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Anotace knihy

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This 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 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2), and specification setting (Q6), as well as the latest guideline on Analytical Method Development (Q14), written by subject-matter experts involved in the development and application of the guidelinesAddresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage to forms to, natural products, vaccines, and gene therapy. The book will also address drug-device combination products such as digital drug delivery systems, transdermal systems, inhalation products and nasal spraysPresents detailed treatment of latest statistical approaches (including new approaches to the treatment of validation data method, specification setting and shelf-life prediction)

Parametry knihy

Zařazení knihy Knihy v angličtině Mathematics & science Chemistry Analytical chemistry

• Plný název: Specification of Drug Substances and Products
• Podnázev: Development and Validation of Analytical Methods
• Autor: Christopher M. Riley, Lien Nguyen
• Jazyk: Angličtina
• Vazba: Brožovaná
• EAN: 9780443134661
• ISBN: 0443134669
• ID: 44342139
• Datum vydání: 01. June 2024

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