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Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.
Roberts SW, Elvang TLB, Syed L, Samuelsen MB, Arp-Hansen EL, Nielsen HK, Lund IK, Dünweber DL, Listov-Saabye N, Bjørn-Larsen D, Hjelmsmark A, Mikkelsen TA. Roberts SW, et al. Among authors: nielsen hk. Ther Innov Regul Sci. 2023 Mar;57(2):386-395. doi: 10.1007/s43441-022-00477-y. Epub 2022 Nov 18. Ther Innov Regul Sci. 2023. PMID: 36401076
Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.
Roberts SW, Elvang TLB, Syed L, Samuelsen MB, Arp-Hansen EL, Nielsen HK, Lund IK, Dünweber DL, Listov-Saabye N, Bjørn-Larsen D, Hjelmsmark A, Mikkelsen TA. Roberts SW, et al. Among authors: nielsen hk. Ther Innov Regul Sci. 2023 Mar;57(2):396-398. doi: 10.1007/s43441-022-00487-w. Ther Innov Regul Sci. 2023. PMID: 36472778 No abstract available.
Oral rivaroxaban for symptomatic venous thromboembolism.
EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. EINSTEIN Investigators, et al. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3. N Engl J Med. 2010. PMID: 21128814 Free article. Clinical Trial.
205 results