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Fritz Scholz:
Approaching China's Pharmaceutical Market : A Fundamental Guide to Clinical Drug Development - libro nuevoISBN: 9783319155760
; PDF; Scientific, Technical and Medical > Industrial chemistry & manufacturing technologies > Industrial c, Springer Berlin Heidelberg
2015
ISBN: 9783319155760
A Fundamental Guide to Clinical Drug Development, 1st ed. 2015, eBook Download (PDF), eBooks, [PU: Springer International Publishing]
ISBN: 9783319155760
Biomedicine; Pharmaceutical Sciences/Technology CFDA, FDA, drug management law, investigational drug, regulatory guidance Books eBook, Springer Nature
2015, ISBN: 9783319155760
A Fundamental Guide to Clinical Drug Development, eBooks, eBook Download (PDF), Auflage, [PU: Springer-Verlag], [ED: 1], Springer-Verlag, 2015
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Detalles del libro - Approaching China's Pharmaceutical Market
EAN (ISBN-13): 9783319155760
Año de publicación: 2015
Editorial: Springer-Verlag
Libro en la base de datos desde 2015-09-30T15:07:36-05:00 (Mexico City)
Página de detalles modificada por última vez el 2023-10-18T17:13:57-06:00 (Mexico City)
ISBN/EAN: 9783319155760
ISBN - escritura alterna:
978-3-319-15576-0
Mode alterno de escritura y términos de búsqueda relacionados:
Autor del libro: ming, fritz springer, schölz schölz, fritz scholz
Título del libro: china and beyond
Datos del la editorial
Autor: Ming Q. Lu
Título: Approaching China's Pharmaceutical Market - A Fundamental Guide to Clinical Drug Development
Editorial: Springer; Springer International Publishing
648 Páginas
Año de publicación: 2015-07-30
Cham; CH
Impreso en
Idioma: Inglés
149,79 € (DE)
154,00 € (AT)
177,00 CHF (CH)
Available
XVI, 648 p. 54 illus., 38 illus. in color.
EA; E107; eBook; Nonbooks, PBS / Technik/Chemische Technik; Medizinische Chemie, Pharmazeutische Chemie; Verstehen; CFDA; FDA; drug management law; investigational drug; regulatory guidance; B; Pharmaceutical Sciences/Technology; Pharmaceutics; Biomedical and Life Sciences; BB
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.
Addresses the key issues for multinational pharmaceutical companies looking to market their drugs in China
Highlights the regulations of the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA (CDE)
Serves as a fundamental guide for clinical research, regulatory, quality control/assurance, and legal departments
Includes supplementary material: sn.pub/extras
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