Linked Life Data

8026413

Source:http://linkedlifedata.com/resource/pubmed/id/8026413

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
1994-8-5
pubmed:abstractText
Generic substitution of antiepileptic drugs (AEDs) has been controversial, with many alleged instances of biologic and therapeutic inequivalence reported. The recall of a generic phenytoin (PHT) formulation used in the Veterans Administration (VA) medical system allowed us to evaluate the question of biologic equivalence systematically in a relatively large number of patients at the Bronx VA Medical Center. Serum PHT levels were 22-31% lower during the period of generic intake as compared with levels in the same patients receiving Dilantin. Review of the literature showed only one other adequately documented report of potential clinically significant inequivalence between a brand name and generic AED. Despite the apparent infrequency of generic inequivalence, several areas in which procedures for certification of therapeutic equivalence should be improved were identified.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0013-9580
pubmed:author
pubmed:issnType
Print
pubmed:volume
35
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
656-60
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:articleTitle
Comparative bioavailability of a generic phenytoin and Dilantin.
pubmed:affiliation
Neurology Service, VA Medical Center, Bronx, New York.
pubmed:publicationType
Journal Article, Comparative Study