Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy
Sinha, V, Zhao, P, Huang, S M, Zineh, I
Published in Clinical pharmacology and therapeutics (01.05.2014)
Published in Clinical pharmacology and therapeutics (01.05.2014)
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Journal Article
Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5
Yoshida, K, Sun, B, Zhang, L, Zhao, P, Abernethy, DR, Nolin, TD, Rostami‐Hodjegan, A, Zineh, I, Huang, S‐M
Published in Clinical pharmacology and therapeutics (01.07.2016)
Published in Clinical pharmacology and therapeutics (01.07.2016)
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Journal Article
Next-generation medicines: past regulatory experience and considerations for the future
Pacanowski, M A, Leptak, C, Zineh, I
Published in Clinical pharmacology and therapeutics (01.03.2014)
Published in Clinical pharmacology and therapeutics (01.03.2014)
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Journal Article
PBPK model describes the effects of comedication and genetic polymorphism on systemic exposure of drugs that undergo multiple clearance pathways
Vieira, M D L T, Kim, M-J, Apparaju, S, Sinha, V, Zineh, I, Huang, S-M, Zhao, P
Published in Clinical pharmacology and therapeutics (01.05.2014)
Published in Clinical pharmacology and therapeutics (01.05.2014)
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Journal Article
The pharmacogenetics research network: from SNP discovery to clinical drug response
Giacomini, K M, Brett, C M, Altman, R B, Benowitz, N L, Dolan, M E, Flockhart, D A, Johnson, J A, Hayes, D F, Klein, T, Krauss, R M, Kroetz, D L, McLeod, H L, Nguyen, A T, Ratain, M J, Relling, M V, Reus, V, Roden, D M, Schaefer, C A, Shuldiner, A R, Skaar, T, Tantisira, K, Tyndale, R F, Wang, L, Weinshilboum, R M, Weiss, S T, Zineh, I
Published in Clinical pharmacology and therapeutics (01.03.2007)
Published in Clinical pharmacology and therapeutics (01.03.2007)
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Journal Article
Cytochrome P4502D6 (CYP2D6) gene locus heterogeneity: characterization of gene duplication events
Gaedigk, A, Ndjountché, L, Divakaran, K, Dianne Bradford, L, Zineh, I, Oberlander, T F, Brousseau, D C, McCarver, D G, Johnson, J A, Alander, S W, Wayne Riggs, K, Steven Leeder, J
Published in Clinical pharmacology and therapeutics (01.02.2007)
Published in Clinical pharmacology and therapeutics (01.02.2007)
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Journal Article
Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development
Thway, T. M., Wang, Y. M., Booth, B. P., Maxfield, K., Huang, S. M., Zineh, I.
Published in The AAPS journal (19.12.2019)
Published in The AAPS journal (19.12.2019)
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Journal Article
Improving the tools of clinical pharmacology: Goals for 2017 and beyond
Zineh, I, Abernethy, D, Hop, Ceca, Bello, A, McClellan, M B, Daniel, G W, Romine, M H
Published in Clinical pharmacology and therapeutics (01.01.2017)
Published in Clinical pharmacology and therapeutics (01.01.2017)
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Journal Article
Office of clinical pharmacology science day: a forum to stimulate innovation in clinical pharmacology
Owen, R P, Jain, L, Zhang, L, Zineh, I
Published in Clinical pharmacology and therapeutics (01.06.2013)
Published in Clinical pharmacology and therapeutics (01.06.2013)
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Journal Article
Influence of phenotype and pharmacokinetics on beta-blocker drug target pharmacogenetics
Beitelshees, A L, Zineh, I, Yarandi, H N, Pauly, D F, Johnson, J A
Published in The pharmacogenomics journal (01.05.2006)
Published in The pharmacogenomics journal (01.05.2006)
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Journal Article
Pharmacogenetics and Coumarin Dosing — Recalibrating Expectations
Zineh, Issam, Pacanowski, Michael, Woodcock, Janet
Published in The New England journal of medicine (12.12.2013)
Published in The New England journal of medicine (12.12.2013)
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Journal Article
The Utility of Modeling and Simulation in Drug Development and Regulatory Review
Huang, Shiew-Mei, Abernethy, Darrell R., Wang, Yaning, Zhao, Ping, Zineh, Issam
Published in Journal of pharmaceutical sciences (01.09.2013)
Published in Journal of pharmaceutical sciences (01.09.2013)
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Journal Article
Transporters in Drug Development: Scientific and Regulatory Considerations
Zhang, Lei, Huang, Shiew-Mei, Reynolds, Kellie, Madabushi, Rajanikanth, Zineh, Issam
Published in Clinical pharmacology and therapeutics (01.11.2018)
Published in Clinical pharmacology and therapeutics (01.11.2018)
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Journal Article
Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective
Drozda, Katarzyna, Pacanowski, Michael A, Grimstein, Christian, Zineh, Issam
Published in JACC. Basic to translational science (01.08.2018)
Published in JACC. Basic to translational science (01.08.2018)
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Journal Article