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Jogarao Gobburu

Research Profile

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United States

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Physiology

Pharmacokinetics

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Pharmacology, Clinical

Chemicals & Drugs

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Publications

TOP 3
Islam Rasem Younis; Thomas Laughren; Mitchell Mathis; Yaning Wang; Jogarao V S Gobburu
An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia.
Jiang Liu; Yaning Wang; Pravin R Jadhav; Jogarao V S Gobburu
Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval.
Jun Yang; Hong Zhao; Brian Booth; Christine Garnett; Jogarao V S Gobburu; Patricia Keegan; William Pierce; Atiqur Rahman; Genevieve Schechter; Jeffery Summers; Yaning Wang
The combination of exposure-response and case-control analyses in regulatory decision making.

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All Publications

2013: Islam Rasem Younis; Thomas Laughren; Mitchell Mathis; Yaning Wang; Jogarao V S Gobburu
An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia.
Journal of clinical psychopharmacology 2013;33(2):152-6.
2013: Jiang Liu; Yaning Wang; Pravin R Jadhav; Jogarao V S Gobburu
Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval.
The AAPS journal 2013;15(2):407-14.
2013: Jun Yang; Hong Zhao; Brian Booth; Christine Garnett; Jogarao V S Gobburu; Patricia Keegan; William Pierce; Atiqur Rahman; Genevieve Schechter; Jeffery Summers; Yaning Wang
The combination of exposure-response and case-control analyses in regulatory decision making.
Journal of clinical pharmacology 2013;53(2):160-6.
2013: Demiana William-Faltaos; Ying Chen; Jogarao V S Gobburu; Yaning Wang; Hao Zhu
Quantification of disease progression and dropout for Alzheimer's disease.
International journal of clinical pharmacology and therapeutics 2013;51(2):120-31.
2012: Shailly Mehrotra; Jeffry Florian; Jogarao V S Gobburu
Don't get boxed in: commentary on the visual inspection practices to assess exposure-response relationships from binary clinical variables.
Journal of clinical pharmacology 2012;52(12):1912-7.
2012: Yaning Wang; Pravin R Jadhav; Mallika Lala; Jogarao V S Gobburu
Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies.
Journal of clinical pharmacology 2012;52(10):1601-6.
2012: Hobart L Rogers; Issam Zineh; Atul Bhattaram; Jogarao V S Gobburu; Thomas Laughren; Mitchell Mathis; Michael Pacanowski
CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations.
The Journal of clinical psychiatry 2012;73(9):1187-90.
2012: Yaning Wang; Badrul A Chowdhury; Joo Yeon Lee; Theresa Michele; Jogarao V S Gobburu
Limitations of model based dose selection for indacaterol in patients with chronic obstructive pulmonary disease.
International journal of clinical pharmacology and therapeutics 2012;50(9):622-30.
2012: Yuyan Jin; Robert Bies; Marc R Gastonguay; Jogarao V S Gobburu; Norman Stockbridge; Rajanikanth Madabushi
Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice: a clinical trial simulation case study.
Journal of pharmacokinetics and pharmacodynamics 2012;39(3):283-94.
2012: Todd S Perlstein; Joo-Yeon Lee; Lawrence J Lesko; David Schoenfeld; Jogarao V S Gobburu; Samuel Z Goldhaber; T Vance Morgan; Mason W Freeman; Kerrie Nelson; Raju Kucherlapati; Victoria Joshi; Mark A Creager
The Creating an Optimal Warfarin Nomogram (CROWN) Study.
Thrombosis and haemostasis 2012;107(1):59-68.
2011: Joo Yeon Lee; Jogarao V S Gobburu
Bayesian quantitative disease-drug-trial models for Parkinson's disease to guide early drug development.
The AAPS journal 2011;13(4):508-18.
2011: Kevin Krudys; Atul Bhattaram; Ying Chen; Jeffry Florian; Jogarao V S Gobburu; Pravin R Jadhav; Fang Li; Lauren Neal; Christoffer Tornoe; Yaning Wang; Peter I D Lee
Knowledge management for efficient quantitative analyses during regulatory reviews.
Expert review of clinical pharmacology 2011;4(6):697-703.
2011: Edward D Bashaw; Gilbert Burckart; Rosane Charlab; Timothy R Coté; Christine E Garnett; Jogarao V S Gobburu; Shiew-Mei Huang; Christine D Le; Angela Y Men; Anne R Pariser; Lei Zhang; Lawrence J Lesko
Clinical pharmacology as a cornerstone of orphan drug development.
Nature reviews. Drug discovery 2011;10(11):795-6.
2011: Joo Yeon Lee; Lawrence J Lesko; Fang Li; Jiang Liu; Rajanikanth Madabushi; Anshu Marathe; Nitin Mehrotra; Christoffer Tornoe; Yaning Wang; Venkatesh Atul Bhattaram; Satjit Brar; Justin C Earp; Christine E Garnett; Jogarao V S Gobburu; Pravin R Jadhav; Kevin Krudys; Hao Zhu
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Clinical pharmacokinetics 2011;50(10):627-35.
2011: Thomas Laughren; Jee Eun Lee; Robert L Levin; Cheri Y Lindberg; Mitchell Mathis; Barry N Rosloff; Robert J Temple; Ellis F Unger; Sue-Jane Wang; Yaning Wang; Peiling Yang; Bei Yu; Huixia Zhang; Li Zhang; Atul Bhattaram; Phillip V Dinh; Linda Fossom; Jogarao V S Gobburu; H M James Hung; Violetta Klimek; Issam Zineh
Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.
The Journal of clinical psychiatry 2011;72(9):1166-73.
2011: D Menon-Andersen; Norman Stockbridge; R Temple; Ramana S Uppoor; B Yu; W Hao; Thomas Laughren; Lawrence J Lesko; Rajanikanth Madabushi; M Mehta; V Bhattaram; Jogarao V S Gobburu
Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label.
Clinical pharmacology and therapeutics 2011;90(3):471-4.
2011: Christoffer W Tornøe; Yaning Wang; Jeffry Florian; Christine E Garnett; Michael Li; Jogarao V S Gobburu
Creation of a knowledge management system for QT analyses.
Journal of clinical pharmacology 2011;51(7):1035-42.
2011: Rajanikanth Madabushi; Donna S Cox; Mohammad Hossain; Duane A Boyle; Bela R Patel; Guy Young; Young-Moon Choi; Jogarao V S Gobburu
Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics.
Journal of clinical pharmacology 2011;51(1):19-28.
2010: Hao Zhu; Yaning Wang; Jogarao V S Gobburu; Christine E Garnett
Considerations for clinical trial design and data analyses of thorough QT studies using drug-drug interaction.
Journal of clinical pharmacology 2010;50(10):1106-11.
2010: Jogarao V S Gobburu
Pharmacometrics 2020.
Journal of clinical pharmacology 2010;50(9 Suppl):151S-157S.
2010: Klaus Romero; Brian Corrigan; Christoffer W Tornoe; Jogarao V S Gobburu; Meindert Danhof; William R Gillespie; Marc R Gastonguay; Bernd Meibohm; Hartmut Derendorf
Pharmacometrics as a discipline is entering the "industrialization" phase: standards, automation, knowledge sharing, and training are critical for future success.
Journal of clinical pharmacology 2010;50(9 Suppl):9S-19S.
2010: M J Goldberger; N Singh; S Allerheiligen; S Allerheiligan; Jogarao V S Gobburu; R Lalonde; B Smith; S Ryder; A Yozviak
ASCPT Task Force for advancing pharmacometrics and integration into drug development.
Clinical pharmacology and therapeutics 2010;88(2):158-61.
2010: S H Jang; P M Colangelo; Jogarao V S Gobburu
Exposure-response of posaconazole used for prophylaxis against invasive fungal infections: evaluating the need to adjust doses based on drug concentrations in plasma.
Clinical pharmacology and therapeutics 2010;88(1):115-9.
2009: Venkatesh Atul Bhattaram; Ohidul Siddiqui; Leonard P Kapcala; Jogarao V S Gobburu
Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease.
The AAPS journal 2009;11(3):456-64.
2009: Yaning Wang; C Sung; C Dartois; Roshni P Ramchandani; Brian P Booth; E Rock; Jogarao V S Gobburu
Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development.
Clinical pharmacology and therapeutics 2009;86(2):167-74.
2009: Pravin R Jadhav; Jialu Zhang; Jogarao V S Gobburu
Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.
Pharmaceutical statistics 2009;8(3):216-24.
2009: Jogarao V S Gobburu
Biomarkers in clinical drug development.
Clinical pharmacology and therapeutics 2009;86(1):26-7.
2009: Jogarao V S Gobburu; Lawrence J Lesko
Quantitative disease, drug, and trial models.
Annual review of pharmacology and toxicology 2009;49():291-301.
2008: Jogarao V S Gobburu
Disease models.
Clinical advances in hematology & oncology : H&O 2008;6(4):241-2.
2008: Daniel K Benjamin; P Brian Smith; Pravin Jadhav; Jogarao V S Gobburu; M Dianne Murphy; Vic Hasselblad; Carissa Marrie Baker-Smith; Robert M Califf; Jennifer S Li
Pediatric antihypertensive trial failures: analysis of end points and dose range.
Hypertension 2008;51(4):834-40.
2008: Yaning Wang; A Venkatesh Bhattaram; Pravin R Jadhav; Lawrence J Lesko; Rajanikanth Madabushi; J Robert Powell; Wei Qiu; He Sun; Dong S Yim; Jenny J Zheng; Jogarao V S Gobburu
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
Journal of clinical pharmacology 2008;48(2):146-56.
2008: Michael Brave; Vicki Goodman; Edvardas Kaminskas; Ann Farrell; William Timmer; Sarah Pope; Ravi Harapanhalli; Haleh Saber; David Morse; Julie Bullock; Angela Men; Carol Noory; Roshni P Ramchandani; Leslie Kenna; Brian Booth; Jogarao V S Gobburu; Xiaoping Jiang; R Sridhara; Robert Justice; Richard Pazdur
Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate.
Clinical cancer research : an official journal of the American Association for Cancer Research 2008;14(2):352-9.
2008: Christine E Garnett; Nhi Beasley; Venkatesh Atul Bhattaram; Pravin R Jadhav; Rajanikanth Madabushi; Norman Stockbridge; Christoffer W Tornøe; Yaning Wang; Hao Zhu; Jogarao V S Gobburu
Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.
Journal of clinical pharmacology 2008;48(1):13-8.
2007: Christoffer W Tornøe; Jeffrey J Tworzyanski; Menfo A Imoisili; John J Alexander; Joan Korth-Bradley; Jogarao V S Gobburu
Optimising piperacillin/tazobactam dosing in paediatrics.
International journal of antimicrobial agents 2007;30(4):320-4.
2007: J Robert Powell; Jogarao V S Gobburu
Pharmacometrics at FDA: evolution and impact on decisions.
Clinical pharmacology and therapeutics 2007;82(1):97-102.
2007: Vicki L Goodman; Edwin P Rock; Ramzi Dagher; Roshni P Ramchandani; Sophia Abraham; Jogarao V S Gobburu; Brian P Booth; S Leigh Verbois; David E Morse; Cheng Yi Liang; Nallaperumal Chidambaram; Janet X Jiang; Shenghui Tang; Kooros Mahjoob; Robert Justice; Richard Pazdur
Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2007;13(5):1367-73.
2007: Venkatesh Atul Bhattaram; C Bonapace; D M Chilukuri; John Z Duan; C Garnett; Jogarao V S Gobburu; S H Jang; L Kenna; Lawrence J Lesko; Rajanikanth Madabushi; Y Men; J Robert Powell; W Qiu; Roshni P Ramchandani; C W Tornoe; Yaning Wang; J J Zheng
Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.
Clinical pharmacology and therapeutics 2007;81(2):213-21.
2007: Brian P Booth; Atiqur Rahman; Ramzi Dagher; Donna Griebel; Shari Lennon; David Fuller; Chandra Sahajwalla; Mehul Mehta; Jogarao V S Gobburu
Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients.
Journal of clinical pharmacology 2007;47(1):101-11.
2007: Roshni P Ramchandani; Yaning Wang; Brian P Booth; Amna Ibrahim; John R Johnson; Atiqur Rahman; Mehul Mehta; Federico Innocenti; Mark J Ratain; Jogarao V S Gobburu
The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity.
Journal of clinical pharmacology 2007;47(1):78-86.
2006: Michael Brave; Ramzi Dagher; Ann Farrell; Sophia Abraham; Roshni P Ramchandani; Jogarao V S Gobburu; Brian Booth; Xiaoping Jiang; R Sridhara; Robert Justice; Richard Pazdur
Topotecan in combination with cisplatin for the treatment of stage IVB, recurrent, or persistent cervical cancer.
Oncology (Williston Park, N.Y.) 2006;20(11):1401-4, 1410; discussion 1410-11, 1415-6.
2006: Pravin R Jadhav; Henrik Agersø; Christoffer W Tornøe; Jogarao V S Gobburu
Semi-mechanistic pharmacodynamic modeling for degarelix, a novel gonadotropin releasing hormone (GnRH) blocker.
Journal of pharmacokinetics and pharmacodynamics 2006;33(5):609-34.
2006: Martin H Cohen; John R Johnson; Tristan Massie; R Sridhara; W David McGuinn; Sophia Abraham; Brian P Booth; M Anwar Goheer; David Morse; Xiao H Chen; Nallaperumal Chidambaram; Leslie Kenna; Jogarao V S Gobburu; Robert Justice; Richard Pazdur
Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2006;12(18):5329-35.
2005: John R Johnson; Martin Cohen; R Sridhara; Yeh-Fong Chen; Gene M Williams; John Duan; Jogarao V S Gobburu; Brian Booth; Kimberly Benson; John Leighton; Li Shan Hsieh; Nallaperumal Chidambaram; Paul Zimmerman; Richard Pazdur
Approval summary for erlotinib for treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Clinical cancer research : an official journal of the American Association for Cancer Research 2005;11(18):6414-21.
2005: Mathangi Gopalakrishnan; Sandra Suarez; Anthony J Hickey; Jogarao V S Gobburu
Population pharmacokinetic-pharmacodynamic modeling of subcutaneous and pulmonary insulin in rats.
Journal of pharmacokinetics and pharmacodynamics 2005;32(3-4):485-500.
2005: Maitreyee Hazarika; Robert M White; Brian P Booth; Yong-Cheng Wang; Doo Y Lee Ham; Cheng Yi Liang; Atiqur Rahman; Jogarao V S Gobburu; Ning Li; R Sridhara; David E Morse; Richard T Lostritto; Patricia Garvey; John R Johnson; Richard Pazdur
Pemetrexed in malignant pleural mesothelioma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2005;11(3):982-92.
2005: Pravin R Jadhav; Jogarao V S Gobburu
A new equivalence based metric for predictive check to qualify mixed-effects models.
The AAPS journal 2005;7(3):E523-31.
2005: Venkatesh Atul Bhattaram; Brian P Booth; Roshni P Ramchandani; B Nhi Beasley; Yaning Wang; Veneeta Tandon; John Z Duan; Raman K Baweja; Patrick J Marroum; Ramana S Uppoor; Nam Atiqur Rahman; Chandra Sahajwalla; J Robert Powell; Mehul U Mehta; Jogarao V S Gobburu
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
The AAPS journal 2005;7(3):E503-12.
2004: Peter F Bross; Robert Kane; Ann T Farrell; Sophia Abraham; Kimberly Benson; Margaret E Brower; Sean Bradley; Jogarao V S Gobburu; Anwar Goheer; Shwu-Luan Lee; John Leighton; Cheng Yi Liang; Richard T Lostritto; W David McGuinn; David E Morse; Atiqur Rahman; Lilliam A Rosario; S Leigh Verbois; Grant Williams; Yong-Cheng Wang; Richard Pazdur
Approval summary for bortezomib for injection in the treatment of multiple myeloma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2004;10(12 Pt 1):3954-64.
2003: Brian P Booth; Jogarao V S Gobburu
Considerations in analyzing single-trough concentrations using mixed-effects modeling.
Journal of clinical pharmacology 2003;43(12):1307-15.
2003: Amna Ibrahim; Nancy Scher; Grant Williams; R Sridhara; Ning Li; Gang Chen; John Leighton; Brian Booth; Jogarao V S Gobburu; Atiqur Rahman; Yung Hsieh; Rebecca Wood; Debra Vause; Richard Pazdur
Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases.
Clinical cancer research : an official journal of the American Association for Cancer Research 2003;9(7):2394-9.
2003: John R Johnson; Peter Bross; Martin Cohen; Mark Rothmann; Gang Chen; Anne Zajicek; Jogarao V S Gobburu; Atiqur Rahman; Ann Staten; Richard Pazdur
Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase.
Clinical cancer research : an official journal of the American Association for Cancer Research 2003;9(6):1972-9.
2002: Ramzi Dagher; Martin Cohen; Gene Williams; Mark Rothmann; Jogarao V S Gobburu; Gabriel Robbie; Atiqur Rahman; Gang Chen; Ann Staten; Donna Griebel; Richard Pazdur
Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors.
Clinical cancer research : an official journal of the American Association for Cancer Research 2002;8(10):3034-8.
2002: Jogarao V S Gobburu; V J Sekar
Application of modeling and simulation to integrate clinical pharmacology knowledge across a new drug application.
International journal of clinical pharmacology and therapeutics 2002;40(7):281-8.
2002: Martin H Cohen; Grant Williams; John R Johnson; John Duan; Jogarao V S Gobburu; Atiqur Rahman; Kimberly Benson; John Leighton; Sung K Kim; Rebecca Wood; Mark Rothmann; Gang Chen; Khin Maung U; Ann Staten; Richard Pazdur
Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia.
Clinical cancer research : an official journal of the American Association for Cancer Research 2002;8(5):935-42.
2002: Patrick J Marroum; Jogarao V S Gobburu
The product label: how pharmacokinetics and pharmacodynamics reach the prescriber.
Clinical pharmacokinetics 2002;41(3):161-9.
2002: Jogarao V S Gobburu; John Lawrence
Application of resampling techniques to estimate exact significance levels for covariate selection during nonlinear mixed effects model building: some inferences.
Pharmaceutical research 2002;19(1):92-8.
2001: Jogarao V S Gobburu; N H Holford
Vz, the terminal phase volume: time for its terminal phase?
Journal of biopharmaceutical statistics 2001;11(4):373-5.
2001: Jogarao V S Gobburu; VK Tammara; Lawrence J Lesko; Stanford S Jhee; John J Sramek; Neal R Cutler; R Yuan
Pharmacokinetic-pharmacodynamic modeling of rivastigmine, a cholinesterase inhibitor, in patients with Alzheimer's disease.
Journal of clinical pharmacology 2001;41(10):1082-90.
2001: Jogarao V S Gobburu; William J Jusko
Role of dosage regimen in controlling indirect pharmacodynamic responses.
Advanced drug delivery reviews 2001;46(1-3):45-57.
2001: Jogarao V S Gobburu; Patrick J Marroum
Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making.
Clinical pharmacokinetics 2001;40(12):883-92.
2000: Peter Veng-Pedersen; Jogarao V S Gobburu; Marvin C Meyer; Arthur B Straughn
Carbamazepine level-A in vivo-in vitro correlation (IVIVC): a scaled convolution based predictive approach.
Biopharmaceutics & drug disposition 2000;21(1):1-6.
1999: Jogarao V S Gobburu; Henrik Agersø; William J Jusko; L Ynddal
Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers.
Pharmaceutical research 1999;16(9):1412-6.
1999: G M Meno-Tetang; Jogarao V S Gobburu; W J Jusko
Influence of gender on prednisolone effects on whole blood T-cell deactivation and trafficking in rats.
Journal of pharmaceutical sciences 1999;88(1):46-51.
1998: Jogarao V S Gobburu; C Tenhoor; M C Rogge; D E Frazier; D Thomas; Christopher D Benjamin; D M Hess; William J Jusko
Pharmacokinetics/dynamics of 5c8, a monoclonal antibody to CD154 (CD40 ligand) suppression of an immune response in monkeys.
The Journal of pharmacology and experimental therapeutics 1998;286(2):925-30.
1996: Jogarao V S Gobburu; E P Chen
Artificial neural networks as a novel approach to integrated pharmacokinetic-pharmacodynamic analysis.
Journal of pharmaceutical sciences 1996;85(5):505-10.
1995: Jogarao V S Gobburu; W H Shelver
Quantitative structure-pharmacokinetic relationships (QSPR) of beta blockers derived using neural networks.
Journal of pharmaceutical sciences 1995;84(7):862-5.