. .
Français
France
Livres similaires
Autres livres qui pourraient ressembler au livre recherché:
Outils de recherche
s'inscrire

Connectez-vous avec Facebook:

S'inscrire
Mot de passe oublié?


Historique de recherche
Liste pense-bête
Liens vers eurolivre.fr

Partager ce livre sur…
Livre conseillé
Actualités
Conseils d'eurolivre.fr
Publicité
FILTRE
- 0 Résultats
prix le plus bas: 69,90 €, prix le plus élevé: 94,50 €, prix moyen: 84,06 €
Development and Approval of Combination Products: A Regulatory Perspective
Livre non disponible
(*)

Development and Approval of Combination Products: A Regulatory Perspective - edition reliée, livre de poche

2008, ISBN: 0470050942, Lieferbar binnen 4-6 Wochen Frais d'envoiVersandkostenfrei innerhalb der BRD

ID: 9780470050941

Internationaler Buchtitel. In englischer Sprache. Verlag: John Wiley & Sons, 215 Seiten, L=242mm, B=156mm, H=19mm, Gew.=517gr, [GR: 16990 - HC/Pharmazie/Pharmakologie/Toxikologie], [SW: - Consumer Health], Gebunden, Klappentext: 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. 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.

Nouveaux livres DEU
Buchgeier.com
Lieferbar binnen 4-6 Wochen (Besorgungstitel) Frais d'envoiVersandkostenfrei innerhalb der BRD
Details...
(*) Livre non disponible signifie que le livre est actuellement pas disponible à l'une des plates-formes associées nous recherche.
Development and Approval of Combination Products: A Regulatory Perspective - Evan B. Siegel
Livre non disponible
(*)

Evan B. Siegel:

Development and Approval of Combination Products: A Regulatory Perspective - edition reliée, livre de poche

ISBN: 9780470050941

ID: 9780470050941

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. 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. Consumer Health HEALTH & FITNESS / Safety MEDICAL / Pharmacology, JOHN WILEY & SONS INC

Nouveaux livres Rheinberg-Buch.de
Buch, Englisch, Neuware Frais d'envoiAb 20¤ Versandkostenfrei in Deutschland, Sofort lieferbar, DE. (EUR 0.00)
Details...
(*) Livre non disponible signifie que le livre est actuellement pas disponible à l'une des plates-formes associées nous recherche.
Development and Approval of Combination Products: A Regulatory Perspective - Evan B. Siegel (Editor)
Livre non disponible
(*)
Evan B. Siegel (Editor):
Development and Approval of Combination Products: A Regulatory Perspective - nouveau livre

ISBN: 9780470050941

A step-by-step, integrated approach for successful, FDA-approved combination drug productsUsing 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 productsApproaches to clinical trial protocol design and executionChemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination productsKey sponsor/FDA meetings and negotiations essential for approval and commercializationCase 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. Textbooks New Books ~~ Medicine~~ Pharmacology Development-and-Approval-of-Combination-Products~~Evan-B-Siegel Wiley 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.

Nouveaux livres [USA] Barnesandnoble.com
Free Shipping on eligible orders over $25 Frais d'envoiLivraison non-comprise
Details...
(*) Livre non disponible signifie que le livre est actuellement pas disponible à l'une des plates-formes associées nous recherche.
Development and Approval of Combination Products - Siegel, Evan B.
Livre non disponible
(*)
Siegel, Evan B.:
Development and Approval of Combination Products - nouveau livre

2008, ISBN: 9780470050941

ID: 1622391&WAN=10022&WBT=28664&WMID=W000000443

2008. 216 p. 24 cm ; GEB ; Development and Approval of Combination The book covers combination drug product development in preclinical, clinical, and manufacturing stages and ties these perspectives together with a regulatory underpinning that leads to successful product development and FDA approval. It describes the modern, integrated approach to drug-device, biologic-device, drug-drug, and biologic-biologic product development. It presents the basic regulatory principles of combination products, and reviews manufacturing and controls; preclinical testing models; pharmacology; clinical testing; and regulatory submissions, FDA review, and approvals. This is a key reference for professionals involved in developing or regulating combination medical products.A step-by-step, integrated approach for successful, FDA-approved combination drug productsUsing 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 aspe cts of manufacturing controls and validation that lead to stable components for combination products Key sponsor/FDA meetings and negotiations essential for approval and commercializationCase 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. Buch gebund. Buch

Nouveaux livres Zeilenreich.de
Zeilenreich.de
Bestellungen mit Buch sind portofrei. Frais d'envoiLivraison non-comprise
Details...
(*) Livre non disponible signifie que le livre est actuellement pas disponible à l'une des plates-formes associées nous recherche.

< Retour aux résultats de recherche...
Détails sur le livre
Development and Approval of Combination Products: A Regulatory Perspective
Auteur:

Evan B. Siegel

Titre:

Development and Approval of Combination Products: A Regulatory Perspective

ISBN:

9780470050941

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 04.06.2008 01:00:03
Livre trouvé récemment le 28.07.2016 02:18:11
ISBN/EAN: 9780470050941

ISBN - Autres types d'écriture:
0-470-05094-2, 978-0-470-05094-1

< Retour aux résultats de recherche...
< pour archiver...
Livres en relation