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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.
Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Polack FP, Zerbini C, Bailey R, Swanson KA, Xu X, Roychoudhury S, Koury K, Bouguermouh S, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Yang Q, Liberator P, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Gruber WC, Jansen KU; C4591001 Clinical Trial Group. Thomas SJ, et al. Among authors: roychoudhury s. N Engl J Med. 2021 Nov 4;385(19):1761-1773. doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15. N Engl J Med. 2021. PMID: 34525277 Free PMC article. Clinical Trial.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Polack FP, et al. Among authors: roychoudhury s. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10. N Engl J Med. 2020. PMID: 33301246 Free PMC article. Clinical Trial.
The Predictive Individual Effect for Survival Data.
Neuenschwander B, Roychoudhury S, Wandel S, Natarajan K, Zuber E. Neuenschwander B, et al. Among authors: roychoudhury s. Ther Innov Regul Sci. 2022 May;56(3):492-500. doi: 10.1007/s43441-022-00386-0. Epub 2022 Mar 16. Ther Innov Regul Sci. 2022. PMID: 35294767
Estimands in hematologic oncology trials.
Sun S, Weber HJ, Butler E, Rufibach K, Roychoudhury S. Sun S, et al. Among authors: roychoudhury s. Pharm Stat. 2021 Jul;20(4):793-805. doi: 10.1002/pst.2108. Epub 2021 Mar 8. Pharm Stat. 2021. PMID: 33686762
Use of historical control data for assessing treatment effects in clinical trials.
Viele K, Berry S, Neuenschwander B, Amzal B, Chen F, Enas N, Hobbs B, Ibrahim JG, Kinnersley N, Lindborg S, Micallef S, Roychoudhury S, Thompson L. Viele K, et al. Among authors: roychoudhury s. Pharm Stat. 2014 Jan-Feb;13(1):41-54. doi: 10.1002/pst.1589. Epub 2013 Aug 5. Pharm Stat. 2014. PMID: 23913901 Free PMC article. Review.
460 results