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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)

Contributor
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
Language
eng
Work
Publication
Extent
1 online resource (X, 345 p. 17 illus., 15 illus. in color.)
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)
Isbn
9783319680774
Instance
Label
Bioequivalence Requirements in Various Global Jurisdictions
Title
Bioequivalence Requirements in Various Global Jurisdictions
Statement of responsibility
edited by Isadore Kanfer
Contributor
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
Is part of
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Kanfer, Isadore
  • SpringerLink (Online service)
Series statement
AAPS Advances in the Pharmaceutical Sciences Series,
Series volume
28
http://library.link/vocab/subjectName
  • Medicine
  • Pharmaceutical technology
Label
Bioequivalence Requirements in Various Global Jurisdictions, edited by Isadore Kanfer, (electronic resource)
Instantiates
Publication
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)
Control code
ssj0001929740
Dimensions
unknown
Extent
1 online resource (X, 345 p. 17 illus., 15 illus. in color.)
Form of item
online
Governing access note
Access restricted to subscribing institutions
Isbn
9783319680774
Isbn Type
(print)
Other control number
10.1007/978-3-319-68078-1
Other physical details
online resource
Specific material designation
remote
System control number
(WaSeSS)ssj0001929740
Label
Bioequivalence Requirements in Various Global Jurisdictions, edited by Isadore Kanfer, (electronic resource)
Publication
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)
Control code
ssj0001929740
Dimensions
unknown
Extent
1 online resource (X, 345 p. 17 illus., 15 illus. in color.)
Form of item
online
Governing access note
Access restricted to subscribing institutions
Isbn
9783319680774
Isbn Type
(print)
Other control number
10.1007/978-3-319-68078-1
Other physical details
online resource
Specific material designation
remote
System control number
(WaSeSS)ssj0001929740

Subject

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