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Items: 1 to 50 of 63

1.

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
2.

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

Kumar D, Lisok A, Dahmane E, McCoy MD, 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. 2018 Nov 20. pii: 122216. doi: 10.1172/JCI122216. [Epub ahead of print]

3.

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, 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.

4.

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.

5.
6.

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.

7.

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
8.

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.

9.

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
10.

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
11.

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
12.

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
13.

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.

14.

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
15.

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
16.

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
17.

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
18.

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
19.

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
20.

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
21.

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.

22.

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
23.

Pharmacometrics 2020.

Gobburu JV.

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

PMID:
20881229
24.

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
25.

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
26.

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
27.

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
28.

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
29.

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
30.

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
31.

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.

32.

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
33.

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.

34.

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
35.

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
36.

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
37.

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
38.

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.

39.

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
40.

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
41.

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
42.

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.

43.

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
44.

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.

45.

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.

46.

Population pharmacokinetic-pharmacodynamic modeling of subcutaneous and pulmonary insulin in rats.

Gopalakrishnan M, Suarez S, Hickey AJ, Gobburu JV.

J Pharmacokinet Pharmacodyn. 2005 Aug;32(3-4):485-500.

PMID:
16284921
47.

Pemetrexed in malignant pleural mesothelioma.

Hazarika M, White RM Jr, Booth BP, Wang YC, Ham DY, Liang CY, Rahman A, Gobburu JV, Li N, Sridhara R, Morse DE, Lostritto R, Garvey P, Johnson JR, Pazdur R.

Clin Cancer Res. 2005 Feb 1;11(3):982-92.

48.

Approval summary for bortezomib for injection in the treatment of multiple myeloma.

Bross PF, Kane R, Farrell AT, Abraham S, Benson K, Brower ME, Bradley S, Gobburu JV, Goheer A, Lee SL, Leighton J, Liang CY, Lostritto RT, McGuinn WD, Morse DE, Rahman A, Rosario LA, Verbois SL, Williams G, Wang YC, Pazdur R.

Clin Cancer Res. 2004 Jun 15;10(12 Pt 1):3954-64. No abstract available.

49.

Considerations in analyzing single-trough concentrations using mixed-effects modeling.

Booth BP, Gobburu JV.

J Clin Pharmacol. 2003 Dec;43(12):1307-15.

PMID:
14615466
50.

Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases.

Ibrahim A, Scher N, Williams G, Sridhara R, Li N, Chen G, Leighton J, Booth B, Gobburu JV, Rahman A, Hsieh Y, Wood R, Vause D, Pazdur R.

Clin Cancer Res. 2003 Jul;9(7):2394-9.

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