Vikram Sinha

Vikram Sinha

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Vikram Sinha

Vikram Sinha

Publications by authors named "Vikram Sinha"

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42Publications

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Gastrin analogue administration adds no significant glycaemic benefit to a glucagon-like peptide-1 receptor agonist acutely or after washout of both analogues.

Diabetes Obes Metab 2019 Jul 21;21(7):1606-1614. Epub 2019 Apr 21.

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.

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http://dx.doi.org/10.1111/dom.13695DOI Listing
July 2019

Industrialization of Quantitative Systems Pharmacology.

CPT Pharmacometrics Syst Pharmacol 2019 Jun 6;8(6):356-358. Epub 2019 Jun 6.

Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.

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http://dx.doi.org/10.1002/psp4.12427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617811PMC
June 2019

Concentrated insulins: History and critical reappraisal.

J Diabetes 2019 Apr 13;11(4):292-300. Epub 2018 Nov 13.

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.

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http://doi.wiley.com/10.1111/1753-0407.12861
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http://dx.doi.org/10.1111/1753-0407.12861DOI Listing
April 2019

PDUFA VI: It Is Time to Unleash the Full Potential of Model-Informed Drug Development.

CPT Pharmacometrics Syst Pharmacol 2019 Jan 29;8(1):5-8. Epub 2018 Nov 29.

Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics Pharmacodynamics and Drug Metabolism, Merck & Co., Inc., Kenilworth, New Jersey, USA.

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http://dx.doi.org/10.1002/psp4.12365DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6363279PMC
January 2019

Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients.

Clin Pharmacol Ther 2018 10 2;104(4):742-748. Epub 2018 Feb 2.

Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://doi.wiley.com/10.1002/cpt.991
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http://dx.doi.org/10.1002/cpt.991DOI Listing
October 2018

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Pediatr Clin North Am 2017 12;64(6):1185-1196

Division of Pediatric and Maternal Health, CDER US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.

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http://dx.doi.org/10.1016/j.pcl.2017.08.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5765998PMC
December 2017

Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients.

J Pediatr Gastroenterol Nutr 2016 10;63(4):412-6

*Office of Clinical Pharmacology †Division of Gastroenterology and Inborn Error Products 1, Office of Drug Evaluation III, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1097/MPG.0000000000001173DOI Listing
October 2016

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.

Drug Metab Dispos 2016 07 14;44(7):924-33. Epub 2016 Apr 14.

Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1124/dmd.116.069559DOI Listing
July 2016

The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives.

J Clin Pharmacol 2016 07;56 Suppl 7:S122-31

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1002/jcph.740DOI Listing
July 2016

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA.

Clin Pharmacokinet 2016 Apr;55(4):475-83

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

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http://dx.doi.org/10.1007/s40262-015-0330-yDOI Listing
April 2016

A proposal for scientific framework enabling specific population drug dosing recommendations.

J Clin Pharmacol 2015 Oct 30;55(10):1073-8. Epub 2015 Jul 30.

Independent Consultant, Chapel Hill, NC, USA.

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http://dx.doi.org/10.1002/jcph.579DOI Listing
October 2015

Quantitative characterization of circadian rhythm of pulmonary function in asthmatic patients treated with inhaled corticosteroids.

J Pharmacokinet Pharmacodyn 2015 Aug 23;42(4):391-9. Epub 2015 Jun 23.

Department of Pharmaceutics, College of Pharmacy, University of Florida, 1600 SW Archer Road, Gainesville, FL, USA.

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http://dx.doi.org/10.1007/s10928-015-9420-6DOI Listing
August 2015

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration.

Clin Pharmacokinet 2015 Jan;54(1):117-27

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

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http://dx.doi.org/10.1007/s40262-014-0188-4DOI Listing
January 2015

Novel PEGylated basal insulin LY2605541 has a preferential hepatic effect on glucose metabolism.

Diabetes 2014 Feb 2;63(2):494-504. Epub 2013 Oct 2.

Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine, Nashville, TN.

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http://dx.doi.org/10.2337/db13-0826DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5361402PMC
February 2014

Dose selection using a semi-mechanistic integrated glucose-insulin-glucagon model: designing phase 2 trials for a novel oral glucokinase activator.

J Pharmacokinet Pharmacodyn 2013 Feb 22;40(1):53-65. Epub 2012 Dec 22.

Global PK/PD/Pharmacometrics, Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN 46285, USA.

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http://dx.doi.org/10.1007/s10928-012-9286-9DOI Listing
February 2013

Assessment of glycemic response to an oral glucokinase activator in a proof of concept study: application of a semi-mechanistic, integrated glucose-insulin-glucagon model.

J Pharmacokinet Pharmacodyn 2013 Feb 22;40(1):67-80. Epub 2012 Dec 22.

Global PK/PD/Pharmacometrics, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.

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http://link.springer.com/content/pdf/10.1007/s10928-012-9287
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http://link.springer.com/10.1007/s10928-012-9287-8
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http://dx.doi.org/10.1007/s10928-012-9287-8DOI Listing
February 2013

Desipramine, substrate for CYP2D6 activity: population pharmacokinetic model and design elements of drug-drug interaction trials.

Br J Clin Pharmacol 2010 Oct;70(4):523-36

Lilly Research Laboratories,Department of Drug Disposition, Lilly Research Laboratories, SunninghillRoad,Windlesham, Surrey, UK.

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http://dx.doi.org/10.1111/j.1365-2125.2010.03731.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2950987PMC
October 2010

Case of carcinoid crisis following a fine-needle biopsy of hepatic metastasis.

Eur J Gastroenterol Hepatol 2009 Jan;21(1):101-3

Department of Nephrology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.

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http://dx.doi.org/10.1097/meg.0b013e328300c4f3DOI Listing
January 2009

Model-based drug development: the road to quantitative pharmacology.

J Pharmacokinet Pharmacodyn 2006 Jun 13;33(3):369-93. Epub 2006 Jun 13.

Bristol Myers-Squibb, Princeton, NJ, USA.

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http://dx.doi.org/10.1007/s10928-006-9010-8DOI Listing
June 2006

Pharmacokinetics/Pharmacodynamics and the stages of drug development: role of modeling and simulation.

AAPS J 2005 Oct 7;7(3):E544-59. Epub 2005 Oct 7.

Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN 46285, USA.

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http://dx.doi.org/10.1208/aapsj070355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751257PMC
October 2005

Clinical pharmacokinetics of alamifovir and its metabolites.

Antimicrob Agents Chemother 2005 May;49(5):1813-22

Lilly-NUS Centre for Clinical Pharmacology, Level 6 Clinical Research Centre, National University of Singapore, Singapore 117597, Republic of Singapore.

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http://aac.asm.org/content/49/5/1813.full.pdf
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http://aac.asm.org/cgi/doi/10.1128/AAC.49.5.1813-1822.2005
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http://dx.doi.org/10.1128/AAC.49.5.1813-1822.2005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1087642PMC
May 2005

Fluoxetine pharmacokinetics in pediatric patients.

J Clin Psychopharmacol 2002 Dec;22(6):568-75

Clinical Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA.

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http://dx.doi.org/10.1097/00004714-200212000-00006DOI Listing
December 2002