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Publications

2012
  • Om Anand, Hassan Almoazen, Nitin Mehrotra, James Johnson, Atul Shukla, Controlled Release of Modified Insulin Glargine from Novel Biodegradable Injectable Gels. AAPS Pharmscitech 2012
  • Nitin Mehrotra, Lisa Tang, Stephanie J Phelps, Bernd Meibohm, Evaluation of Vancomycin Dosing Regimens in Preterm and Term Neonates using Monte-Carlo Simulations. Pharmacotherapy 2012
  • Nitin Mehrotra, Yaning Wang, Venkatesh A. Bhattaram, Justin C. Earp, Jeffry Florian, Christine Garnett, Pravin Jadhav, Kevin Krudys, Joo-Yeon Lee, Fang Li, Jiang Liu, Rajnikanth Madabushi, Anshu Marathe, Christoffer W. Tornoe, Hao Zhu, Jogarao V. Gobburu. Collecting PK data in late phase trials led to alleviating additional trials, drug approval and better dosing. Applied Clinical Trials 2012
  • Liu J, Jadhav PR, Wang Y, and Gobburu J, Improper selection of a pre-specified primary dose-response analysis delays regulatory drug-approval [accepted by The AAPS Journal, 2012 Nov 2]
  • Liu J, Florian J, Birnkrant D, Murray J, Jadhav PR., Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: implications for drug development and clinical decisions. Clin Infect Dis. 2012 Sep;55(5):639-44. Epub 2012 May 31.
  • Liu J, Jadhav PR, Amur S, Fleischer R, Hammerstrom T, Lewis L, Naeger L, O'Rear J, Pacanowski M, Robertson S, Seo S, Soon G, and Birnkrant D., Response Guided Telaprevir Therapy in Prior Relapsers?: The Role of Bridging Data from Treatment-Naïve and Experienced Subjects. Hepatology. 2012 Apr 6. doi: 10.1002/hep.25764
  • Jeffry Florian Jr., Pravin Jadhav, Shashi Amur, Rueben Ayala, Patrick Harrington, Poonam Mishra, Michael Pacanowski, Sarah Robertson, Mary Singer, Greg Soon, Wen Zeng, and Jeffrey Murray. Boceprevir Dosing for Late Responders and Null Responders: The Role of Bridging Data Between Treatment-naive and Experienced Subjects, Hepatology 2012
  • Charles Cooper, ShaAvhree Buckman-Garner, Mary Ann Slack, Jeffry Florian Jr., and Susan McCune. Developing
  • Jeffry Florian Jr., Christine Garnett, Srikanth Nallani, Robert Rappaport, and Douglas Throckmorton. A Modeling and Simulation Approach to Characterize Methadone QT Prolongation Using Pooled Data from Five Clinical Trials in MMT Patients, Clin. Pharmacol. Ther. 2012
  • Yaning Wang, Extracting Knowledge from Failed Development Programmes, Pharmaceutical Medicine, 1 April 2012 - Volume 26 - Issue 2 - pp 91-96
  • Jun Yang, Hong Zhao, Christine Garnett, Atiqur Rahman, Jogarao V Gobburu, William Pierce, Genevieve Schechter, Jeffery Summers, Patricia Keegan, Brian Booth, Yaning Wang, Combination of Exposure-Response and Case-Control Analyses in Regulatory Decision Making, Journal of Clinical Pharmacology, May 1 2012
  • Yaning Wang, Joo Yeon Lee, Theresa Michele, Badrul A Chowdhury, Jogarao V Gobburu, Limitations of model based dose selection for indacaterol in patients with chronic obstructive pulmonary disease, Int J Clin Pharmacol Ther. 2012; 50(9): 622-30
  • Yaning Wang, Joo Yeon Lee, Theresa Michele, Badrul A Chowdhury, Response to comment on the report “Limitations of model-based dose selection for indacaterol in patients with chronic obstructive pulmonary disease”, Int J Clin Pharmacol Ther. 2012; 50(9): 638
  • D. William-Faltaos, Y. Chen, Y. Wang, J. Gobburu and H. Zhu, Quantification of disease progression and dropout for Alzheimer's disease, Int. Journal of Clinical Pharmacology and Therapeutics, 2012
  • Fourie Zirkelbach J, Jackson A, Wang Y, Schuirmann DJ, Use of Partial AUC (PAUC) to Evaluate Bioequivalence – A Case Study with Complex Absorption: Methylphenidate. Pharm Res, September, 2012.
  • Ping Ji, Yaning Wang, Zhihong Li, Chandrahas G Sahajwalla, Regulatory Review of Acetaminophen Clinical Pharmacology in Young Pediatric Patients, Journal of Pharmaceutical Sciences, 2012 Dec;101(12):4383-9.
  • Wang Y, Jadhav PR, Lala M, Gobburu JV, Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies. J Clin Pharmacol 2012 Oct;52(10):1601-6
  • Huang SM, Bhattaram A, Mehrotra N, Wang Y Is This the Dose for You?: The Role of Modeling Clin Pharmacol Ther 2012 Nov 19 [Epub ahead of print]
  • Chen ML, Fourie-Zirkelbach J, Jackson A, Kim S, Lionberger R, Mehta M, Uppoor RS, Wang Y, Yu L, Conner DP, Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release
  • Jing J Fang and Pravin R PR Jadhav, From in vitro EC(50) to in vivo dose-response for antiretrovirals using an HIV disease model. Part II: Application to drug development. Pharmacokinet Biopharm 39(4):369-81 (2012), PMID 22773164
  • Jing J Fang and Pravin R PR Jadhav, From in vitro EC(50) to in vivo dose-response for antiretrovirals using an HIV disease model. Part I: A framework. J Pharmacokinet Biopharm 39(4):357-68 (2012), PMID 22736302
  • Thornton K, Kim G, Maher VE, Chattopadhyay S, Tang S, Moon YJ, Song P, Marathe A, Balakrishnan S, Zhu H, Garnett C, Liu Q, Booth B, Gehrke B, Dorsam RT, Verbois LS, Ghosh D, Wilson W, Duan J, Sarker H, Pope Miksinski S, Skarupa L, Ibrahim A, Justice R, Mu, Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary, Clin Cancer Res, 2012 Jul 15;18(14):3722-30
  • Stockbridge N, Zhang J, Garnett C, Malik M, Practice and challenges of thorough QT studies, J Electrocardiol, 2012 Nov;45(6):582-7
  • Deisseroth A, Kaminskas E, Grillo J, Chen W, Saber H, Lu HL, Rothmann MD, Brar S, Wang J, Garnett C, Bullock J, Burke LB, Rahman A, Sridhara R, Farrell A, Pazdur R, U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis. Clin Cancer Res, 2012 Jun 15;18(12):3212-7
  • Garnett CE, Zhu H, Malik M, Fossa AA, Zhang J, Badilini F, Li J, Darpo B, Sager P, Rodriguez I, Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects. Am Heart J 2012 Jun;163(6):912-30
  • Mehrotra S, Florian J Jr, Gobburu J Don't get boxed in: commentary on the visual inspection practices to assess exposure-response relationships from binary clinical variables. J Clin Pharmacol 2012 Dec;52(12):1912-7
2009
  • Bhattaram VA, Siddiqui O, Kapcala L, Gobburu JV, Endpoints and Analyses to Discern Disease-Modifying Drug Effects in Early Parkinson’s Disease, AAPS J. 1-9 (2009).
  • Jadhav PR, Zhang J, Gobburu JV. Leveraging Prior Knowledge in Guiding Pediatric Drug Development. Pharm. Stat. 2009 Jul (online).
  • Wang Y, Sung C, Dartois C, Ramchandani R, Booth BP, Rock E, Gobburu JV, Tumor Size-Survival Relationship in Non-Small Lung Cancer Patients To Aid Early Clinical Development Decision Making, Clin Pharmacol Ther. 2009 Aug; 86(2):167-74.
2008
  • Garnett CE, Beasley N, Bhattaram VA, Jadhav PR, Madabushi R, Stockbridge N, Tornøe CW, Wang Y, Zhu H, Gobburu JV. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008 Jan; 48(1):13-8.
  • Gobburu J. Disease models. Clin Adv Hematol Oncol. 2008 Apr; 6(4):241-2.
  • Wang Y, Bhattaram VA, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA Pharmacometrics during 2004-2006. J Clin Pharmacol. 2008 Feb; 48(2):146-56.
2007
  • Bhattaram, VA et al. Impact of pharmacometric review on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther. 81, 213-221 (2007).
  • Lesko LJ. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther. 2007 Feb;81(2):170-7. Review.
  • Powell JR, Gobburu JV. Pharmacometrics at FDA: Evolution and Impact on Decisions. Clin Pharmacol Ther. 2007 Jul;82(1):97-102.
  • Tornøe CW, Tworzyanski JJ, Imoisili MA, Alexander JJ, Korth-Bradley JM, Gobburu JV. Optimising piperacillin/tazobactam dosing in paediatrics. Int J Antimicrob Agents. 2007 Oct; 30(4):320-4.
  • Wang, Y. Derivation of various NONMEM estimation methods, J Pharmacokinet Pharmacodyn (2007) 34:575-593.
2005
  • Bhattaram, VA et al. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications. AAPSJ7, E503-E512 (2005).

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