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Items: 1 to 50 of 102

1.

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.

2.

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
3.

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.

4.

Population pharmacokinetics and exposure-response assessment of veliparib co-administered with temozolomide in patients with myeloid leukemias.

Singh R, Mehrotra S, Gopalakrishnan M, Gojo I, Karp JE, Greer JM, Chen A, Piekarz R, Kiesel BF, Gobburu J, Rudek MA, Beumer JH; ETCTN-6745 study team.

Cancer Chemother Pharmacol. 2018 Nov 20. doi: 10.1007/s00280-018-3731-4. [Epub ahead of print]

PMID:
30456480
5.

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.

6.

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.

7.

Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus®) and Lantus® in healthy subjects: a double-blind, randomized clamp study.

Bhatia A, Tawade S, Mastim M, Kitabi EN, Gopalakrishnan M, Shah M, Yeshamaina S, Gobburu J, Sahib M, Thakur D, Prasanna Kumar KM.

Acta Diabetol. 2018 May;55(5):461-468. doi: 10.1007/s00592-018-1113-3. Epub 2018 Feb 16.

PMID:
29453671
8.
9.

Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder.

Childress A, Mehrotra S, Gobburu J, McLean A, DeSousa NJ, Incledon B.

J Child Adolesc Psychopharmacol. 2018 Feb;28(1):10-18. doi: 10.1089/cap.2017.0044. Epub 2017 Oct 17.

10.

Exposure-Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies.

Mehrotra S, Gopalakrishnan M, Gobburu J, Ji J, Greer JM, Piekarz R, Karp JE, Pratz KW, Rudek MA.

Clin Cancer Res. 2017 Nov 1;23(21):6421-6429. doi: 10.1158/1078-0432.CCR-17-0143. Epub 2017 Jul 27.

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.

Parent-Metabolite Pharmacokinetic Modeling and Pharmacodynamics of Veliparib (ABT-888), a PARP Inhibitor, in Patients With BRCA 1/2-Mutated Cancer or PARP-Sensitive Tumor Types.

Niu J, Scheuerell C, Mehrotra S, Karan S, Puhalla S, Kiesel BF, Ji J, Chu E, Gopalakrishnan M, Ivaturi V, Gobburu J, Beumer JH.

J Clin Pharmacol. 2017 Aug;57(8):977-987. doi: 10.1002/jcph.892. Epub 2017 Apr 7.

14.

Exposure-Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients.

LaCerte C, Ivaturi V, Gobburu J, Greer JM, Doyle LA, Wright JJ, Karp JE, Rudek MA.

Clin Cancer Res. 2017 Jul 15;23(14):3592-3600. doi: 10.1158/1078-0432.CCR-16-2629. Epub 2017 Feb 7.

15.

Population pharmacokinetics and site of action exposures of veliparib with topotecan plus carboplatin in patients with haematological malignancies.

Mehrotra S, Gopalakrishnan M, Gobburu J, Greer JM, Piekarz R, Karp JE, Pratz K, Rudek MA.

Br J Clin Pharmacol. 2017 Aug;83(8):1688-1700. doi: 10.1111/bcp.13253. Epub 2017 Mar 19.

16.

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.

17.

Erratum to: Phase I and pharmacokinetic evaluation of the anti-telomerase agent KML-001 with cisplatin in advanced solid tumors.

Edelman MJ, Lapidus R, Feliciano J, Styblo M, Beumer JH, Liu T, Gobburu J.

Cancer Chemother Pharmacol. 2016 Nov;78(5):969. No abstract available.

PMID:
27677624
18.

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
19.

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
20.

Drugs Against Rare Diseases: Are The Regulatory Standards Higher?

Gobburu J, Pastoor D.

Clin Pharmacol Ther. 2016 Oct;100(4):322-3. doi: 10.1002/cpt.415. Epub 2016 Aug 18.

21.

Communicating to Influence Drug Development and Regulatory Decisions: A Tutorial.

Mehrotra S, Gobburu J.

CPT Pharmacometrics Syst Pharmacol. 2016 Apr;5(4):163-72. doi: 10.1002/psp4.12073. Epub 2016 Apr 14.

22.

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
23.

Characterizing Class-Specific Exposure-Viral Load Suppression Response of HIV Antiretrovirals Using A Model-Based Meta-Analysis.

Xu Y, Li YF, Zhang D, Dockendorf M, Tetteh E, Rizk ML, Grobler JA, Lai MT, Gobburu J, Ankrom W.

Clin Transl Sci. 2016 Aug;9(4):192-200. doi: 10.1111/cts.12395. Epub 2016 May 12.

24.

Levonorgestrel release rates over 5 years with the Liletta® 52-mg intrauterine system.

Creinin MD, Jansen R, Starr RM, Gobburu J, Gopalakrishnan M, Olariu A.

Contraception. 2016 Oct;94(4):353-6. doi: 10.1016/j.contraception.2016.04.010. Epub 2016 Apr 25.

25.

Mechanistic Population Pharmacokinetics of Morphine in Neonates With Abstinence Syndrome After Oral Administration of Diluted Tincture of Opium.

Liu T, Lewis T, Gauda E, Gobburu J, Ivaturi V.

J Clin Pharmacol. 2016 Aug;56(8):1009-18. doi: 10.1002/jcph.696. Epub 2016 Feb 22.

26.

Pharmacometrics-guided drug development of antihyperhidrosis agents.

Mehrotra S, Schmith VD, Dumitrescu TP, Gobburu J.

J Clin Pharmacol. 2015 Nov;55(11):1256-67. doi: 10.1002/jcph.536. Epub 2015 Jun 18.

PMID:
25939678
27.

Optimizing oncology therapeutics through quantitative translational and clinical pharmacology: challenges and opportunities.

Venkatakrishnan K, Friberg LE, Ouellet D, Mettetal JT, Stein A, Trocóniz IF, Bruno R, Mehrotra N, Gobburu J, Mould DR.

Clin Pharmacol Ther. 2015 Jan;97(1):37-54. doi: 10.1002/cpt.7. Epub 2014 Dec 9. Review.

PMID:
25670382
28.

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study.

Jin Y, Bies R, Gastonguay MR, Wang Y, Stockbridge N, Gobburu J, Madabushi R.

J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):693-704. doi: 10.1007/s10928-014-9394-9. Epub 2014 Oct 18.

PMID:
25326066
29.

Drug Development and Potential Regulatory Paths for Insulin Biosimilars.

Minocha M, Gobburu J.

J Diabetes Sci Technol. 2014 Jan;8(1):14-19. Epub 2014 Jan 1.

30.

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
31.

Implications of choosing a correlation structure on model selection and parameter estimation.

Jain L, Jadhav P, Gobburu J.

Int J Clin Pharmacol Ther. 2014 Jul;52(7):598-611. doi: 10.5414/CP202058.

PMID:
24725444
32.

Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B.

Diao L, Li S, Ludden T, Gobburu J, Nestorov I, Jiang H.

Clin Pharmacokinet. 2014 May;53(5):467-77. doi: 10.1007/s40262-013-0129-7.

33.

Clinical pharmacology review of escitalopram for the treatment of depression.

Pastoor D, Gobburu J.

Expert Opin Drug Metab Toxicol. 2014 Jan;10(1):121-8. doi: 10.1517/17425255.2014.863873. Epub 2013 Nov 30. Review.

PMID:
24289655
34.

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.

35.

The future of the pharmaceutical sciences and graduate education: recommendations from the AACP Graduate Education Special Interest Group.

Wu-Pong S, Gobburu J, O'Barr S, Shah K, Huber J, Weiner D; American Association of Colleges of Pharmacy Graduate Education Special Interest Group.

Am J Pharm Educ. 2013 May 13;77(4):S2. doi: 10.5688/ajpe774S2. Review.

36.

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
37.

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
38.

Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval.

Liu J, Jadhav P, Wang Y, Gobburu J.

AAPS J. 2013 Apr;15(2):407-14. doi: 10.1208/s12248-012-9438-2. Epub 2013 Jan 10.

39.

Quantification of disease progression and dropout for Alzheimer's disease.

William-Faltaos D, Chen Y, Wang Y, Gobburu J, Zhu H.

Int J Clin Pharmacol Ther. 2013 Feb;51(2):120-31. doi: 10.5414/CP201787.

PMID:
23211395
40.

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.

Rogers HL, Bhattaram A, Zineh I, Gobburu J, Mathis M, Laughren TP, Pacanowski M.

J Clin Psychiatry. 2012 Sep;73(9):1187-90. doi: 10.4088/JCP.11m07572.

PMID:
23059146
41.

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
42.

Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice: a clinical trial simulation case study.

Jin Y, Bies R, Gastonguay MR, Stockbridge N, Gobburu J, Madabushi R.

J Pharmacokinet Pharmacodyn. 2012 Jun;39(3):283-94. doi: 10.1007/s10928-012-9250-8. Epub 2012 May 9.

PMID:
22569889
43.

Don't get boxed in: commentary on the visual inspection practices to assess exposure-response relationships from binary clinical variables.

Mehrotra S, Florian J Jr, Gobburu J.

J Clin Pharmacol. 2012 Dec;52(12):1912-7. doi: 10.1177/0091270011429568. Epub 2011 Dec 15. No abstract available.

PMID:
22174427
44.

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
45.

The Creating an Optimal Warfarin Nomogram (CROWN) Study.

Perlstein TS, Goldhaber SZ, Nelson K, Joshi V, Morgan TV, Lesko LJ, Lee JY, Gobburu J, Schoenfeld D, Kucherlapati R, Freeman MW, Creager MA.

Thromb Haemost. 2012 Jan;107(1):59-68. doi: 10.1160/TH11-08-0568. Epub 2011 Nov 24.

46.

Knowledge management for efficient quantitative analyses during regulatory reviews.

Krudys K, Li F, Florian J, Tornoe C, Chen Y, Bhattaram A, Jadhav P, Neal L, Wang Y, Gobburu J, Lee PI.

Expert Rev Clin Pharmacol. 2011 Nov;4(6):697-703. doi: 10.1586/ecp.11.56. Review.

PMID:
22111855
47.

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
48.

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.

Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I.

J Clin Psychiatry. 2011 Sep;72(9):1166-73. doi: 10.4088/JCP.11r06984. Review.

PMID:
21951984
49.

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
50.

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

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