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Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center.
Desai RJ, Wang SV, Sreedhara SK, Zabotka L, Khosrow-Khavar F, Nelson JC, Shi X, Toh S, Wyss R, Patorno E, Dutcher S, Li J, Lee H, Ball R, Dal Pan G, Segal JB, Suissa S, Rothman KJ, Greenland S, Hernán MA, Heagerty PJ, Schneeweiss S. Desai RJ, et al. Among authors: dal pan g. BMJ. 2024 Feb 12;384:e076460. doi: 10.1136/bmj-2023-076460. BMJ. 2024. PMID: 38346815 No abstract available.
Enhancing Postmarketing Surveillance of Medical Products With Large Language Models.
Matheny ME, Yang J, Smith JC, Walsh CG, Al-Garadi MA, Davis SE, Marsolo KA, Fabbri D, Reeves RR, Johnson KB, Dal Pan GJ, Ball R, Desai RJ. Matheny ME, et al. Among authors: dal pan gj. JAMA Netw Open. 2024 Aug 1;7(8):e2428276. doi: 10.1001/jamanetworkopen.2024.28276. JAMA Netw Open. 2024. PMID: 39150707 Free article.
Removing the FDA's Boxed Hepatotoxicity Warning and Liver Function Testing Requirement for Ambrisentan.
Feldman WB, Mahesri M, Sarpatwari A, Huybrechts KF, Zhu Y, Hwang CS, Lii J, Lee SB, Kattinakere Sreedhara S, Toyserkani GA, Zhou EH, Zendel L, LaCivita C, Manzo C, Dal Pan GJ, Kesselheim AS, Bykov K. Feldman WB, et al. Among authors: dal pan gj. JAMA Netw Open. 2024 Jul 1;7(7):e2419873. doi: 10.1001/jamanetworkopen.2024.19873. JAMA Netw Open. 2024. PMID: 39023895 Free PMC article.
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000-2020.
Mahesri M, Sarpatwari A, Huybrechts KF, Lii J, Lee SB, Toyserkani GA, LaCivita C, Zhou EH, Dal Pan GJ, Kesselheim AS, Bykov K. Mahesri M, et al. Among authors: dal pan gj. Drug Saf. 2024 Sep;47(9):909-919. doi: 10.1007/s40264-024-01443-3. Epub 2024 May 16. Drug Saf. 2024. PMID: 38755509
When can real-world data generate real-world evidence?
Rahman M, Dal Pan G, Stein P, Levenson M, Kraus S, Chakravarty A, Rivera DR, Forshee R, Concato J. Rahman M, et al. Among authors: dal pan g. Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):e5715. doi: 10.1002/pds.5715. Epub 2023 Oct 19. Pharmacoepidemiol Drug Saf. 2024. PMID: 37855046 No abstract available.
105 results