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Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development.
Regev A, Avigan MI, Kiazand A, Vierling JM, Lewis JH, Omokaro SO, Di Bisceglie AM, Fontana RJ, Bonkovsky HL, Freston JW, Uetrecht JP, Miller ED, Pehlivanov ND, Haque SA, Harrison MJ, Kullak-Ublick GA, Li H, Patel NN, Patwardhan M, Price KD, Watkins PB, Chalasani NP. Regev A, et al. Among authors: li h. J Autoimmun. 2020 Nov;114:102514. doi: 10.1016/j.jaut.2020.102514. Epub 2020 Aug 5. J Autoimmun. 2020. PMID: 32768244 Free article. Review.
Neurologic Serious Adverse Events Associated with Nivolumab Plus Ipilimumab or Nivolumab Alone in Advanced Melanoma, Including a Case Series of Encephalitis.
Larkin J, Chmielowski B, Lao CD, Hodi FS, Sharfman W, Weber J, Suijkerbuijk KPM, Azevedo S, Li H, Reshef D, Avila A, Reardon DA. Larkin J, et al. Among authors: li h. Oncologist. 2017 Jun;22(6):709-718. doi: 10.1634/theoncologist.2016-0487. Epub 2017 May 11. Oncologist. 2017. PMID: 28495807 Free PMC article.
A contrast in safety, pharmacokinetics and pharmacodynamics across age groups after a single 50 mg oral dose of the γ-secretase inhibitor avagacestat.
Tong G, Wang JS, Sverdlov O, Huang SP, Slemmon R, Croop R, Castaneda L, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Dockens R. Tong G, et al. Among authors: li h. Br J Clin Pharmacol. 2013 Jan;75(1):136-45. doi: 10.1111/j.1365-2125.2012.04339.x. Br J Clin Pharmacol. 2013. PMID: 22616739 Free PMC article.
A placebo-controlled, multiple ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of avagacestat (BMS-708163) in healthy young and elderly subjects.
Dockens R, Wang JS, Castaneda L, Sverdlov O, Huang SP, Slemmon R, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Tong G. Dockens R, et al. Among authors: li h. Clin Pharmacokinet. 2012 Oct 1;51(10):681-93. doi: 10.1007/s40262-012-0005-x. Clin Pharmacokinet. 2012. PMID: 23018531 Clinical Trial.
Multicenter, randomized, double-blind, placebo-controlled, single-ascending dose study of the oral γ-secretase inhibitor BMS-708163 (Avagacestat): tolerability profile, pharmacokinetic parameters, and pharmacodynamic markers.
Tong G, Wang JS, Sverdlov O, Huang SP, Slemmon R, Croop R, Castaneda L, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Dockens RC. Tong G, et al. Among authors: li h. Clin Ther. 2012 Mar;34(3):654-67. doi: 10.1016/j.clinthera.2012.01.022. Epub 2012 Feb 28. Clin Ther. 2012. PMID: 22381714 Clinical Trial.
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