Téléchargez le livre : Specification of Drug Substances and Products

Specification of Drug Substances and Products

Development and Validation of Analytical Methods

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Elsevier


Paru le : 2024-09-22



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Description
Specification of Drug Substances and Drug Products 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) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions. - Addresses 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 forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combinationproducts such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).
Pages
1190 pages
Collection
n.c
Parution
2024-09-22
Marque
Elsevier
EAN papier
9780443134661
EAN PDF
9780443134678
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
0
Taille du fichier
20949 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
253,20 €
EAN EPUB SANS DRM
9780443134678
Informations sur l'ebook
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
253,20 €

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