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Page 1
Towards early inclusion of children in tuberculosis drugs trials: a consensus statement.
Nachman S, Ahmed A, Amanullah F, Becerra MC, Botgros R, Brigden G, Browning R, Gardiner E, Hafner R, Hesseling A, How C, Jean-Philippe P, Lessem E, Makhene M, Mbelle N, Marais B, McIlleron H, McNeeley DF, Mendel C, Murray S, Navarro E, Anyalechi EG, Porcalla AR, Powell C, Powell M, Rigaud M, Rouzier V, Samson P, Schaaf HS, Shah S, Starke J, Swaminathan S, Wobudeya E, Worrell C. Nachman S, et al. Among authors: porcalla ar. Lancet Infect Dis. 2015 Jun;15(6):711-20. doi: 10.1016/S1473-3099(15)00007-9. Epub 2015 May 6. Lancet Infect Dis. 2015. PMID: 25957923 Free PMC article. Review.
Extrapolation as a Default Strategy in Pediatric Drug Development.
Gamalo M, Bucci-Rechtweg C, Nelson RM, Vanh L, Porcalla A, Thackray H, Cooner F, Cutler L, Friend D, Portman R. Gamalo M, et al. Ther Innov Regul Sci. 2022 Nov;56(6):883-894. doi: 10.1007/s43441-021-00367-9. Epub 2022 Jan 10. Ther Innov Regul Sci. 2022. PMID: 35006587
Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial.
Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Asselah T, et al. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2. Lancet Gastroenterol Hepatol. 2019. PMID: 30393106 Clinical Trial.
Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study.
Jonas MM, Squires RH, Rhee SM, Lin CW, Bessho K, Feiterna-Sperling C, Hierro L, Kelly D, Ling SC, Strokova T, Del Valle-Segarra A, Lovell S, Liu W, Ng TI, Porcalla A, Gonzalez YS, Burroughs M, Sokal E. Jonas MM, et al. Hepatology. 2020 Feb;71(2):456-462. doi: 10.1002/hep.30840. Epub 2019 Aug 13. Hepatology. 2020. PMID: 31254392 Free PMC article. Clinical Trial.
Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.
Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Wörns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Gane E, et al. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022. Clin Infect Dis. 2019. PMID: 30923816 Free PMC article. Clinical Trial.
Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection.
Reau N, Kwo PY, Rhee S, Brown RS Jr, Agarwal K, Angus P, Gane E, Kao JH, Mantry PS, Mutimer D, Reddy KR, Tran TT, Hu YB, Gulati A, Krishnan P, Dumas EO, Porcalla A, Shulman NS, Liu W, Samanta S, Trinh R, Forns X. Reau N, et al. Hepatology. 2018 Oct;68(4):1298-1307. doi: 10.1002/hep.30046. Epub 2018 Jul 25. Hepatology. 2018. PMID: 29672891 Free PMC article. Clinical Trial.
13 results