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Añadir al carritoHardcover. Condición: Good. Connecting readers with great books since 1972! Used textbooks may not include companion materials such as access codes, etc. May have some wear or writing/highlighting. We ship orders daily and Customer Service is our top priority!
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Librería: Majestic Books, Hounslow, Reino Unido
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Añadir al carritoCondición: New. pp. 694.
Librería: Books Puddle, New York, NY, Estados Unidos de America
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Añadir al carritoCondición: New. pp. 694 2nd Edition.
Librería: GreatBookPricesUK, Woodford Green, Reino Unido
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Librería: GreatBookPricesUK, Woodford Green, Reino Unido
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Librería: Biblios, Frankfurt am main, HESSE, Alemania
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Librería: Ria Christie Collections, Uxbridge, Reino Unido
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Librería: moluna, Greven, Alemania
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Añadir al carritoCondición: 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.
Idioma: Inglés
Publicado por Elsevier Science & Technology, Elsevier, 2020
ISBN 10: 0081028245 ISBN 13: 9780081028247
Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Alemania
EUR 195,00
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Añadir al carritoTaschenbuch. Condición: 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.
Librería: Revaluation Books, Exeter, Reino Unido
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Añadir al carritoPaperback. Condición: Brand New. 2nd reprint edition. 712 pages. 9.25x7.50x1.38 inches. In Stock. This item is printed on demand.
Idioma: Inglés
Publicado por Elsevier Science & Technology, Elsevier, 2020
ISBN 10: 0081028245 ISBN 13: 9780081028247
Librería: AHA-BUCH GmbH, Einbeck, Alemania
EUR 216,02
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Añadir al carritoTaschenbuch. Condición: 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.