Sinha V - Search Results

1

Leveraging Big Data in Pediatric Development Programs: Proceedings From the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.

Mulugeta LY, Yao L, Mould D, Jacobs B, Florian J, Smith B, Sinha V, Barrett JS. Mulugeta LY, et al. Among authors: sinha v. Clin Pharmacol Ther. 2018 Jul;104(1):81-87. doi: 10.1002/cpt.975. Epub 2018 Jan 10. Clin Pharmacol Ther. 2018. PMID: 29319159

2

Direct-acting antiviral drugs for the treatment of chronic hepatitis C virus infection: Interferon free is now.

Florian J, Mishra P, Arya V, Harrington P, Connelly S, Reynolds KS, Sinha V. Florian J, et al. Among authors: sinha v. Clin Pharmacol Ther. 2015 Oct;98(4):394-402. doi: 10.1002/cpt.185. Epub 2015 Aug 31. Clin Pharmacol Ther. 2015. PMID: 26179495 Review.

3

Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting.

Momper JD, Heinrichs MT, Krudys K, Griebel D, Kumar S, Kim I, Mehrotra N, Mulberg AE, Garimella N, Nelson R, Reaman G, Sinha V, Yao L, Zineh I, Burckart G, Sachs H, Mulugeta Y. Momper JD, et al. Among authors: sinha v. J Clin Pharmacol. 2020 Jun;60(6):775-784. doi: 10.1002/jcph.1577. Epub 2020 Jan 22. J Clin Pharmacol. 2020. PMID: 31967340

4

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

Mulugeta YL, Zajicek A, Barrett J, Sachs HC, McCune S, Sinha V, Yao L. Mulugeta YL, et al. Among authors: sinha v. Pediatr Clin North Am. 2017 Dec;64(6):1185-1196. doi: 10.1016/j.pcl.2017.08.015. Pediatr Clin North Am. 2017. PMID: 29173779 Free PMC article. Review.

5

Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.

Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagao L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Galluppi GR, et al. Among authors: sinha v. Clin Pharmacol Ther. 2021 Nov;110(5):1172-1175. doi: 10.1002/cpt.2265. Epub 2021 May 15. Clin Pharmacol Ther. 2021. PMID: 33991429 Free PMC article. Review. No abstract available.

6

Pivotal Dose of Pembrolizumab: A Dose-Finding Strategy for Immuno-Oncology.

Li TR, Chatterjee M, Lala M, Abraham AK, Freshwater T, Jain L, Sinha V, de Alwis DP, Mayawala K. Li TR, et al. Among authors: sinha v. Clin Pharmacol Ther. 2021 Jul;110(1):200-209. doi: 10.1002/cpt.2170. Epub 2021 Mar 8. Clin Pharmacol Ther. 2021. PMID: 33462831

7

Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy.

Sinha V, Zhao P, Huang SM, Zineh I. Sinha V, et al. Clin Pharmacol Ther. 2014 May;95(5):478-80. doi: 10.1038/clpt.2014.46. Clin Pharmacol Ther. 2014. PMID: 24747236

8

Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop.

Younis IR, Robert Powell J, Rostami-Hodjegan A, Corrigan B, Stockbridge N, Sinha V, Zhao P, Jadhav P, Flamion B, Cook J. Younis IR, et al. Among authors: sinha v. J Clin Pharmacol. 2017 Jan;57(1):105-109. doi: 10.1002/jcph.787. Epub 2016 Sep 5. J Clin Pharmacol. 2017. PMID: 27365151

9

Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism.

Khurana M, Zadezensky I, Lowy N, Roman D, Guettier JM, Li L, Florian J, Sahajwalla CG, Sinha V, Mehrotra N. Khurana M, et al. Among authors: sinha v. Clin Pharmacol Ther. 2019 Mar;105(3):710-718. doi: 10.1002/cpt.1200. Epub 2018 Oct 22. Clin Pharmacol Ther. 2019. PMID: 30350311

10

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

Li L, Ma L, Schrieber SJ, Rahman NA, Deisseroth A, Farrell AT, Wang Y, Sinha V, Marathe A. Li L, et al. Among authors: sinha v. Clin Pharmacol Ther. 2018 Oct;104(4):742-748. doi: 10.1002/cpt.991. Epub 2018 Feb 2. Clin Pharmacol Ther. 2018. PMID: 29392707

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