Format
Sort by
Items per page

Send to

Choose Destination

Search results

Items: 1 to 50 of 68

1.

Clinical Pharmacology-Driven Translational Research to Optimize Bedside Therapeutics of Sotalol Therapy.

Dahmane E, Tang K, Gobburu JVS, Mattingly TJ 2nd, Reed BN, See VY, Ayres J, Ivaturi V.

Clin Transl Sci. 2019 Nov;12(6):648-656. doi: 10.1111/cts.12670. Epub 2019 Aug 12.

PMID:
31328888
2.

Population Pharmacokinetic Modeling of Gentamicin in Pediatrics.

Wang H, Sherwin C, Gobburu JVS, Ivaturi V.

J Clin Pharmacol. 2019 Dec;59(12):1584-1596. doi: 10.1002/jcph.1479. Epub 2019 Jul 8.

PMID:
31286535
3.

Could Postnatal Age-Related Uridine Diphosphate Glucuronic Acid Be a Rate-Limiting Factor in the Metabolism of Morphine During the First Week of Life?

Liu T, Lewis TR, Moore JN, Kraft WK, Gauda EB, Sartori D, Moody DE, Gobburu JVS, Ivaturi V.

CPT Pharmacometrics Syst Pharmacol. 2019 Jul;8(7):469-477. doi: 10.1002/psp4.12407. Epub 2019 May 10.

4.

Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults.

Liu T, Gobburu JVS, Po MD, McLean A, DeSousa NJ, Sallee FR, Incledon B.

J Child Adolesc Psychopharmacol. 2019 Apr;29(3):181-191. doi: 10.1089/cap.2018.0122. Epub 2019 Feb 27.

5.

Correction: Preservation of myocardial contractility during acute hypoxia with OMX-CV, a novel oxygen delivery biotherapeutic.

Boehme J, Le Moan N, Kameny RJ, Loucks A, Johengen MJ, Lesneski AL, Gong W, Goudy BD, Davis T, Tanaka K, Davis A, He Y, Long-Boyle J, Ivaturi V, Gobburu JVS, Winger JA, Cary SP, Datar SA, Fineman JR, Krtolica A, Maltepe E.

PLoS Biol. 2019 Jan 24;17(1):e3000119. doi: 10.1371/journal.pbio.3000119. eCollection 2019 Jan.

6.

Noninvasive 11C-rifampin positron emission tomography reveals drug biodistribution in tuberculous meningitis.

Tucker EW, Guglieri-Lopez B, Ordonez AA, Ritchie B, Klunk MH, Sharma R, Chang YS, Sanchez-Bautista J, Frey S, Lodge MA, Rowe SP, Holt DP, Gobburu JVS, Peloquin CA, Mathews WB, Dannals RF, Pardo CA, Kannan S, Ivaturi VD, Jain SK.

Sci Transl Med. 2018 Dec 5;10(470). pii: eaau0965. doi: 10.1126/scitranslmed.aau0965.

PMID:
30518610
7.

Peptide-based PET quantifies target engagement of PD-L1 therapeutics.

Kumar D, Lisok A, Dahmane E, McCoy M, Shelake S, Chatterjee S, Allaj V, Sysa-Shah P, Wharram B, Lesniak WG, Tully E, Gabrielson E, Jaffee EM, Poirier JT, Rudin CM, Gobburu JV, Pomper MG, Nimmagadda S.

J Clin Invest. 2019 Feb 1;129(2):616-630. doi: 10.1172/JCI122216. Epub 2019 Jan 7.

8.

Preservation of myocardial contractility during acute hypoxia with OMX-CV, a novel oxygen delivery biotherapeutic.

Boehme J, Le Moan N, Kameny RJ, Loucks A, Johengen MJ, Lesneski AL, Gong W, Goudy BD, Davis T, Tanaka K, Davis A, He Y, Long-Boyle J, Ivaturi V, Gobburu JVS, Winger JA, Cary SP, Datar SA, Fineman JR, Krtolica A, Maltepe E.

PLoS Biol. 2018 Oct 18;16(10):e2005924. doi: 10.1371/journal.pbio.2005924. eCollection 2018 Oct. Erratum in: PLoS Biol. 2019 Jan 24;17(1):e3000119.

9.

Sorafenib Dose Recommendation in Acute Myeloid Leukemia Based on Exposure-FLT3 Relationship.

Liu T, Ivaturi V, Sabato P, Gobburu JVS, Greer JM, Wright JJ, Smith BD, Pratz KW, Rudek MA; ETCTN-6745 study team.

Clin Transl Sci. 2018 Jul;11(4):435-443. doi: 10.1111/cts.12555. Epub 2018 Apr 27. Erratum in: Clin Transl Sci. 2018 Nov;11(6):624.

10.
11.

Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance).

Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV.

AAPS J. 2017 Sep;19(5):1411-1423. doi: 10.1208/s12248-017-0101-9. Epub 2017 Jun 15.

12.

Bayesian Forecasting Tool to Predict the Need for Antidote in Acute Acetaminophen Overdose.

Desrochers J, Wojciechowski J, Klein-Schwartz W, Gobburu JVS, Gopalakrishnan M.

Pharmacotherapy. 2017 Aug;37(8):916-926. doi: 10.1002/phar.1972. Epub 2017 Jul 26.

PMID:
28609563
13.

Exposure-response analysis after subcutaneous administration of RBP-7000, a once-a-month long-acting Atrigel formulation of risperidone.

Ivaturi V, Gopalakrishnan M, Gobburu JVS, Zhang W, Liu Y, Heidbreder C, Laffont CM.

Br J Clin Pharmacol. 2017 Jul;83(7):1476-1498. doi: 10.1111/bcp.13246. Epub 2017 Mar 31.

14.

Allometry Is a Reasonable Choice in Pediatric Drug Development.

Liu T, Ghafoori P, Gobburu JV.

J Clin Pharmacol. 2017 Apr;57(4):469-475. doi: 10.1002/jcph.831. Epub 2016 Nov 22.

PMID:
27649629
15.

Population Pharmacokinetics of an Intranasally Administered Combination of Oxymetazoline and Tetracaine in Healthy Volunteers.

Cacek AT, Gobburu JV, Gopalakrishnan M.

J Clin Pharmacol. 2017 Feb;57(2):247-254. doi: 10.1002/jcph.799. Epub 2016 Aug 23.

PMID:
27436060
16.

Challenges in developing drugs for pediatric CNS disorders: A focus on psychopharmacology.

Grabb MC, Gobburu JVS.

Prog Neurobiol. 2017 May;152:38-57. doi: 10.1016/j.pneurobio.2016.05.003. Epub 2016 May 20. Review.

PMID:
27216638
17.

Should pharmacometrics be training the next R&D president?

Gobburu JV.

Clin Pharmacol Ther. 2014 Jun;95(6):579-80. doi: 10.1038/clpt.2014.68.

PMID:
24842637
18.

Genetics-based pediatric warfarin dosage regimen derived using pharmacometric bridging.

Lala M, Burckart GJ, Takao CM, Pravica V, Momper JD, Gobburu JV.

J Pediatr Pharmacol Ther. 2013 Jul;18(3):209-19. doi: 10.5863/1551-6776-18.3.209.

19.

The combination of exposure-response and case-control analyses in regulatory decision making.

Yang J, Zhao H, Garnett C, Rahman A, Gobburu JV, Pierce W, Schechter G, Summers J, Keegan P, Booth B, Wang Y.

J Clin Pharmacol. 2013 Feb;53(2):160-6. doi: 10.1177/0091270012445206. Epub 2013 Jan 24.

PMID:
23436261
20.

An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia.

Younis IR, Laughren TP, Wang Y, Mathis M, Gobburu JV.

J Clin Psychopharmacol. 2013 Apr;33(2):152-6. doi: 10.1097/JCP.0b013e31828393a8.

PMID:
23422374
21.

Limitations of model based dose selection for indacaterol in patients with chronic obstructive pulmonary disease.

Wang Y, Lee JY, Michele T, Chowdhury BA, Gobburu JV.

Int J Clin Pharmacol Ther. 2012 Sep;50(9):622-30. doi: 10.5414/CP201758.

PMID:
22578206
22.

Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies.

Wang Y, Jadhav PR, Lala M, Gobburu JV.

J Clin Pharmacol. 2012 Oct;52(10):1601-6. Epub 2011 Dec 12. No abstract available.

PMID:
22162537
23.

Clinical pharmacology as a cornerstone of orphan drug development.

Bashaw ED, Huang SM, Coté TR, Pariser AR, Garnett CE, Burckart G, Zhang L, Men AY, Le CD, Charlab R, Gobburu JV, Lesko LJ.

Nat Rev Drug Discov. 2011 Oct 31;10(11):795-6. doi: 10.1038/nrd3595.

PMID:
22037026
24.

Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, Jadhav PR, Krudys K, Lesko LJ, Li F, Liu J, Madabushi R, Marathe A, Mehrotra N, Tornoe C, Wang Y, Zhu H.

Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000.

PMID:
21895036
25.

Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label.

Menon-Andersen D, Yu B, Madabushi R, Bhattaram V, Hao W, Uppoor RS, Mehta M, Lesko L, Temple R, Stockbridge N, Laughren T, Gobburu JV.

Clin Pharmacol Ther. 2011 Sep;90(3):471-4. doi: 10.1038/clpt.2011.149. Epub 2011 Jul 27. No abstract available.

PMID:
21796114
26.

Bayesian quantitative disease-drug-trial models for Parkinson's disease to guide early drug development.

Lee JY, Gobburu JV.

AAPS J. 2011 Dec;13(4):508-18. doi: 10.1208/s12248-011-9293-6. Epub 2011 Jul 27.

27.

Creation of a knowledge management system for QT analyses.

Tornøe CW, Garnett CE, Wang Y, Florian J, Li M, Gobburu JV.

J Clin Pharmacol. 2011 Jul;51(7):1035-42. doi: 10.1177/0091270010378408. Epub 2010 Oct 26.

PMID:
20978278
28.

Pharmacometrics 2020.

Gobburu JV.

J Clin Pharmacol. 2010 Sep;50(9 Suppl):151S-157S. doi: 10.1177/0091270010376977.

PMID:
20881229
29.

Pharmacometrics as a discipline is entering the "industrialization" phase: standards, automation, knowledge sharing, and training are critical for future success.

Romero K, Corrigan B, Tornoe CW, Gobburu JV, Danhof M, Gillespie WR, Gastonguay MR, Meibohm B, Derendorf H.

J Clin Pharmacol. 2010 Sep;50(9 Suppl):9S-19S. doi: 10.1177/0091270010377788. No abstract available.

PMID:
20881213
30.

ASCPT Task Force for advancing pharmacometrics and integration into drug development.

Goldberger MJ, Singh N, Allerheiligen S, Gobburu JV, Lalonde R, Smith B, Ryder S, Yozviak A.

Clin Pharmacol Ther. 2010 Aug;88(2):158-61. doi: 10.1038/clpt.2010.141. Review. Erratum in: Clin Pharmacol Ther. 2010 Dec;88(6):883.. Allerheiligan, S [corrected to Allerheiligen, S].

PMID:
20648032
31.

Exposure-response of posaconazole used for prophylaxis against invasive fungal infections: evaluating the need to adjust doses based on drug concentrations in plasma.

Jang SH, Colangelo PM, Gobburu JV.

Clin Pharmacol Ther. 2010 Jul;88(1):115-9. doi: 10.1038/clpt.2010.64. Epub 2010 May 26.

PMID:
20505665
32.

Considerations for clinical trial design and data analyses of thorough QT studies using drug-drug interaction.

Zhu H, Wang Y, Gobburu JV, Garnett CE.

J Clin Pharmacol. 2010 Oct;50(10):1106-11. doi: 10.1177/0091270009358710. Epub 2010 May 10. No abstract available.

PMID:
20457587
33.

Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics.

Madabushi R, Cox DS, Hossain M, Boyle DA, Patel BR, Young G, Choi YM, Gobburu JV.

J Clin Pharmacol. 2011 Jan;51(1):19-28. doi: 10.1177/0091270010365550. Epub 2010 Apr 26.

PMID:
20421511
34.

Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.

Jadhav PR, Zhang J, Gobburu JV.

Pharm Stat. 2009 Jul-Sep;8(3):216-24. doi: 10.1002/pst.394.

PMID:
19610013
35.

Biomarkers in clinical drug development.

Gobburu JV.

Clin Pharmacol Ther. 2009 Jul;86(1):26-7. doi: 10.1038/clpt.2009.57. Review.

PMID:
19536121
36.

Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease.

Bhattaram VA, Siddiqui O, Kapcala LP, Gobburu JV.

AAPS J. 2009 Sep;11(3):456-64. doi: 10.1208/s12248-009-9123-2. Epub 2009 Jun 12.

37.

Quantitative disease, drug, and trial models.

Gobburu JV, Lesko LJ.

Annu Rev Pharmacol Toxicol. 2009;49:291-301. doi: 10.1146/annurev.pharmtox.011008.145613. Review.

PMID:
18851702
38.

Pediatric antihypertensive trial failures: analysis of end points and dose range.

Benjamin DK Jr, Smith PB, Jadhav P, Gobburu JV, Murphy MD, Hasselblad V, Baker-Smith C, Califf RM, Li JS.

Hypertension. 2008 Apr;51(4):834-40. doi: 10.1161/HYPERTENSIONAHA.107.108886. Epub 2008 Mar 10.

39.

Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.

Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV.

J Clin Pharmacol. 2008 Feb;48(2):146-56. doi: 10.1177/0091270007311111.

PMID:
18199891
40.

Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.

Garnett CE, Beasley N, Bhattaram VA, Jadhav PR, Madabushi R, Stockbridge N, Tornøe CW, Wang Y, Zhu H, Gobburu JV.

J Clin Pharmacol. 2008 Jan;48(1):13-8. Review.

PMID:
18094216
41.

Optimising piperacillin/tazobactam dosing in paediatrics.

Tornøe CW, Tworzyanski JJ, Imoisili MA, Alexander JJ, Korth-Bradley JM, Gobburu JV.

Int J Antimicrob Agents. 2007 Oct;30(4):320-4. Epub 2007 Jul 13.

PMID:
17631983
42.

Pharmacometrics at FDA: evolution and impact on decisions.

Powell JR, Gobburu JV.

Clin Pharmacol Ther. 2007 Jul;82(1):97-102. Epub 2007 May 30. Review.

PMID:
17538553
43.

Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma.

Goodman VL, Rock EP, Dagher R, Ramchandani RP, Abraham S, Gobburu JV, Booth BP, Verbois SL, Morse DE, Liang CY, Chidambaram N, Jiang JX, Tang S, Mahjoob K, Justice R, Pazdur R.

Clin Cancer Res. 2007 Mar 1;13(5):1367-73. Review.

44.

Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.

Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y, Zheng JJ.

Clin Pharmacol Ther. 2007 Feb;81(2):213-21.

PMID:
17259946
45.

Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients.

Booth BP, Rahman A, Dagher R, Griebel D, Lennon S, Fuller D, Sahajwalla C, Mehta M, Gobburu JV.

J Clin Pharmacol. 2007 Jan;47(1):101-11.

PMID:
17192508
46.

The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity.

Ramchandani RP, Wang Y, Booth BP, Ibrahim A, Johnson JR, Rahman A, Mehta M, Innocenti F, Ratain MJ, Gobburu JV.

J Clin Pharmacol. 2007 Jan;47(1):78-86.

PMID:
17192505
47.

Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma.

Cohen MH, Johnson JR, Massie T, Sridhara R, McGuinn WD Jr, Abraham S, Booth BP, Goheer MA, Morse D, Chen XH, Chidambaram N, Kenna L, Gobburu JV, Justice R, Pazdur R.

Clin Cancer Res. 2006 Sep 15;12(18):5329-35.

48.

Semi-mechanistic pharmacodynamic modeling for degarelix, a novel gonadotropin releasing hormone (GnRH) blocker.

Jadhav PR, Agersø H, Tornøe CW, Gobburu JV.

J Pharmacokinet Pharmacodyn. 2006 Oct;33(5):609-34. Epub 2006 Aug 8.

PMID:
16967346
49.

A new equivalence based metric for predictive check to qualify mixed-effects models.

Jadhav PR, Gobburu JV.

AAPS J. 2005 Oct 7;7(3):E523-31. Review.

50.

Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV.

AAPS J. 2005 Oct 7;7(3):E503-12. Review.

Supplemental Content

Loading ...
Support Center