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Approaching China`s Pharmaceutical Market - Ming Q. Lu
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ISBN: 9783319155753

ID: 9783319155753

A Fundamental Guide to Clinical Drug Development _This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China`s application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China`s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues. Approaching China`s Pharmaceutical Market: _This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China`s application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China`s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues. Arznei - Arzneimittel Medikament Arzneimittel ( Arznei ) Pharmaka Tablette MEDICAL / Pharmacy, Springer-Verlag Gmbh

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ISBN: 9783319155753

[ED: Buch], [PU: Springer-Verlag GmbH], Neuware - This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues., [SC: 0.00], Neuware, gewerbliches Angebot, 241x167x40 mm, [GW: 1115g]

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14

ISBN: 9783319155753

[ED: Buch], [PU: Springer-Verlag GmbH], Neuware - This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues., [SC: 0.00], Neuware, gewerbliches Angebot, 23.5x15.5x cm, [GW: 1154g]

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14, ISBN: 9783319155753

[ED: Buch], [PU: Springer-Verlag GmbH], Neuware - This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues., [SC: 4.50]

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2015, ISBN: 9783319155753

ID: 31518886

A Fundamental Guide to Clinical Drug Development, 1st ed. 2015, Hardcover, Buch, [PU: Springer International Publishing]

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Approaching China`s Pharmaceutical Market
Autor:

Ming Q. Lu

Titel:

Approaching China`s Pharmaceutical Market

ISBN-Nummer:

9783319155753

Detailangaben zum Buch - Approaching China`s Pharmaceutical Market


EAN (ISBN-13): 9783319155753
Gebundene Ausgabe
Erscheinungsjahr: 14
Herausgeber: Springer-Verlag Gmbh

Buch in der Datenbank seit 30.09.2015 22:07:35
Buch zuletzt gefunden am 02.09.2016 08:47:07
ISBN/EAN: 9783319155753

ISBN - alternative Schreibweisen:
978-3-319-15575-3

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