Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration
Wagner, Christian, Pan, Yuzhuo, Hsu, Vicky, Grillo, Joseph A., Zhang, Lei, Reynolds, Kellie S., Sinha, Vikram, Zhao, Ping
Published in Clinical pharmacokinetics (01.01.2015)
Published in Clinical pharmacokinetics (01.01.2015)
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Journal Article
Clinical Drug–Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access
Rekić, Dinko, Reynolds, Kellie S., Zhao, Ping, Zhang, Lei, Yoshida, Kenta, Sachar, Madhav, Piquette Miller, Micheline, Huang, Shiew-Mei, Zineh, Issam
Published in Journal of pharmaceutical sciences (01.09.2017)
Published in Journal of pharmaceutical sciences (01.09.2017)
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Drug interactions evaluation: An integrated part of risk assessment of therapeutics
Zhang, Lei, Reynolds, Kellie S., Zhao, Ping, Huang, Shiew-Mei
Published in Toxicology and applied pharmacology (01.03.2010)
Published in Toxicology and applied pharmacology (01.03.2010)
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Journal Article
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations
Zhang, Xinyuan, Yang, Yuching, Grimstein, Manuela, Liu, Guansheng, Kitabi, Eliford, Fan, Jianghong, Wang, Ying‐Hong, Earp, Justin, Weaver, James L., Zhu, Hao, Liu, Jiang, Reynolds, Kellie S., Huang, Shiew‐Mei, Wang, Yaning
Published in CPT: Pharmacometrics & Systems Pharmacology (01.09.2021)
Published in CPT: Pharmacometrics & Systems Pharmacology (01.09.2021)
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Web Resource
Quantitative evaluation of pharmacokinetic inhibition of CYP3A substrates by ketoconazole: a simulation study
Zhao, Ping, Ragueneau-Majlessi, Isabelle, Zhang, Lei, Strong, John M, Reynolds, Kellie S, Levy, Rene H, Thummel, Kenneth E, Huang, Shiew-Mei
Published in Journal of clinical pharmacology (01.03.2009)
Published in Journal of clinical pharmacology (01.03.2009)
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Variations in pharmacokinetic-pharmacodynamic target values across MICs and their potential impact on determination of susceptibility test interpretive criteria
Waack, Ursula, Joshi, Abhay, Jang, Seong H, Reynolds, Kellie S
Published in Journal of antimicrobial chemotherapy (11.10.2021)
Published in Journal of antimicrobial chemotherapy (11.10.2021)
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Journal Article
Application of Population Pharmacokinetic Modeling, Exposure-Response Analysis, and Classification and Regression Tree Analysis to Support Dosage Regimen and Therapeutic Drug Monitoring of Plazomicin in Complicated Urinary Tract Infection Patients with Renal Impairment
Zhuang, Luning, Wu, Kunyi, Jang, Seong H, Reynolds, Kellie S, Mishra, Shrimant, Iarikov, Dmitri
Published in Antimicrobial agents and chemotherapy (19.04.2022)
Published in Antimicrobial agents and chemotherapy (19.04.2022)
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Journal Article
Cefiderocol Dosing for Patients Receiving Continuous Renal Replacement Therapy
Wei, Xiaohui, Naseer, Shabnam, Weinstein, Edward A, Iarikov, Dmitri, Nambiar, Sumathi, Reynolds, Kellie S, Jang, Seong H
Published in Clinical pharmacology and therapeutics (01.11.2022)
Published in Clinical pharmacology and therapeutics (01.11.2022)
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Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction
Fan, Jianghong, Yang, Yuching, Grimstein, Manuela, Zhang, Xinyuan, Kitabi, Eliford, Earp, Justin C, Arya, Vikram, Reynolds, Kellie S, Zhu, Hao, Wang, Yaning
Published in Clinical pharmacology and therapeutics (01.03.2022)
Published in Clinical pharmacology and therapeutics (01.03.2022)
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Journal Article
Reply to White et al
Kitabi, Eliford, Bensman, Timothy J, Earp, Justin C, Chilukuri, Dakshina M, Smith, Heidi, Ball, Leslie, O’Shaughnessy, Elizabeth, Yasinskaya, Yuliya, Reynolds, Kellie S
Published in Clinical infectious diseases (25.08.2022)
Published in Clinical infectious diseases (25.08.2022)
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Journal Article
Evaluation of Hemodialysis Effect on Pharmacokinetics of Meropenem/Vaborbactam in End-Stage Renal Disease Patients Using Modeling and Simulation
Zhuang, Luning, Yu, Yichao, Wei, Xiaohui, Florian, Jeffry, Jang, Seong H, Reynolds, Kellie S, Wang, Yaning
Published in Journal of clinical pharmacology (01.08.2020)
Published in Journal of clinical pharmacology (01.08.2020)
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Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria
Kitabi, Eliford, Bensman, Timothy J, Earp, Justin C, Chilukuri, Dakshina M, Smith, Heidi, Ball, Leslie, O’Shaughnessy, Elizabeth, Yasinskaya, Yuliya, Colangelo, Philip M, Reynolds, Kellie S
Published in Clinical infectious diseases (07.09.2021)
Published in Clinical infectious diseases (07.09.2021)
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Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
Sahre, Martina D, Milligan, Lauren, Madabushi, Rajanikanth, Graham, Richard A, Reynolds, Kellie S, Terzic, Andre, Benjamin, Jessica, Burckart, Gilbert J, Huang, Shiew-Mei, Schuck, Robert, Thompson, Aliza M, Zineh, Issam
Published in Clinical pharmacology and therapeutics (01.08.2021)
Published in Clinical pharmacology and therapeutics (01.08.2021)
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Journal Article
A Comprehensive Updated Review on SARS-CoV-2 and COVID-19
Ren, Yunzhao R, Golding, Amit, Sorbello, Alfred, Ji, Ping, Chen, Jianmeng, Saluja, Bhawana, Witzmann, Kimberly, Arya, Vikram, Reynolds, Kellie S, Choi, Su-Young, Nikolov, Nikolay P, Sahajwalla, Chandrahas
Published in Journal of clinical pharmacology (01.08.2020)
Published in Journal of clinical pharmacology (01.08.2020)
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Developing and Using Therapeutics for Emerging Infections
McCune, Jeannine S, Reynolds, Kellie S
Published in Clinical pharmacology and therapeutics (01.10.2015)
Published in Clinical pharmacology and therapeutics (01.10.2015)
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New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process
Huang, Shiew-Mei, Strong, John M, Zhang, Lei, Reynolds, Kellie S, Nallani, Srikanth, Temple, Robert, Abraham, Sophia, Habet, Sayed Al, Baweja, Raman K, Burckart, Gilbert J, Chung, Sang, Colangelo, Philip, Frucht, David, Green, Martin D, Hepp, Paul, Karnaukhova, Elena, Ko, Hon-Sum, Lee, Jang-Ik, Marroum, Patrick J, Norden, Janet M, Qiu, Wei, Rahman, Atiqur, Sobel, Solomon, Stifano, Toni, Thummel, Kenneth, Wei, Xiao-Xiong, Yasuda, Sally, Zheng, Jenny H, Zhao, Hong, Lesko, Lawrence J
Published in Journal of clinical pharmacology (01.06.2008)
Published in Journal of clinical pharmacology (01.06.2008)
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Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation
Zhao, Ping, Vieira, Manuela de L T, Grillo, Joseph A, Song, Pengfei, Wu, Ta-Chen, Zheng, Jenny H, Arya, Vikram, Berglund, Eva Gil, Atkinson, Jr, Arthur J, Sugiyama, Yuichi, Pang, K Sandy, Reynolds, Kellie S, Abernethy, Darrell R, Zhang, Lei, Lesko, Lawrence J, Huang, Shiew-Mei
Published in Journal of clinical pharmacology (01.01.2012)
Published in Journal of clinical pharmacology (01.01.2012)
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Are literature references sufficient for dose recommendations? An FDA case study of efavirenz and rifampin
DiGiacinto, Jennifer L, Chan-Tack, Kirk M, Robertson, Sarah M, Reynolds, Kellie S, Struble, Kimberly A
Published in Journal of clinical pharmacology (01.04.2008)
Published in Journal of clinical pharmacology (01.04.2008)
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