Zobrazeno 1 - 10
of 33
pro vyhledávání: '"NI A. KHIN"'
Autor:
HORAN, WILLIAM P., SACHS, GARY, VELLIGAN, DAWN I., DAVIS, MICHAEL, KEEFE, RICHARD S. E., NI A. KHIN, BUTLEN-DUCUING, FLORENCE, HARVEY, PHILIP D.
Publikováno v:
Innovations in Clinical Neuroscience; Jan-Mar2024, Vol. 21 Issue 1-3, p19-30, 12p
Publikováno v:
Cancer Biology & Medicine, Vol 15, Iss 1, Pp 1-5 (2018)
Externí odkaz:
https://doaj.org/article/709bbb7db9e8472283c7e81b1d1b0024
Autor:
Jenn W, Sellers, Camelia M, Mihaescu, Kassa, Ayalew, Phillip D, Kronstein, Bei, Yu, Yang-Min, Ning, Miguel, Rodriguez, LaKisha, Williams, Ni A, Khin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 56:753-764
Background The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for
Autor:
Phillip D. Kronstein, Jean Mulinde, Ni A. Khin, Seongeun-Julia Cho, Arindam Dasgupta, Cheryl Grandinetti, Gail Francis, Kassa Ayalew, Stephen Vinter, Jason Wakelin-Smith, Rachel Skeete, Bei Yu, Andrew Fisher, Paula Walker, Mandy Budwal-Jagait, Cynthia Kleppinger, Jennifer Martin, Michael McGuinness, Hayley Dixey
Publikováno v:
Clinical Pharmacology & Therapeutics. 112:31-43
With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug
Autor:
Kassa Ayalew, Yang-Min Ning, Michelle J. Foringer, Susan Leibenhaut, Jenn Sellers, Bei Yu, Phillip D. Kronstein, Agata Higgerson, Camelia Mihaescu, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
Background The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::57d6a76c14b31a947cc06ce510955afe
https://doi.org/10.21203/rs.3.rs-1667001/v1
https://doi.org/10.21203/rs.3.rs-1667001/v1
Autor:
Erica A, Smith, William P, Horan, Dominique, Demolle, Peter, Schueler, Dong-Jing, Fu, Ariana E, Anderson, Joseph, Geraci, Florence, Butlen-Ducuing, Jasmine, Link, Ni A, Khin, Robert, Morlock, Larry D, Alphs
Publikováno v:
Innov Clin Neurosci
The placebo response is a highly complex psychosocial-biological phenomenon that has challenged drug development for decades, particularly in neurological and psychiatric disease. While decades of research have aimed to understand clinical trial fact
Autor:
Bei Yu, Stephen Vinter, Phillip D. Kronstein, Rachel Skeete, Jean Mulinde, Cheryl Grandinetti, Arindam Dasgupta, Ruben C. Ayala, Seongeun‐Julia Cho, Ni A. Khin, Andrew Fisher, Gail Francis, Kassa Ayalew, Cynthia Kleppinger, Charles Bonapace
Publikováno v:
Clinical Pharmacology & Therapeutics. 108:949-963
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in cli
Autor:
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 56:765-766
Autor:
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 56:767-767
Publikováno v:
Cancer Biology & Medicine, Vol 15, Iss 1, Pp 1-5 (2018)
Cancer Biology & Medicine
Cancer Biology & Medicine