Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2010-3-1
pubmed:abstractText
Membrane transporters can be major determinants of the pharmacokinetic, safety and efficacy profiles of drugs. This presents several key questions for drug development, including which transporters are clinically important in drug absorption and disposition, and which in vitro methods are suitable for studying drug interactions with these transporters. In addition, what criteria should trigger follow-up clinical studies, and which clinical studies should be conducted if needed. In this article, we provide the recommendations of the International Transporter Consortium on these issues, and present decision trees that are intended to help guide clinical studies on the currently recognized most important drug transporter interactions. The recommendations are generally intended to support clinical development and filing of a new drug application. Overall, it is advised that the timing of transporter investigations should be driven by efficacy, safety and clinical trial enrolment questions (for example, exclusion and inclusion criteria), as well as a need for further understanding of the absorption, distribution, metabolism and excretion properties of the drug molecule, and information required for drug labelling.
pubmed:grant
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
1474-1784
pubmed:author
pubmed-author:BenetLeslie ZLZ, pubmed-author:BrouwerKim L RKL, pubmed-author:ChuXiaoyanX, pubmed-author:DahlinAmberA, pubmed-author:EversRaymondR, pubmed-author:FischerVolkerV, pubmed-author:GiacominiKathleen MKM, pubmed-author:HillgrenKathleen MKM, pubmed-author:HoffmasterKeith AKA, pubmed-author:HuangShiew-MeiSM, pubmed-author:International Transporter Consortium, pubmed-author:IshikawaToshihisaT, pubmed-author:KepplerDietrichD, pubmed-author:KimRichard BRB, pubmed-author:LeeCaroline ACA, pubmed-author:NiemiMikkoM, pubmed-author:PolliJoseph WJW, pubmed-author:SugiyamaYuichiY, pubmed-author:SwaanPeter WPW, pubmed-author:TweedieDonald JDJ, pubmed-author:WareJoseph AJA, pubmed-author:WrightStephen HSH, pubmed-author:YeeSook WahSW, pubmed-author:Zamek-GliszczynskiMaciej JMJ, pubmed-author:ZhangLeiL
pubmed:issnType
Electronic
pubmed:volume
9
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
215-36
pubmed:dateRevised
2011-9-26
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Membrane transporters in drug development.
pubmed:publicationType
Journal Article, Research Support, U.S. Gov't, Non-P.H.S., Review, Research Support, N.I.H., Extramural