The Resource Approaching China's Pharmaceutical Market : A Fundamental Guide to Clinical Drug Development, edited by Ming Q. Lu, (electronic resource)

Approaching China's Pharmaceutical Market : A Fundamental Guide to Clinical Drug Development, edited by Ming Q. Lu, (electronic resource)

Label
Approaching China's Pharmaceutical Market : A Fundamental Guide to Clinical Drug Development
Title
Approaching China's Pharmaceutical Market
Title remainder
A Fundamental Guide to Clinical Drug Development
Statement of responsibility
edited by Ming Q. Lu
Contributor
Editor
Provider
Subject
Language
eng
Summary
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
Image bit depth
0
LC call number
  • RS380
  • RS190-210
Literary form
non fiction
http://library.link/vocab/relatedWorkOrContributorName
  • Lu, Ming Q.
  • SpringerLink
http://library.link/vocab/subjectName
  • Medicine
  • Pharmaceutical technology
  • Biomedicine
  • Pharmaceutical Sciences/Technology
Label
Approaching China's Pharmaceutical Market : A Fundamental Guide to Clinical Drug Development, edited by Ming Q. Lu, (electronic resource)
Instantiates
Publication
Antecedent source
mixed
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
not applicable
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
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
Dimensions
unknown
Extent
XVI, 648 p. 54 illus., 38 illus. in color.
File format
multiple file formats
Form of item
electronic
Isbn
9783319155760
Level of compression
uncompressed
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
10.1007/978-3-319-15576-0
Other physical details
online resource.
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
(DE-He213)978-3-319-15576-0
Label
Approaching China's Pharmaceutical Market : A Fundamental Guide to Clinical Drug Development, edited by Ming Q. Lu, (electronic resource)
Publication
Antecedent source
mixed
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
not applicable
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
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
Dimensions
unknown
Extent
XVI, 648 p. 54 illus., 38 illus. in color.
File format
multiple file formats
Form of item
electronic
Isbn
9783319155760
Level of compression
uncompressed
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
10.1007/978-3-319-15576-0
Other physical details
online resource.
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
(DE-He213)978-3-319-15576-0

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