Linked Life Data

7991647

Source:http://linkedlifedata.com/resource/pubmed/id/7991647

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1-2
pubmed:dateCreated
1995-1-12
pubmed:abstractText
Many countries have established procedures for the introduction of generic pharmaceutical products. In order to protect consumers, these generic products must be demonstrated to be therapeutically equivalent to a previously approved product, typically an innovator product. The therapeutic equivalence of a generic and an innovator product is most commonly based on the demonstration of bioequivalence, i.e. clinically insignificant differences in the rate and extent of drug absorption usually assessed from pharmacokinetic measurements. This article reviews the bioequivalence requirements for generic products and, in the interest of promoting international harmonisation, highlights those areas where differences exist among countries.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0163-7258
pubmed:author
pubmed:issnType
Print
pubmed:volume
62
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
41-55
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:articleTitle
Bioequivalence requirements for generic products.
pubmed:affiliation
School of Pharmacy and Medical Sciences, University of South Australia, Adelaide.
pubmed:publicationType
Journal Article, Review