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Combination Drug Products - Siegel
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Combination Drug Products - nouveau livre

2013, ISBN: 9780470050941

[ED: Buch], [PU: John Wiley & Sons], Neuware - A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination… Plus…

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A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step… Plus…

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Development and Approval of Combination Products - edition reliée, livre de poche

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Hardback, [PU: John Wiley & Sons Inc], A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug d… Plus…

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Combination Drug Products - edition reliée, livre de poche

2008, ISBN: 0470050942

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Development and Approval of Combination Products - edition reliée, livre de poche

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Development and Approval of Combination Products: A Regulatory Perspective

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

Informations détaillées sur le livre - Development and Approval of Combination Products: A Regulatory Perspective


EAN (ISBN-13): 9780470050941
ISBN (ISBN-10): 0470050942
Version reliée
Date de parution: 2008
Editeur: John Wiley & Sons
215 Pages
Poids: 0,517 kg
Langue: eng/Englisch

Livre dans la base de données depuis 2008-06-04T01:00:03+02:00 (Paris)
Page de détail modifiée en dernier sur 2021-10-24T18:06:41+02:00 (Paris)
ISBN/EAN: 9780470050941

ISBN - Autres types d'écriture:
0-470-05094-2, 978-0-470-05094-1
Autres types d'écriture et termes associés:
Auteur du livre: siegel evan, john wiley sons
Titre du livre: products


Données de l'éditeur

Auteur: Evan B. Siegel
Titre: Development and Approval of Combination Products - A Regulatory Perspective
Editeur: John Wiley & Sons
216 Pages
Date de parution: 2008-06-05
Poids: 0,517 kg
Langue: Anglais
115,00 € (DE)
No longer receiving updates
161mm x 240mm x 19mm

BB; Hardcover, Softcover / Chemie; Medizinische Chemie, Pharmazeutische Chemie; Apparatetechnik u. Biosensoren; Arzneimittelentwicklung; Bioinstrumentation & Biosensors; Biomedical Engineering; Biomedizintechnik; Chemie; Chemistry; Drug Discovery & Development; Medical Science; Medizin; Pharmacology & Pharmaceutical Medicine; Pharmakologie u. Pharmazeutische Medizin; Wirkstoffforschung u. -entwicklung; Apparatetechnik u. Biosensoren; Wirkstoffforschung u. -entwicklung; Pharmakologie u. Pharmazeutische Medizin

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

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