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 | 548 | 2011 |
Sorafenib for the treatment of unresectable hepatocellular carcinoma RC Kane, AT Farrell, R Madabushi, B Booth, S Chattopadhyay, ... The oncologist 14 (1), 95-100, 2009 | 251 | 2009 |
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 | 250 | 2008 |
Hyperforin in St. John’s wort drug interactions R Madabushi, B Frank, B Drewelow, H Derendorf, V Butterweck European journal of clinical pharmacology 62, 225-233, 2006 | 236 | 2006 |
Model‐informed drug development: current US regulatory practice and future considerations Y Wang, H Zhu, R Madabushi, Q Liu, SM Huang, I Zineh Clinical Pharmacology & Therapeutics 105 (4), 899-911, 2019 | 181 | 2019 |
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 | 181 | 2011 |
Impact of pharmacometric reviews on new drug approval and labeling decisions—a survey of 31 new drug applications submitted between 2005 and 2006 VA Bhattaram, C Bonapace, DM Chilukuri, JZ Duan, C Garnett, ... Clinical Pharmacology & Therapeutics 81 (2), 213-221, 2007 | 151 | 2007 |
Model‐informed drug discovery and development: current industry good practice and regulatory expectations and future perspectives S Marshall, R Madabushi, E Manolis, K Krudys, A Staab, K Dykstra, ... CPT: pharmacometrics & systems pharmacology 8 (2), 87-96, 2019 | 98 | 2019 |
Clinical pharmacology basis of deriving dosing recommendations for dabigatran in patients with severe renal impairment S Hariharan, R Madabushi The Journal of Clinical Pharmacology 52 (S1), 119S-125S, 2012 | 98 | 2012 |
Once-daily tobramycin in cystic fibrosis: better for clinical outcome than thrice-daily tobramycin but more resistance development? O Burkhardt, C Lehmann, R Madabushi, V Kumar, H Derendorf, T Welte Journal of Antimicrobial Chemotherapy 58 (4), 822-829, 2006 | 93 | 2006 |
Liver microphysiological systems for predicting and evaluating drug effects AJS Ribeiro, X Yang, V Patel, R Madabushi, DG Strauss Clinical Pharmacology & Therapeutics 106 (1), 139-147, 2019 | 87 | 2019 |
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 |
Role of model-informed drug development approaches in the lifecycle of drug development and regulatory decision-making R Madabushi, P Seo, L Zhao, M Tegenge, H Zhu Pharmaceutical Research 39 (8), 1669-1680, 2022 | 63 | 2022 |
Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics R Madabushi, DS Cox, M Hossain, DA Boyle, BR Patel, G Young, ... The Journal of Clinical Pharmacology 51 (1), 19-28, 2011 | 62 | 2011 |
Population pharmacodynamic model of bronchodilator response to inhaled albuterol in children and adults with asthma K Blake, R Madabushi, H Derendorf, J Lima Chest 134 (5), 981-989, 2008 | 51 | 2008 |
Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative TD Nolin, GR Aronoff, WH Fissell, L Jain, R Madabushi, K Reynolds, ... Clinical Journal of the American Society of Nephrology 10 (1), 159-164, 2015 | 50 | 2015 |
An HPLC‐MS method for simultaneous estimation of α,β‐arteether and its metabolite dihydroartemisinin, in rat plasma for application to pharmacokinetic study M Rajanikanth, KP Madhusudanan, RC Gupta Biomedical chromatography 17 (7), 440-446, 2003 | 49 | 2003 |
Effectiveness of clopidogrel dose escalation to normalize active metabolite exposure and antiplatelet effects in CYP2C19 poor metabolizers RB Horenstein, R Madabushi, I Zineh, LM Yerges‐Armstrong, CJ Peer, ... The Journal of Clinical Pharmacology 54 (8), 865-873, 2014 | 45 | 2014 |
Personalized cardiovascular medicine today: a food and drug administration/center for drug evaluation and research perspective A Blaus, R Madabushi, M Pacanowski, M Rose, RN Schuck, ... Circulation 132 (15), 1425-1432, 2015 | 44 | 2015 |
Emerging role of organ‐on‐a‐chip technologies in quantitative clinical pharmacology evaluation N Isoherranen, R Madabushi, SM Huang Clinical and translational science 12 (2), 113-121, 2019 | 39 | 2019 |