Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals

被引：0
|
作者：
Andreas Schick
Kathleen L. Miller
Michael Lanthier
Gerald Dal Pan
Clark Nardinelli
机构：
[1] U.S. Food and Drug Administration,Office of Program and Strategic Analysis, Center for Drug Evaluation and Research
[2] U.S. Food and Drug Administration,Office of Planning, Office of the Commissioner
[3] U.S. Food and Drug Administration,Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research
来源：
Drug Safety | 2017年 / 40卷
关键词：
Boxed Warning; Safety Action; Priority Review; Goal Date; Restricted Indication;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：497 / 503
页数：6
相关论文
共 50 条
  • [1] Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals
    Schick, Andreas
    Miller, Kathleen L.
    Lanthier, Michael
    Dal Pan, Gerald
    Nardinelli, Clark
    DRUG SAFETY, 2017, 40 (06) : 497 - 503
  • [2] A pre-marketing ALT signal predicts post-marketing liver safety
    Moylan, Cynthia A.
    Suzuki, Ayako
    Papay, Julie I.
    Yuen, Nancy A.
    Ames, Michael
    Hunt, Christine M.
    REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2012, 63 (03) : 433 - 439
  • [3] Toxicity spectrum of taxanes: a safety analysis from pre-marketing to post-marketing
    Zhao, Qiuling
    Nian, Zilin
    He, Yimin
    Lai, Lijun
    Liu, Wenbin
    Huang, Shengqiang
    Yang, Lin
    EXPERT OPINION ON DRUG SAFETY, 2025,
  • [4] Post-Marketing Drug Withdrawals: A Review
    Rao, Nutan
    Powar, Roshani
    PHARMACEUTICAL CHEMISTRY JOURNAL, 2023, 57 (07) : 1138 - 1146
  • [5] Post-Marketing Drug Withdrawals: A Review
    Nutan Rao
    Roshani Powar
    Pharmaceutical Chemistry Journal, 2023, 57 : 1138 - 1146
  • [6] Characteristics of post-marketing studies and their contribution to post-marketing safety measures in Japan
    Kanmuri K.
    Narukawa M.
    Pharmaceutical Medicine, 2014, 28 (2) : 67 - 73
  • [7] CLINICAL DATA GAP BETWEEN PHASE III CLINICAL TRIALS (PRE-MARKETING) AND PHASE IV (POST-MARKETING) STUDIES: EVALUATION OF ETANERCEPT IN RHEUMATOID ARTHRITIS
    Farahani, Pendar
    Levine, Mitchell
    Gaebel, Kathryn
    Thabane, Lehana
    JOURNAL OF POPULATION THERAPEUTICS AND CLINICAL PHARMACOLOGY, 2005, 12 (03): : E254 - E263
  • [8] The Practice of Pre-Marketing Safety Assessment in Drug Development
    Chuang-Stein, Christy
    Xia, H. Amy
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2013, 23 (01) : 3 - 25
  • [9] Post-marketing evaluation of the short term safety of COMVAX®
    Davis, RL
    Black, S
    Shinefield, H
    Mahoney, L
    Zavitkovsky, A
    Lewis, E
    Nikas, A
    Guess, H
    Coplan, P
    VACCINE, 2004, 22 (3-4) : 536 - 543
  • [10] Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems
    Aronson, Jeffery K.
    THERAPIE, 2017, 72 (05): : 555 - 561
12345