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, Ni A, Francis, Gail, Mulinde, Jean, Grandinetti, Cheryl, Skeete, Rachel, Yu, Bei, Ayalew, Kassa, Cho, Seongeun-Julia, Fisher, Andrew, Kleppinger, Cynthia, Ayala, Ruben, Bonapace, Charles, Dasgupta, Arindam, Kronstein, Phillip D, Vinter, Stephen
Published in Clinical pharmacology and therapeutics (01.11.2020)
Published in Clinical pharmacology and therapeutics (01.11.2020)
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Journal Article
Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Published in Therapeutic innovation & regulatory science (01.09.2022)
Published in Therapeutic innovation & regulatory science (01.09.2022)
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Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Published in Therapeutic innovation & regulatory science (01.09.2022)
Published in Therapeutic innovation & regulatory science (01.09.2022)
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Summary of findings from the FDA regulatory science forum on measuring sexual dysfunction in depression trials
Kronstein, Phillip D, Ishida, Eiji, Khin, Ni A, Chang, Eric, Hung, H M James, Temple, Robert J, Yang, Peiling
Published in The journal of clinical psychiatry (01.08.2015)
Published in The journal of clinical psychiatry (01.08.2015)
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Journal Article
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Published in Therapeutic innovation & regulatory science (01.09.2022)
Published in Therapeutic innovation & regulatory science (01.09.2022)
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Regulatory and scientific issues in studies to evaluate sexual dysfunction in antidepressant drug trials
Khin, Ni A, Kronstein, Phillip D, Yang, Peiling, Ishida, Eiji, Hung, H M James, Mathis, Mitchell V, Unger, Ellis F, Temple, Robert J
Published in The journal of clinical psychiatry (01.08.2015)
Published in The journal of clinical psychiatry (01.08.2015)
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Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency
Ayalew, Kassa, Ning, Yang-Min, Foringer, Michelle J., Leibenhaut, Susan, Sellers, Jenn W., Yu, Bei, Kronstein, Phillip D., Higgerson, Agata, Mihaescu, Camelia, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Published in Therapeutic innovation & regulatory science (01.01.2023)
Published in Therapeutic innovation & regulatory science (01.01.2023)
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The United States Food and Drug Administration’s Innovative Alternative Tools to Evaluate Good Clinical Practice During the COVID-19 Public Health Emergency
Ayalew, Kassa, Sellers, Jenn, Kronstein, Phillip D., Muldowney, Laurie, Gebbia, Emily, Mulinde, Jean, Burrow, David
Published in Journal of the Society for Clinical Data Management (10.02.2023)
Published in Journal of the Society for Clinical Data Management (10.02.2023)
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The acute treatment of bipolar depression: Historically relevant and recent controlled trials
Kronstein, Philip D., Zarate, Carlos A.
Published in Current psychosis & therapeutics reports (01.12.2006)
Published in Current psychosis & therapeutics reports (01.12.2006)
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