Ni NiKhinMD

PubMed

• Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward.
  William P Horan, Dawn I Velligan, Richard S E Keefe, Florence Butlen-Ducuing, Philip D Harvey, Gary Sachs, Michael Davis, Ni A Khin> ;Innovations in Clinical Neuroscience. 2024 Mar 1
• Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines ...
  Kassa Ayalew, Yang-Min Ning, Michelle J Foringer, Susan Leibenhaut, Jenn W Sellers, Bei Yu, Phillip D Kronstein, Agata Higgerson, Camelia Mihaescu, Miguel Rodriguez, L...> ;Therapeutic Innovation & Regulatory Science. 2023 Jan 1
• Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
  Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A Khin> ;Therapeutic Innovation & Regulatory Science. 2022 Sep 1
• 1 citations
  Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
  Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A Khin> ;Therapeutic Innovation & Regulatory Science. 2022 Sep 1
• Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
  Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A Khin> ;Therapeutic Innovation & Regulatory Science. 2022 Sep 1
• 6 citations
  Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
  Ni A. Khin, Cheryl Grandinetti, Hayley Dixey, Bei Yu, Rachel Skeete, Kassa Ayalew, Mandy Budwal-Jagait, Seongeun-Julia Cho, Arindam Dasgupta, Andrew Fisher, Cynthia Kl...> ;Clinical Pharmacology and Therapeutics. 2021 Aug 30
• 11 citations
  Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinic...
  Ni A. Khin, Gail Francis, Jean Mulinde, Cheryl Grandinetti, Rachel Skeete, Bei Yu, Kassa Ayalew, Seongeun‐Julia Cho, Andrew Fisher, Cynthia Kleppinger, Ruben C. Ayala,...> ;Clinical Pharmacology and Therapeutics. 2020 Nov 1
• 1 citations
  Design considerations for handling dropouts in anti-depressant drug trials
  Jinglin Zhong, Ni A. Khin, Peiling Yang> ;Contemporary Clinical Trials. 2018 Feb 1
• 43 citations
  Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.
  Janice Kim, Harpreet Singh, Kassa Ayalew, Kristina Borror, Michelle Campbell, Laura Lee Johnson, Alyson Karesh, Ni A. Khin, Joanne R. Less, Jerry Menikoff, Lori Minasi...> ;Clinical Cancer Research. 2017 Dec 13
• 12 citations
  Considerations for the assessment of suicidal ideation and behavior in older adults with cognitive decline and dementia
  Larry Alphs, H. Robert Brashear, Phillip B. Chappell, Yeates Conwell, Sarah Dubrava, Ni A. Khin, Nicholas Kozauer, Dean M. Hartley, David S. Miller, Rachel Schindler, ...> ;Alzheimer's & Dementia. 2016 Jan 1
• 14 citations
  Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials
  Ni A. Khin, Phillip D. Kronstein, Peiling Yang, Eiji Ishida, H. M. James Hung, Mitchell V. Mathis, Ellis F. Unger, Robert Temple> ;The Journal of Clinical Psychiatry. 2015 Aug 26
• 48 citations
  Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration.
  Ni A. Khin, Yeh-Fong Chen, Yang Yang, Peiling Yang, Thomas Laughren> ;The Journal of Clinical Psychiatry. 2012 May 15
• 164 citations
  Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications.
  Ni A. Khin, Yeh-Fong Chen, Yang Yang, Peiling Yang, Thomas P. Laughren> ;The Journal of Clinical Psychiatry. 2011 Apr 15
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