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Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.
Ball G, Kurek R, Hendrickson BA, Buchanan J, Wang WW, Duke SP, Bhattacharyya A, Li M, O'Brien D, Weigel J, Wang W, Jiang Q, Ahmad F, Seltzer JH, Herrero-Martinez E, Tremmel L. Ball G, et al. Among authors: buchanan j. Ther Innov Regul Sci. 2020 Mar;54(2):447-461. doi: 10.1007/s43441-019-00076-4. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32072595 Free PMC article.
Interdisciplinary Safety Evaluation for Learning and Decision-Making.
Ball G, Hendrickson BA, Freedman AL, Gordon R, Crowe B, Veenhuizen MF, Buchanan J. Ball G, et al. Among authors: buchanan j. Ther Innov Regul Sci. 2021 Jul;55(4):705-716. doi: 10.1007/s43441-021-00268-x. Epub 2021 Mar 17. Ther Innov Regul Sci. 2021. PMID: 33730364 Review.
Aggregate IND Safety Reporting for Smaller Companies and Programs.
Ball G, Li M, Buchanan J, Hendrickson B, Zink RC, Snapinn S, Herson J. Ball G, et al. Among authors: buchanan j. Ther Innov Regul Sci. 2024 Mar;58(2):368-379. doi: 10.1007/s43441-023-00605-2. Epub 2024 Jan 8. Ther Innov Regul Sci. 2024. PMID: 38190028
Paving the path for implementation of clinical genomic sequencing globally: Are we ready?
Marshall DA, Hua N, Buchanan J, Christensen KD, Frederix GWJ, Goranitis I, Ijzerman M, Jansen JP, Lavelle TA, Regier DA, Smith HS, Ungar WJ, Weymann D, Wordsworth S, Phillips KA. Marshall DA, et al. Among authors: buchanan j. Health Aff Sch. 2024 Apr 29;2(5):qxae053. doi: 10.1093/haschl/qxae053. eCollection 2024 May. Health Aff Sch. 2024. PMID: 38783891 Free PMC article.
1,570 results