Concentration‐QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review CE Garnett, N Beasley, VA Bhattaram, PR Jadhav, R Madabushi, ... The Journal of Clinical Pharmacology 48 (1), 13-18, 2008 | 245 | 2008 |
Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies J Chen, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, ... Gastroenterology 144 (7), 1450-1455. e2, 2013 | 216 | 2013 |
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008 JY Lee, CE Garnett, JVS Gobburu, VA Bhattaram, S Brar, JC Earp, ... Clinical pharmacokinetics 50, 627-635, 2011 | 175 | 2011 |
Pediatric antihypertensive trial failures: analysis of end points and dose range DK Benjamin Jr, PB Smith, P Jadhav, JV Gobburu, MD Murphy, ... Hypertension 51 (4), 834-840, 2008 | 136 | 2008 |
Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies Y Wang, P Jadhav, M Lala, J Gobburu Journal of clinical pharmacology 52 (10), 1601, 2012 | 120 | 2012 |
Determination of celecoxib in pharmaceutical formulations using UV spectrophotometry and liquid chromatography RN Saha, C Sajeev, PR Jadhav, SP Patil, N Srinivasan Journal of Pharmaceutical and Biomedical Analysis 28 (3-4), 741-751, 2002 | 87 | 2002 |
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004–2006 Y Wang, AV Bhattaram, PR Jadhav, LJ Lesko, R Madabushi, JR Powell, ... The Journal of Clinical Pharmacology 48 (2), 146-156, 2008 | 83 | 2008 |
Innovation at the intersection of clinical trials and real‐world data science to advance patient care B Swift, L Jain, C White, V Chandrasekaran, A Bhandari, DA Hughes, ... Clinical and translational science 11 (5), 450-460, 2018 | 67 | 2018 |
Determination of flurbiprofen in pharmaceutical formulations by UV spectrophotometry and liquid chromatography C Sajeev, PR Jadhav, D RaviShankar, RN Saha Analytica Chimica Acta 463 (2), 207-217, 2002 | 66 | 2002 |
A proposal for scientific framework enabling specific population drug dosing recommendations PR Jadhav, J Cook, V Sinha, P Zhao, A Rostami‐Hodjegan, ... The Journal of Clinical Pharmacology 55 (10), 1073-1078, 2015 | 50 | 2015 |
Reporting guidelines for population pharmacokinetic analyses K Dykstra, N Mehrotra, CW Tornøe, H Kastrissios, B Patel, N Al-Huniti, ... Journal of pharmacokinetics and pharmacodynamics 42, 301-314, 2015 | 48 | 2015 |
A new equivalence based metric for predictive check to qualify mixed-effects models PR Jadhav, JVS Gobburu The AAPS journal 7, E523-E531, 2005 | 46 | 2005 |
Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study PR Jadhav, J Zhang, JVS Gobburu Pharmaceutical Statistics: The Journal of Applied Statistics in the …, 2009 | 38 | 2009 |
The need for modeling and simulation to design clinical investigations in children PR Jadhav, SE Kern The Journal of Clinical Pharmacology 50 (S9), 121S-129S, 2010 | 32 | 2010 |
Rapid and sensitive spectrofluorimetric method for the estimation of celecoxib and flurbiprofen S Chandran, P Jadhav, P Kharwade, R Saha Indian journal of pharmaceutical sciences 68 (1), 2006 | 30 | 2006 |
Evaluation of model‐based prediction of pharmacokinetics in the renal impairment population KL Yee, M Li, T Cabalu, V Sahasrabudhe, J Lin, P Zhao, P Jadhav The Journal of Clinical Pharmacology 58 (3), 364-376, 2018 | 21 | 2018 |
Semi-mechanistic pharmacodynamic modeling for degarelix, a novel gonadotropin releasing hormone (GnRH) blocker PR Jadhav, H Agersø, CW Tornøe, JVS Gobburu Journal of pharmacokinetics and pharmacodynamics 33, 609-634, 2006 | 21 | 2006 |
Response‐guided telaprevir therapy in prior relapsers? The role of bridging data from treatment‐naïve and experienced subjects J Liu, PR Jadhav, S Amur, R Fleischer, T Hammerstrom, L Lewis, ... Hepatology 57 (3), 897-902, 2013 | 18 | 2013 |
Utility of model‐based approaches for informing dosing recommendations in specific populations: report from the public AAPS Workshop IR Younis, J Robert Powell, A Rostami‐Hodjegan, B Corrigan, ... The Journal of Clinical Pharmacology 57 (1), 105-109, 2017 | 17 | 2017 |
Harnessing the potential of emerging digital health and biological sampling technologies for clinical drug development: promise to reality PA Kothare, PR Jadhav, P Gupta, JC Harrelson, L Dickmann Clinical Pharmacology & Therapeutics 104 (6), 1125-1135, 2018 | 15 | 2018 |