Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation

Search Page

Filters

My NCBI Filters

Text availability

Article attribute

Article type

Publication date

Search Results

11,667 results

Filters applied: . Clear all
Results are displayed in a computed author sort order. The Results By Year timeline is not available.
Page 1
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Khin NA, Grandinetti C, Dixey H, Yu B, Skeete R, Ayalew K, Budwal-Jagait M, Cho SJ, Dasgupta A, Fisher A, Kleppinger C, Kronstein PD, Martin J, McGuinness M, Mulinde J, Vinter S, Wakelin-Smith J, Walker P, Francis G. Khin NA, et al. Among authors: yu b. Clin Pharmacol Ther. 2022 Jul;112(1):31-43. doi: 10.1002/cpt.2386. Epub 2021 Aug 30. Clin Pharmacol Ther. 2022. PMID: 34358334
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Khin NA, Francis G, Mulinde J, Grandinetti C, Skeete R, Yu B, Ayalew K, Cho SJ, Fisher A, Kleppinger C, Ayala R, Bonapace C, Dasgupta A, Kronstein PD, Vinter S. Khin NA, et al. Among authors: yu b. Clin Pharmacol Ther. 2020 Nov;108(5):949-963. doi: 10.1002/cpt.1794. Epub 2020 Mar 28. Clin Pharmacol Ther. 2020. PMID: 31958142
Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.
Ayalew K, Ning YM, Foringer MJ, Leibenhaut S, Sellers JW, Yu B, Kronstein PD, Higgerson A, Mihaescu C, Rodriguez M, Williams L, Khin NA. Ayalew K, et al. Among authors: yu b. Ther Innov Regul Sci. 2023 Jan;57(1):79-85. doi: 10.1007/s43441-022-00441-w. Epub 2022 Aug 16. Ther Innov Regul Sci. 2023. PMID: 35972722 Free PMC article.
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Sellers JW, Mihaescu CM, Ayalew K, Kronstein PD, Yu B, Ning YM, Rodriguez M, Williams L, Khin NA. Sellers JW, et al. Among authors: yu b. Ther Innov Regul Sci. 2022 Sep;56(5):765-766. doi: 10.1007/s43441-022-00423-y. Ther Innov Regul Sci. 2022. PMID: 35637424 Free PMC article. No abstract available.
Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.
Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I. Laughren TP, et al. Among authors: yu b. J Clin Psychiatry. 2011 Sep;72(9):1166-73. doi: 10.4088/JCP.11r06984. J Clin Psychiatry. 2011. PMID: 21951984 Review.
11,667 results
You have reached the last available page of results. Please see the User Guide for more information.