Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review P Zhao, L Zhang, JA Grillo, Q Liu, JM Bullock, YJ Moon, P Song, SS Brar, ... Clinical Pharmacology & Therapeutics 89 (2), 259-267, 2011 | 559 | 2011 |
Predicting drug–drug interactions: an FDA perspective L Zhang, Y Zhang, P Zhao, SM Huang The AAPS journal 11, 300-306, 2009 | 330 | 2009 |
Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK C Wagner, P Zhao, Y Pan, V Hsu, J Grillo, SM Huang, V Sinha CPT: pharmacometrics & systems pharmacology 4 (4), 226-230, 2015 | 301 | 2015 |
The utility of modeling and simulation in drug development and regulatory review SM Huang, DR Abernethy, Y Wang, P Zhao, I Zineh Journal of pharmaceutical sciences 102 (9), 2912-2923, 2013 | 237 | 2013 |
Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions P Zhao, M Rowland, SM Huang Clinical pharmacology & therapeutics 92 (1), 17-20, 2012 | 224 | 2012 |
ITC recommendations for transporter kinetic parameter estimation and translational modeling of transport‐mediated PK and DDIs in humans MJ Zamek‐Gliszczynski, CA Lee, A Poirier, J Bentz, X Chu, H Ellens, ... Clinical Pharmacology & Therapeutics 94 (1), 64-79, 2013 | 223 | 2013 |
FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase–positive non–small cell lung cancer S Khozin, GM Blumenthal, L Zhang, S Tang, M Brower, E Fox, W Helms, ... Clinical cancer research 21 (11), 2436-2439, 2015 | 216 | 2015 |
Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials R Leong, MLT Vieira, P Zhao, Y Mulugeta, CS Lee, SM Huang, ... Clinical Pharmacology & Therapeutics 91 (5), 926-931, 2012 | 189 | 2012 |
Drug interactions evaluation: an integrated part of risk assessment of therapeutics L Zhang, KS Reynolds, P Zhao, SM Huang Toxicology and applied pharmacology 243 (2), 134-145, 2010 | 174 | 2010 |
Selective mitochondrial glutathione depletion by ethanol enhances acetaminophen toxicity in rat liver P Zhao, TF Kalhorn, JT Slattery Hepatology 36 (2), 326-335, 2002 | 157 | 2002 |
Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug … C Wagner, Y Pan, V Hsu, JA Grillo, L Zhang, KS Reynolds, V Sinha, ... Clinical pharmacokinetics 54, 117-127, 2015 | 140 | 2015 |
Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19 AB Ke, SC Nallani, P Zhao, A Rostami‐Hodjegan, JD Unadkat British journal of clinical pharmacology 77 (3), 554-570, 2014 | 122 | 2014 |
Application of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in children XL Jiang, P Zhao, JS Barrett, LJ Lesko, S Schmidt CPT: pharmacometrics & systems pharmacology 2 (10), 1-9, 2013 | 122 | 2013 |
Pharmacometrics in pregnancy: an unmet need AB Ke, A Rostami-Hodjegan, P Zhao, JD Unadkat Annual review of pharmacology and toxicology 54 (1), 53-69, 2014 | 113 | 2014 |
Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation P Zhao, MLT Vieira, JA Grillo, P Song, TC Wu, JH Zheng, V Arya, ... The Journal of Clinical Pharmacology 52 (S1), 91S-108S, 2012 | 108 | 2012 |
A PBPK model to predict disposition of CYP3A‐metabolized drugs in pregnant women: verification and discerning the site of CYP3A induction AB Ke, SC Nallani, P Zhao, A Rostami‐Hodjegan, JD Unadkat CPT: pharmacometrics & systems pharmacology 1 (9), 1-10, 2012 | 103 | 2012 |
Evaluation of Various Static In Vitro–In Vivo Extrapolation Models for Risk Assessment of the CYP3A Inhibition Potential of an Investigational Drug MLT Vieira, B Kirby, I Ragueneau‐Majlessi, A Galetin, JYL Chien, ... Clinical Pharmacology & Therapeutics 95 (2), 189-198, 2014 | 102 | 2014 |
Evaluation of time-dependent inactivation of CYP3A in cryopreserved human hepatocytes P Zhao, KL Kunze, CA Lee Drug metabolism and disposition 33 (6), 853-861, 2005 | 100 | 2005 |
Utility of a physiologically–based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug–drug–disease interaction scenario for rivaroxaban during … JA Grillo, P Zhao, J Bullock, BP Booth, M Lu, K Robie‐Suh, EG Berglund, ... Biopharmaceutics & drug disposition 33 (2), 99-110, 2012 | 99 | 2012 |
Human in vitro glutathionyl and protein adducts of carbamazepine-10, 11-epoxide, a stable and pharmacologically active metabolite of carbamazepine HZ Bu, P Kang, AJ Deese, P Zhao, WF Pool Drug metabolism and disposition 33 (12), 1920-1924, 2005 | 99 | 2005 |