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Year Number of Results
2014 4
2017 7
2018 21
2019 37
2020 57
2021 65
2022 51
2023 15
2024 18

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237 results

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Page 1
Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis.
Walsh M, Merkel PA, Peh CA, Szpirt WM, Puéchal X, Fujimoto S, Hawley CM, Khalidi N, Floßmann O, Wald R, Girard LP, Levin A, Gregorini G, Harper L, Clark WF, Pagnoux C, Specks U, Smyth L, Tesar V, Ito-Ihara T, de Zoysa JR, Szczeklik W, Flores-Suárez LF, Carette S, Guillevin L, Pusey CD, Casian AL, Brezina B, Mazzetti A, McAlear CA, Broadhurst E, Reidlinger D, Mehta S, Ives N, Jayne DRW; PEXIVAS Investigators. Walsh M, et al. N Engl J Med. 2020 Feb 13;382(7):622-631. doi: 10.1056/NEJMoa1803537. N Engl J Med. 2020. PMID: 32053298 Free PMC article. Clinical Trial.
A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.
Cocoros NM, Fuller CC, Adimadhyam S, Ball R, Brown JS, Dal Pan GJ, Kluberg SA, Lo Re V 3rd, Maro JC, Nguyen M, Orr R, Paraoan D, Perlin J, Poland RE, Driscoll MR, Sands K, Toh S, Yih WK, Platt R; And the FDA-Sentinel COVID-19 Working Group. Cocoros NM, et al. Pharmacoepidemiol Drug Saf. 2021 Jul;30(7):827-837. doi: 10.1002/pds.5240. Epub 2021 Apr 18. Pharmacoepidemiol Drug Saf. 2021. PMID: 33797815 Free PMC article. Review.
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. ...
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for i …
The US Food and Drug Administration Sentinel System: a national resource for a learning health system.
Brown JS, Mendelsohn AB, Nam YH, Maro JC, Cocoros NM, Rodriguez-Watson C, Lockhart CM, Platt R, Ball R, Dal Pan GJ, Toh S. Brown JS, et al. J Am Med Inform Assoc. 2022 Nov 14;29(12):2191-2200. doi: 10.1093/jamia/ocac153. J Am Med Inform Assoc. 2022. PMID: 36094070 Free PMC article.
The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 that the agency establish a system for monitoring risks associated with drug and biologic products using data from disparate sources. ...
The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 …
Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.
Corneli A, Dombeck CB, McKenna K, Calvert SB. Corneli A, et al. Ethics Hum Res. 2021 May;43(3):26-36. doi: 10.1002/eahr.500092. Ethics Hum Res. 2021. PMID: 34019339 Free PMC article.
The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. ...
The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Fo …
Pharmacoethics and pregnancy: Overcoming the therapeutic orphan stigma.
Kazma JM, Van Den Anker J, Ahmadzia HK. Kazma JM, et al. Br J Clin Pharmacol. 2023 Feb;89(2):483-490. doi: 10.1111/bcp.15173. Epub 2022 Jan 5. Br J Clin Pharmacol. 2023. PMID: 34904271 Free article. Review.
Pregnancy can be complicated by multiple comorbidities that require pharmacological intervention; these interventions primarily target the pregnant woman but also sometimes have secondary effects for the foetus. The US Food and Drug Administration has issued multiple guida …
Pregnancy can be complicated by multiple comorbidities that require pharmacological intervention; these interventions primarily target the p …
Technologies for Detection of Babesia microti: Advances and Challenges.
Meredith S, Oakley M, Kumar S. Meredith S, et al. Pathogens. 2021 Nov 30;10(12):1563. doi: 10.3390/pathogens10121563. Pathogens. 2021. PMID: 34959518 Free PMC article. Review.
This review article will discuss the historical perspective and current status of technologies for the detection of Babesia microti, the most common Babesia species causing human babesiosis in the United States, and their implications for early diagnosis of acute ba …
This review article will discuss the historical perspective and current status of technologies for the detection of Babesia microti, the mos …
Deep learning in medical imaging and radiation therapy.
Sahiner B, Pezeshk A, Hadjiiski LM, Wang X, Drukker K, Cha KH, Summers RM, Giger ML. Sahiner B, et al. Med Phys. 2019 Jan;46(1):e1-e36. doi: 10.1002/mp.13264. Epub 2018 Nov 20. Med Phys. 2019. PMID: 30367497 Free PMC article. Review.
Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval.
Strauss DG, Wang YM, Florian J, Zineh I. Strauss DG, et al. Clin Pharmacol Ther. 2023 Jan;113(1):55-61. doi: 10.1002/cpt.2761. Epub 2022 Nov 2. Clin Pharmacol Ther. 2023. PMID: 36178447 Free PMC article. Review.
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from a US Food and Drug Administration (FDA)-approved reference product. The development and approval of biosimilars is critical to enhancing the availability of saf …
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from a US Food and Drug A …
237 results