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Approaching China's Pharmaceutical Market 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 strat...
| Clasificación: | Libro Electrónico |
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| Autor Corporativo: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cham :
Springer International Publishing : Imprint: Springer,
2015.
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| Edición: | 1st ed. 2015. |
| Temas: | |
| 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.