Approaching China's Pharmaceutical Market: A Fundamental Guide to Clinical Drug Development
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Cham [u.a.]
Springer International Publishing
2015
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| Schlagworte: | |
| Online-Zugang: | TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract |
| Beschreibung: | 1 Online-Ressource (XVI, 648 p. 54 illus., 38 illus. in color) |
| ISBN: | 9783319155760 |
| DOI: | 10.1007/978-3-319-15576-0 |
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| 245 | 1 | 0 | |a Approaching China's Pharmaceutical Market |b A Fundamental Guide to Clinical Drug Development |c Ming Q. Lu, ed. |
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| 650 | 4 | |a Biomedicine | |
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| 650 | 4 | |a Medizin | |
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Datensatz im Suchindex
| _version_ | 1804174941274243072 |
|---|---|
| adam_text | APPROACHING CHINA S PHARMACEUTICAL MARKET
/
: 2015
TABLE OF CONTENTS / INHALTSVERZEICHNIS
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
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
APPROACHING CHINA S PHARMACEUTICAL MARKET
/
: 2015
ABSTRACT / INHALTSTEXT
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
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
|
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| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.19 |
| dewey-search | 615.19 |
| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Biologie Medizin |
| doi_str_mv | 10.1007/978-3-319-15576-0 |
| format | Electronic eBook |
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| indexdate | 2024-07-10T07:08:23Z |
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| isbn | 9783319155760 |
| language | English |
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| physical | 1 Online-Ressource (XVI, 648 p. 54 illus., 38 illus. in color) |
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| spelling | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development Ming Q. Lu, ed. Cham [u.a.] Springer International Publishing 2015 1 Online-Ressource (XVI, 648 p. 54 illus., 38 illus. in color) txt rdacontent c rdamedia cr rdacarrier Medicine Pharmaceutical technology Biomedicine Pharmaceutical Sciences/Technology Medizin Lu, Ming Q. Sonstige oth Erscheint auch als Druckausgabe 978-3-319-15575-3 https://doi.org/10.1007/978-3-319-15576-0 Verlag Volltext Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028161117&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028161117&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Abstract |
| spellingShingle | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development Medicine Pharmaceutical technology Biomedicine Pharmaceutical Sciences/Technology Medizin |
| title | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development |
| title_auth | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development |
| title_exact_search | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development |
| title_full | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development Ming Q. Lu, ed. |
| title_fullStr | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development Ming Q. Lu, ed. |
| title_full_unstemmed | Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development Ming Q. Lu, ed. |
| title_short | Approaching China's Pharmaceutical Market |
| title_sort | approaching china s pharmaceutical market a fundamental guide to clinical drug development |
| title_sub | A Fundamental Guide to Clinical Drug Development |
| topic | Medicine Pharmaceutical technology Biomedicine Pharmaceutical Sciences/Technology Medizin |
| topic_facet | Medicine Pharmaceutical technology Biomedicine Pharmaceutical Sciences/Technology Medizin |
| url | https://doi.org/10.1007/978-3-319-15576-0 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028161117&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028161117&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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