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Shiew-Mei Huang
Researcher at Center for Drug Evaluation and Research
Publications - 163
Citations - 9924
Shiew-Mei Huang is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Drug development & Clinical pharmacology. The author has an hindex of 43, co-authored 151 publications receiving 8645 citations. Previous affiliations of Shiew-Mei Huang include Food and Drug Administration.
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Journal ArticleDOI
Membrane transporters in drug development.
Kathleen M. Giacomini,Shiew-Mei Huang,Donald J. Tweedie,Leslie Z. Benet,Kim L. R. Brouwer,Xiaoyan Chu,Amber Dahlin,Raymond Evers,Volker Fischer,Kathleen M. Hillgren,Keith Hoffmaster,Toshihisa Ishikawa,Dietrich Keppler,Richard B. Kim,Caroline A. Lee,Mikko Niemi,Joseph W. Polli,Yuicchi Sugiyama,Peter W. Swaan,Joseph A. Ware,Stephen H. Wright,Sook Wah Yee,Maciej J. Zamek-Gliszczynski,Lei Zhang +23 more
TL;DR: Overall, it is advised that the timing of transporter investigations should be driven by efficacy, safety and clinical trial enrolment questions, 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.
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Evaluation of cytochrome P450 probe substrates commonly used by the pharmaceutical industry to study in vitro drug interactions.
TL;DR: Investigators must consider appropriateness of probe substrates and experimental conditions when conducting in vitro drug interaction studies and when extrapolating the results to in vivo situations.
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Optimizing drug development: strategies to assess drug metabolism/transporter interaction potential--towards a consensus.
TL;DR: This report summarizes the outcomes of a meeting to attempt a consensus on the conduct of in vitro and in vivo studies of metabolic and transport interactions held in Basel in November 2000, under the auspices of the European Federation of Pharmaceutical Sciences, the US Food and Drug Administration and the American Association of pharmaceutical Sciences.
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Predicting drug-drug interactions: an FDA perspective
TL;DR: Critical elements in the in vitro evaluation of drug interaction potential during drug development are summarized and a case study is used to highlight the impact of in vitro information on drug labeling.
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Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.
TL;DR: This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions.