Development validation analytical methods von riley christopher (25 Ergebnisse)

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Paperback. Zustand: Brand New. 368 pages. 9.25x6.00x0.83 inches. In Stock.

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Taschenbuch. Zustand: Neu. Specification of Drug Substances and Products | Development and Validation of Analytical Methods | Christopher M. Riley (u. a.) | Taschenbuch | Einband - flex.(Paperback) | Englisch | 2020 | Elsevier Inc | EAN 9780081028247 | Verantwortliche Person für die EU: Elsevier B.V., Radarweg 29, 1043 NX AMSTERDAM, NIEDERLANDE, productsafety[at]elsevier[dot]com | Anbieter: preigu.…

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Kartoniert / Broschiert. Zustand: 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.

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Hardcover. Zustand: Good. Good. Dust Jacket NOT present. CD WILL BE MISSING. . SHIPS FROM MULTIPLE LOCATIONS. book.

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paperback. Zustand: New. NEW. SHIPS FROM MULTIPLE LOCATIONS. book.

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.…

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.…