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Evaluation of drug interaction data in prescribing information for NMEs approved in 2000–2004
Author(s) -
Collins C.,
Hachad H.,
Ragueneau I.,
Levy R.
Publication year - 2005
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2004.11.050
Subject(s) - in vivo , pharmacology , drug , pharmacokinetics , clinical pharmacology , drug interaction , in vitro , medicine , drug development , approved drug , chemistry , biochemistry , biology , microbiology and biotechnology
Background The FDA released guidances for in vitro and in vivo drug metabolism/drug interaction studies in 1997 and 1999. This study was undertaken to evaluate the content of labeling information of 74 NMEs approved from 2000 to June 2004 for (i) drug metabolism/drug interaction data, (ii) the occurrence of labeling revisions for pharmacokinetic drug interactions and (iii) any gap between current labeling information and published literature. Methods Labeling information and reviews for NMEs (excluding small molecules, ophthalmic solutions and topical compounds) was accessed at Drugs@FDA . Results Twenty agents (27%) did not include in vitro inhibition data on their labeling. For these 20 agents, seven agents specifically stated that these studies were not performed, 2 agents included in vivo probe data on their labeling, 4 agents included the in vitro data in their review but did not place it in their labeling and for 7 agents, neither in vitro inhibition data or in vivo probe data were discussed in either the labeling or the released portion of their review. No agent was withdrawn for pharmacokinetic interactions. Seven agents (9%) underwent labeling revisions to supplement metabolic data or for pharmacokinetic interactions. Seven agents (9%) had potential interactions identified in the literature that were not addressed in current labeling information. Clinical Pharmacology & Therapeutics (2005) 77 , P12–P12; doi: 10.1016/j.clpt.2004.11.050