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Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.
Hotaki LT, Shrestha A, Bennett MP, Valdes IL, Lee SH, Wang Y, Spillman D, MacAulay T, Hunt M, Gervais J, Mafi M, Panetta V, Looi YH, Shum M, Atiek E, Meincke R, Rohr UP, Ainbinder D, Boehm-Cagan A, Luxenburg O, Cerqueira MR, Mouawad LS, Thees MFRES, Prasad K, de Claro RA. Hotaki LT, et al. Among authors: de claro ra. Ther Innov Regul Sci. 2023 Jul;57(4):875-885. doi: 10.1007/s43441-023-00522-4. Epub 2023 Apr 18. Ther Innov Regul Sci. 2023. PMID: 37072651 Review.
Differences in F36VMpl-based in vivo selection among large animal models.
Richard RE, De Claro RA, Yan J, Chien S, Von Recum H, Morris J, Kiem HP, Dalgarno DC, Heimfeld S, Clackson T, Andrews R, Blau CA. Richard RE, et al. Among authors: de claro ra. Mol Ther. 2004 Oct;10(4):730-40. doi: 10.1016/j.ymthe.2004.07.005. Mol Ther. 2004. PMID: 15451457 Free article.
Dose Finding in Late-Phase Drug Development.
Nie L, Lee KY, Verdun N, De Claro RA, Sridhara R. Nie L, et al. Among authors: de claro ra. Ther Innov Regul Sci. 2017 Nov;51(6):738-743. doi: 10.1177/2168479017709297. Epub 2017 May 30. Ther Innov Regul Sci. 2017. PMID: 30227101
Project Orbis: Global Collaborative Review Program.
de Claro RA, Spillman D, Hotaki LT, Shum M, Mouawad LS, Santos GML, Robinson K, Hunt M, Healy C, Chan A, Looi YH, Rodrigues C, Rohr UP, Walther C, Pazdur R. de Claro RA, et al. Clin Cancer Res. 2020 Dec 15;26(24):6412-6416. doi: 10.1158/1078-0432.CCR-20-3292. Epub 2020 Oct 9. Clin Cancer Res. 2020. PMID: 33037016
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review.
Vellanki PJ, Mulkey F, Jaigirdar AA, Rodriguez L, Wang Y, Xu Y, Zhao H, Liu J, Howe G, Wang J, Choo Q, Golding SJ, Mansell V, Korsah K, Spillman D, de Claro RA, Pazdur R, Beaver JA, Singh H. Vellanki PJ, et al. Among authors: de claro ra. Clin Cancer Res. 2021 Jul 1;27(13):3522-3527. doi: 10.1158/1078-0432.CCR-20-4338. Epub 2021 Feb 25. Clin Cancer Res. 2021. PMID: 33632925 Free PMC article. Clinical Trial.
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Amatya AK, et al. Among authors: de claro ra. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. Clin Cancer Res. 2021. PMID: 34117032 Free PMC article. Review.
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