Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections
Kim, Janice, Singh, Harpreet, Ayalew, Kassa, Borror, Kristina, Campbell, Michelle, Johnson, Laura Lee, Karesh, Alyson, Khin, Ni A, Less, Joanne R, Menikoff, Jerry, Minasian, Lori, Mitchell, Sandra A, Papadopoulos, Elektra J, Piekarz, Richard L, Prohaska, Kevin A, Thompson, Susan, Sridhara, Rajeshwari, Pazdur, Richard, Kluetz, Paul G
Published in Clinical cancer research (15.04.2018)
Published in Clinical cancer research (15.04.2018)
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Neuropsychiatric symptoms in Alzheimer's disease: Past progress and anticipation of the future
Geda, Yonas E, Schneider, Lon S, Gitlin, Laura N, Miller, David S, Smith, Gwenn S, Bell, Joanne, Evans, Jovier, Lee, Michael, Porsteinsson, Anton, Lanctôt, Krista L, Rosenberg, Paul B, Sultzer, David L, Francis, Paul T, Brodaty, Henry, Padala, Prasad P, Onyike, Chiadikaobi U, Ortiz, Luis Agüera, Ancoli-Israel, Sonia, Bliwise, Donald L, Martin, Jennifer L, Vitiello, Michael V, Yaffe, Kristine, Zee, Phyllis C, Herrmann, Nathan, Sweet, Robert A, Ballard, Clive, Khin, Ni A, Alfaro, Cara, Murray, Patrick S, Schultz, Susan, Lyketsos, Constantine G
Published in Alzheimer's & dementia (01.09.2013)
Published in Alzheimer's & dementia (01.09.2013)
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Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications
Khin, Ni A, Chen, Yeh-Fong, Yang, Yang, Yang, Peiling, Laughren, Thomas P
Published in The journal of clinical psychiatry (01.04.2011)
Published in The journal of clinical psychiatry (01.04.2011)
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Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration
Borges, Silvana, Chen, Yeh-Fong, Laughren, Thomas P, Temple, Robert, Patel, Hiren D, David, Paul A, Mathis, Mitchell, Unger, Ellis, Yang, Peiling, Khin, Ni A
Published in The journal of clinical psychiatry (01.03.2014)
Published in The journal of clinical psychiatry (01.03.2014)
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Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration
Khin, Ni A, Chen, Yeh-Fong, Yang, Yang, Yang, Peiling, Laughren, Thomas P
Published in The journal of clinical psychiatry (01.06.2012)
Published in The journal of clinical psychiatry (01.06.2012)
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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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Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward
Horan, William P, Sachs, Gary, Velligan, Dawn I, Davis, Michael, Keefe, Richard S E, Khin, Ni A, Butlen-Ducuing, Florence, Harvey, Philip D
Published in Innovations in clinical neuroscience (01.01.2024)
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Published in Innovations in clinical neuroscience (01.01.2024)
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Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials
Smith, Erica A, Horan, William P, Demolle, Dominique, Schueler, Peter, Fu, Dong-Jing, Anderson, Ariana E, Geraci, Joseph, Butlen-Ducuing, Florence, Link, Jasmine, Khin, Ni A, Morlock, Robert, Alphs, Larry D
Published in Innovations in clinical neuroscience (01.01.2022)
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Published in Innovations in clinical neuroscience (01.01.2022)
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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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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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Considerations for the assessment of suicidal ideation and behavior in older adults with cognitive decline and dementia
Alphs, Larry, Brashear, H. Robert, Chappell, Phillip, Conwell, Yeates, Dubrava, Sarah, Khin, Ni A, Kozauer, Nicholas, Hartley, Dean M, Miller, David S, Schindler, Rachel J, Siemers, Eric R, Stewart, Michelle, Yaffe, Kristine
Published in Alzheimer's & dementia : translational research & clinical interventions (01.01.2016)
Published in Alzheimer's & dementia : translational research & clinical interventions (01.01.2016)
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Clinical description of an adult male with psychosis who showed FMR1 gene methylation mosaicism
Khin, N A, Tarleton, J, Raghu, B, Park, S K
Published in American journal of medical genetics (08.05.1998)
Published in American journal of medical genetics (08.05.1998)
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ADHD and thyroid dysfunction
Leo, R J, Khin, N A, Cohen, G N
Published in Journal of the American Academy of Child and Adolescent Psychiatry (01.12.1996)
Published in Journal of the American Academy of Child and Adolescent Psychiatry (01.12.1996)
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