2024, 2024
ISBN 10: 0443134669 ISBN 13: 9780443134661
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Taschenbuch. Zustand: Neu. Neuware - Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the second edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.
Sprache: Englisch
Verlag: Elsevier Science & Technology, Elsevier, 2020
ISBN 10: 0081028245 ISBN 13: 9780081028247
Anbieter: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Deutschland
Taschenbuch. Zustand: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Englisch.
Anbieter: Brook Bookstore On Demand, Napoli, NA, Italien
EUR 211,12
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In den WarenkorbZustand: new. Questo è un articolo print on demand.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 198,80
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In den WarenkorbPaperback. Zustand: Brand New. 2nd reprint edition. 712 pages. 9.25x7.50x1.38 inches. In Stock. This item is printed on demand.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 251,83
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In den WarenkorbPaperback. Zustand: Brand New. 3rd edition. 894 pages. 11.00x8.75x1.50 inches. In Stock. This item is printed on demand.
Sprache: Englisch
Verlag: Elsevier Science & Technology, Elsevier, 2020
ISBN 10: 0081028245 ISBN 13: 9780081028247
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Taschenbuch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.