Sinha V - Search Results

1

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

Wagner C, Pan Y, Hsu V, Grillo JA, Zhang L, Reynolds KS, Sinha V, Zhao P. Wagner C, et al. Among authors: sinha v. Clin Pharmacokinet. 2015 Jan;54(1):117-27. doi: 10.1007/s40262-014-0188-4. Clin Pharmacokinet. 2015. PMID: 25260695

2

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.

Wagner C, Zhao P, Pan Y, Hsu V, Grillo J, Huang SM, Sinha V. Wagner C, et al. Among authors: sinha v. CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30. doi: 10.1002/psp4.33. Epub 2015 Apr 17. CPT Pharmacometrics Syst Pharmacol. 2015. PMID: 26225246 Free PMC article.

3

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

Pan Y, Hsu V, Grimstein M, Zhang L, Arya V, Sinha V, Grillo JA, Zhao P. Pan Y, et al. Among authors: sinha v. J Clin Pharmacol. 2016 Jul;56 Suppl 7:S122-31. doi: 10.1002/jcph.740. J Clin Pharmacol. 2016. PMID: 27385170 Review.

4

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.

Wagner C, Pan Y, Hsu V, Sinha V, Zhao P. Wagner C, et al. Among authors: sinha v. Clin Pharmacokinet. 2016 Apr;55(4):475-83. doi: 10.1007/s40262-015-0330-y. Clin Pharmacokinet. 2016. PMID: 26369776

5

PBPK model describes the effects of comedication and genetic polymorphism on systemic exposure of drugs that undergo multiple clearance pathways.

Vieira MD, Kim MJ, Apparaju S, Sinha V, Zineh I, Huang SM, Zhao P. Vieira MD, et al. Among authors: sinha v. Clin Pharmacol Ther. 2014 May;95(5):550-7. doi: 10.1038/clpt.2014.43. Epub 2014 Feb 20. Clin Pharmacol Ther. 2014. PMID: 24556783

6

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

7

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

Jadhav PR, Cook J, Sinha V, Zhao P, Rostami-Hodjegan A, Sahasrabudhe V, Stockbridge N, Powell JR. Jadhav PR, et al. Among authors: sinha v. J Clin Pharmacol. 2015 Oct;55(10):1073-8. doi: 10.1002/jcph.579. Epub 2015 Jul 30. J Clin Pharmacol. 2015. PMID: 26109076

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

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.

10

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.

Mehrotra N, Bhattaram A, Earp JC, Florian J, Krudys K, Lee JE, Lee JY, Liu J, Mulugeta Y, Yu J, Zhao P, Sinha V. Mehrotra N, et al. Among authors: sinha v. Drug Metab Dispos. 2016 Jul;44(7):924-33. doi: 10.1124/dmd.116.069559. Epub 2016 Apr 14. Drug Metab Dispos. 2016. PMID: 27079249 Review.

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