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Rajnikanth Madabushi
Rajnikanth Madabushi
其他姓名Rajanikanth Madabushi, M Rajanikanth, Madabushi R
FDA
在 fda.has.gov 的电子邮件经过验证
标题
引用次数
引用次数
年份
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
5482011
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
2512009
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
2502008
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
2362006
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
1812019
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
1812011
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
1512007
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
982019
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
982012
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
932006
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
872019
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
832008
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
632022
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
622011
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
512008
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
502015
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
492003
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
452014
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
442015
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
392019
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