The Resource Bioequivalence Requirements in Various Global Jurisdictions, edited by Isadore Kanfer, (electronic resource)

Bioequivalence Requirements in Various Global Jurisdictions, edited by Isadore Kanfer, (electronic resource)

Label
Bioequivalence Requirements in Various Global Jurisdictions
Title
Bioequivalence Requirements in Various Global Jurisdictions
Statement of responsibility
edited by Isadore Kanfer
Contributor
Editor
Provider
Subject
Language
eng
Summary
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products
Member of
Image bit depth
0
LC call number
  • RS380
  • RS190-210
Literary form
non fiction
http://library.link/vocab/relatedWorkOrContributorName
  • Kanfer, Isadore.
  • SpringerLink
Series statement
AAPS Advances in the Pharmaceutical Sciences Series,
Series volume
28
http://library.link/vocab/subjectName
  • Medicine
  • Pharmaceutical technology
  • Biomedicine
  • Pharmaceutical Sciences/Technology
Label
Bioequivalence Requirements in Various Global Jurisdictions, edited by Isadore Kanfer, (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
Brazil -- Canada -- China -- The European Union -- India -- Bioequivalence Studies in Japan -- Middle East and North Africa (MENA) Bioequivalence Requirements -- Russia -- South Africa -- The United States of America -- World Health Organization (WHO)
Dimensions
unknown
Extent
X, 345 p. 17 illus., 15 illus. in color.
File format
multiple file formats
Form of item
electronic
Isbn
9783319680781
Level of compression
uncompressed
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
10.1007/978-3-319-68078-1
Other physical details
online resource.
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
(DE-He213)978-3-319-68078-1
Label
Bioequivalence Requirements in Various Global Jurisdictions, edited by Isadore Kanfer, (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
Brazil -- Canada -- China -- The European Union -- India -- Bioequivalence Studies in Japan -- Middle East and North Africa (MENA) Bioequivalence Requirements -- Russia -- South Africa -- The United States of America -- World Health Organization (WHO)
Dimensions
unknown
Extent
X, 345 p. 17 illus., 15 illus. in color.
File format
multiple file formats
Form of item
electronic
Isbn
9783319680781
Level of compression
uncompressed
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
10.1007/978-3-319-68078-1
Other physical details
online resource.
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
(DE-He213)978-3-319-68078-1

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