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Items: 11

1.

Role of Model-Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling.

Bi Y, Liu J, Li L, Yu J, Bhattaram A, Bewernitz M, Li RJ, Liu C, Earp J, Ma L, Zhuang L, Yang Y, Zhang X, Zhu H, Wang Y.

J Clin Pharmacol. 2019 Sep;59 Suppl 1:S104-S111. doi: 10.1002/jcph.1478.

PMID:
31502691
2.

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.

Drug Metab Dispos. 2016 Jul;44(7):924-33. doi: 10.1124/dmd.116.069559. Epub 2016 Apr 14. Review.

PMID:
27079249
3.

Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease.

Stephenson D, Hu MT, Romero K, Breen K, Burn D, Ben-Shlomo Y, Bhattaram A, Isaac M, Venuto C, Kubota K, Little MA, Friend S, Lovestone S, Morris HR, Grosset D, Sutherland M, Gallacher J, Williams-Gray C, Bain LJ, Avil├ęs E, Marek K, Toga AW, Stark Y, Forrest Gordon M, Ford S.

J Parkinsons Dis. 2015;5(3):581-94. doi: 10.3233/JPD-150570.

4.

Is this the dose for you?: the role of modeling.

Huang SM, Bhattaram A, Mehrotra N, Wang Y.

Clin Pharmacol Ther. 2013 Feb;93(2):159-62. doi: 10.1038/clpt.2012.228. Epub 2012 Nov 19.

PMID:
23281423
5.

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
6.

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
7.

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
8.

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
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