SELECTION OF THE TIME POINTS FOR A THOROUGH QTC STUDY

被引:0
|
作者
Zhang, Joanne [1 ]
Stockbridge, Norman [2 ]
机构
[1] US FDA, Div Biometr 6, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
[2] US FDA, Div Cardiovasc & Renal Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
来源
DRUG INFORMATION JOURNAL | 2011年 / 45卷 / 06期
关键词
MOXIFLOXACIN;
D O I
10.1177/009286151104500506
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
引用
收藏
页码:713 / 715
页数:3
相关论文
共 50 条
  • [41] Bupivacaine Extended Release Liposome Injection Does Not Prolong QTc Interval in a Thorough QT/QTc Study in Healthy Volunteers
    Naseem, Asif
    Harada, Tomohiko
    Wang, Duolao
    Arezina, Radivoj
    Lorch, Ulrike
    Onel, Erol
    Camm, Alan John
    Taubel, Jorg
    JOURNAL OF CLINICAL PHARMACOLOGY, 2012, 52 (09): : 1441 - 1447
  • [42] Thorough QT/QTc study to evaluate the effect of a single supratherapeutic dose of islatravir on QTc interval prolongation in healthy adults
    Matthews, Randolph P.
    Liu, Yang
    Matthews, Catherine
    Butterfield, Kristin L.
    O'Reilly, Terry
    Stoch, S. Aubrey
    Iwamoto, Marian
    ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2024, 68 (08)
  • [43] Electrocardiographic Data Quality in Thorough QT/QTc Studies
    Johannesen, Lars
    Garnett, Christine
    Malik, Marek
    DRUG SAFETY, 2014, 37 (03) : 191 - 197
  • [44] Electrocardiographic Data Quality in Thorough QT/QTc Studies
    Lars Johannesen
    Christine Garnett
    Marek Malik
    Drug Safety, 2014, 37 : 191 - 197
  • [45] Validation testing in thorough QT/QTc clinical trials
    Tsong, Yi
    Zhong, Jinglin
    Chen, Wen Jen
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2008, 18 (03) : 529 - 541
  • [46] Limb Lead Interchange in Thorough QT/QTc Studies
    Salvi, Vaibhav
    Karnad, Dilip R.
    Panicker, Gopi Krishna
    Kothari, Snehal
    Hingorani, Pooja
    Natekar, Mili
    Mahajan, Vaibhav
    Narula, Dhiraj
    JOURNAL OF CLINICAL PHARMACOLOGY, 2011, 51 (10): : 1468 - 1473
  • [47] Thorough QT Studies and Indirect Causes of QTc Changes
    Malik, Marek
    Stockbridge, Norman
    PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 2012, 35 (12): : 1411 - 1412
  • [48] Effects of Sugammadex Doses up to 32 mg/kg Alone or in Combination with Rocuronium or Vecuronium on QTc Prolongation A Thorough QTc Study
    de Kam, Pieter-Jan
    van Kuijk, Jacqueline
    Prohn, Marita
    Thomsen, Torben
    Peeters, Pierre
    CLINICAL DRUG INVESTIGATION, 2010, 30 (09) : 599 - 611
  • [49] A thorough QT/QTc study of multiple doses of tapentadol immediate release in healthy subjects
    Oh, C.
    Rengelshausen, J.
    Mangold, B.
    Etropolski, M.
    Rauschkolb, C.
    Wang, S. S.
    Upmalis, D.
    Haeufel, T.
    INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, 2010, 48 (10) : 678 - 687
  • [50] Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants
    Gabe, Maria B. N.
    Fuhr, Rainard
    Sinn, Angela
    Eliasen, Astrid
    Berthelsen, Kasper K.
    Kuhlman, Anja B.
    Baekdal, Tine A.
    Nejad, Ayna B.
    DIABETES OBESITY & METABOLISM, 2024, 26 (12): : 5805 - 5811