Predictivity of non-clinical repolarization assay data for clinical TQT data in FDA database

被引：1

作者：

Valentin, Jean-Pierre ^{[1
]}

Koerner, John ^{[2
]}

Willard, James ^{[2
]}

Park, Eun Jung ^{[2
]}

Bi, Daoqin ^{[2
]}

Link, William ^{[2
]}

Fiszman, Monica ^{[2
]}

Kozeli, Devi ^{[2
]}

Skinner, Matt ^{[1
]}

Cantilena, Louis ^{[3
]}

Gintant, Gary ^{[4
]}

Wisialowski, Todd ^{[5
]}

Pettit, Syril ^{[6
]}

Vargas, Hugo ^{[7
]}

机构：

[1] AstraZeneca, Chesire, England

[2] US FDA, Silver Spring, MD USA

[3] Uniformed Serv Univ Hlth Sci, Bethesda, MD 20814 USA

[4] Abbott, Abbott Pk, IL USA

[5] Pfizer, New York, NY USA

[6] ILSI HESI, Washington, DC USA

[7] Amgen Inc, Thousand Oaks, CA USA

来源：

TOXICOLOGY LETTERS | 2013年 / 221卷

关键词：

D O I：

10.1016/j.toxlet.2013.05.566

中图分类号：

R99 [毒物学（毒理学）];

学科分类号：

100405 ;

摘要：

引用

页码：S232 / S233

页数：2

共 50 条

[31] ADRNet: A Generalized Collaborative Filtering Framework Combining Clinical and Non-Clinical Data for Adverse Drug Reaction Prediction
Li, Haoxuan
Hu, Taojun
Xiong, Zetong
Zheng, Chunyuan
Feng, Fuli
He, Xiangnan
Zhou, Xiao-Hua
[J]. PROCEEDINGS OF THE 17TH ACM CONFERENCE ON RECOMMENDER SYSTEMS, RECSYS 2023, 2023, : 682 - 687
[32] Just the way my brain works: capabilities for working with data in non-clinical practice
Sukovic, Suzana
[J]. JOURNAL OF DOCUMENTATION, 2024, 80 (02) : 487 - 507
[33] Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies
Mustonen, Enni-Kaisa
Palomaki, Tiina
Pasanen, Markku
[J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2017, 90 : 328 - 341
[34] Effects of QT-prolonging drugs on the non-clinical assay models: Comparison with clinical study
Sugiyama, Atsushi
Hoshiai, Kiyotaka
Nakamura, Yuji
Sakamoto, Kengo
Wakasa, Yoshio
Morikawa, Hiroshi
Hayashi, Takashi
Muto, Norio
Ulit, Ana Marie-V.
[J]. JOURNAL OF PHARMACOLOGICAL SCIENCES, 2008, 106 : 26P - 26P
[35] Detection and assay of β-lactamases in clinical and non-clinical strains of Yersinia enterocolitica biovar 1A
Sharma, S
Ramnani, P
Virdi, JS
[J]. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2004, 54 (02) : 401 - 405
[36] Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium
Park, Eunjung
Gintant, Gary A.
Bi, Daoqin
Kozeli, Devi
Pettit, Syril D.
Pierson, Jennifer B.
Skinner, Matthew
Willard, James
Wisialowski, Todd
Koerner, John
Valentin, Jean-Pierre
[J]. BRITISH JOURNAL OF PHARMACOLOGY, 2018, 175 (04) : 606 - 617
[37] The case of Francesco: clinical and non-clinical aspects
Bani, A.
[J]. JOURNAL OF PSYCHOPATHOLOGY-GIORNALE DI PSICOPATOLOGIA, 2012, 18 (04): : 309 - 314
[38] Emotional dysregulation in non-clinical and clinical subjects
Maffei, C.
Fossati, A.
Ponissi, V.
Bertoli, S.
Strepparava, M. G.
Borroni, S.
[J]. INTERNATIONAL JOURNAL OF PSYCHOPHYSIOLOGY, 2012, 85 (03) : 338 - 338
[39] Death anxiety in clinical and non-clinical groups
Abdel-Khalek, AM
[J]. DEATH STUDIES, 2005, 29 (03) : 251 - 259
[40] Flexibility for special clinical and non-clinical interests
Carelli, F
[J]. BRITISH JOURNAL OF GENERAL PRACTICE, 2004, 54 (509): : 947 - 948

← 1 2 3 4 5 →