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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: brar s. 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.
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. Lee JY, et al. Among authors: brar s. Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000. Clin Pharmacokinet. 2011. PMID: 21895036
Time-Varying Clearance and Impact of Disease State on the Pharmacokinetics of Avelumab in Merkel Cell Carcinoma and Urothelial Carcinoma.
Wilkins JJ, Brockhaus B, Dai H, Vugmeyster Y, White JT, Brar S, Bello CL, Neuteboom B, Wade JR, Girard P, Khandelwal A. Wilkins JJ, et al. Among authors: brar s. CPT Pharmacometrics Syst Pharmacol. 2019 Jun;8(6):415-427. doi: 10.1002/psp4.12406. Epub 2019 Apr 25. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 30980481 Free PMC article.
U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.
Deisseroth A, Kaminskas E, Grillo J, Chen W, Saber H, Lu HL, Rothmann MD, Brar S, Wang J, Garnett C, Bullock J, Burke LB, Rahman A, Sridhara R, Farrell A, Pazdur R. Deisseroth A, et al. Among authors: brar s. Clin Cancer Res. 2012 Jun 15;18(12):3212-7. doi: 10.1158/1078-0432.CCR-12-0653. Epub 2012 Apr 27. Clin Cancer Res. 2012. PMID: 22544377
Food and oral antineoplastics: more than meets the eye.
Jain RK, Brar SS, Lesko LJ. Jain RK, et al. Among authors: brar ss. Clin Cancer Res. 2010 Sep 1;16(17):4305-7. doi: 10.1158/1078-0432.CCR-10-1857. Epub 2010 Aug 24. Clin Cancer Res. 2010. PMID: 20736331
586 results