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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: syed l. 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: syed l. 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.
GP wellbeing is more than a tick box exercise.
Syed L, Sornalingam S, Cooper M. Syed L, et al. Br J Gen Pract. 2023 May 25;73(731):255. doi: 10.3399/bjgp23X732969. Print 2023 Jun. Br J Gen Pract. 2023. PMID: 37230789 Free PMC article. No abstract available.
Outcomes of Tyrosine Kinase Inhibitors Maintenance Therapy with or without Allogeneic Hematopoietic Stem Cell Transplantation in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in First Complete Remission: A Systematic Review and Meta-Analysis.
Shahzad M, Hussain A, Tariq E, Anwar I, Faisal MS, Syed L, Karam A, Chaudhary SG, Ahmed N, Bansal R, Khurana S, Singh AK, Byrd KP, Hematti P, Abhyankar SH, McGuirk JP, Mushtaq MU. Shahzad M, et al. Among authors: syed l. Clin Lymphoma Myeloma Leuk. 2023 Mar;23(3):178-187. doi: 10.1016/j.clml.2023.01.002. Epub 2023 Jan 12. Clin Lymphoma Myeloma Leuk. 2023. PMID: 36682989 Review.
43 results