Approaching China's pharmaceutical market : a fundamental guide to clinical drug development /

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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 strat...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Lu, Ming Q. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham, Switzerland : Springer, 2015.
Temas:
Pharmaceutical industry > China.
Drug development > China.
Legislation, Drug
Pharmacy Administration
Drug Discovery
Industrie pharmaceutique > Chine.
Médicaments > Développement > Chine.
BUSINESS & ECONOMICS > Industries > General.
Drug development
Pharmaceutical industry
China
biomedische wetenschappen
biomedicine
farmacologie
pharmacology
Medicine (General)
Geneeskunde (algemeen)
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Preface
  • Law, Regulation and Guidance
  • Pharmaceutical Intellectual Property Rights in China
  • The China Food and Drug Administration (CFDA)
  • Registration
  • Guidance for Application Materials/Booklets (Chemical)
  • New Investigational Drug Application
  • Clinical Development of Investigational New Drug
  • Strategic Drug Development in China and Surrounding Countries
  • Drug Safety Monitoring and Reporting Systems in China
  • In Vitro Diagnostic Development
  • Index.

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