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Bowen Tang
PTC Therapeutics Inc, South Plainfield, New Jersey, United States of America
Publications
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Review Article
Drug Transporters: Regulatory Guidance from ICH, USFDA, EMA and PMDA
Author(s): Bowen Tang* and Vijay More
Drug transporters play a critical role in disposition of xenobiotics, and altered transport function could lead to adverse effects. Given their importance in drug-drug interactions, regulatory agencies recommend testing transporter inhibitory potential for all investigational drugs. Based on route of elimination and target organ, agencies also recommend evaluating if investigational drugs are substrates for major transporters. This review compares guidance from United States (USFDA), European Union (EMA), Japanese (PMDA) and International Council for Harmonization (ICH) pertinent to drug transporters... View more»