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Aggregate Safety Assessment Planning for the Drug Development Life-Cycle.
Hendrickson BA, Wang W, Ball G, Bennett D, Bhattacharyya A, Fries M, Kuebler J, Kurek R, McShea C, Tremmel L. Hendrickson BA, et al. Among authors: ball g. Ther Innov Regul Sci. 2021 Jul;55(4):717-732. doi: 10.1007/s43441-021-00271-2. Epub 2021 Mar 23. Ther Innov Regul Sci. 2021. PMID: 33755928
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. 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.
A sponsor must file an IND safety report for any serious unexpected suspected adverse reaction (SUSAR) of a medicinal product being investigated. Some events may be obviously drug-related (e.g., agranulocytosis, anaphylactic reaction, drug-induced hepatic injury, Stevens-J …
A sponsor must file an IND safety report for any serious unexpected suspected adverse reaction (SUSAR) of a medicinal product being investig …
Statistical Practices of Safety Monitoring: An Industry Survey.
Colopy MW, Gordon R, Ahmad F, Wang WW, Duke SP, Ball G. Colopy MW, et al. Among authors: ball g. Ther Innov Regul Sci. 2019 May;53(3):293-300. doi: 10.1177/2168479018779973. Epub 2018 Jul 10. Ther Innov Regul Sci. 2019. PMID: 29991276
1,224 results