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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: kleppinger c. 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: kleppinger c. Clin Pharmacol Ther. 2020 Nov;108(5):949-963. doi: 10.1002/cpt.1794. Epub 2020 Mar 28. Clin Pharmacol Ther. 2020. PMID: 31958142
Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation.
Rothstein E, Kohl KS, Ball L, Halperin SA, Halsey N, Hammer SJ, Heath PT, Hennig R, Kleppinger C, Labadie J, Varricchio F, Vermeer P, Walop W; Brighton Collaboration Local Reaction Working Group. Rothstein E, et al. Among authors: kleppinger c. Vaccine. 2004 Jan 26;22(5-6):575-85. doi: 10.1016/j.vaccine.2003.09.005. Vaccine. 2004. PMID: 14741147 Review. No abstract available.
Developing new smallpox vaccines.
Rosenthal SR, Merchlinsky M, Kleppinger C, Goldenthal KL. Rosenthal SR, et al. Among authors: kleppinger c. Emerg Infect Dis. 2001 Nov-Dec;7(6):920-6. doi: 10.3201/eid0706.010602. Emerg Infect Dis. 2001. PMID: 11747717 Free PMC article.