Analysis of Typical Problems of Moderate Change in Post-approval Chemical Drugs

被引：0
|
作者：
Yuan, Jianlong [1 ]
Zhang, Lingna [1 ]
Chen, Qingyu [1 ]
Huang, Rongzhen [1 ]
机构：
[1] Fujian Center for Drug Evaluation and Monitoring, Fuzhou,350003, China
来源：
Chinese Journal of Pharmaceuticals | 2023年 / 54卷 / 10期
关键词：
D O I：
10.16522/j.cnki.cjph.2023.10.017
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：1517 / 1520
相关论文
共 50 条
  • [1] Explaination of New Guideline for Post-approval Changes to Chemical Drug in Combination with the Post-approval Change Managements in China, the United States and Europe
    Zhang, Baomei
    Lu, Xiaojun
    Chinese Journal of Pharmaceuticals, 2022, 53 (07) : 1056 - 1061
  • [2] More Predictable Post-Approval Change Policy on Horizon
    Wechsler, Jill
    BIOPHARM INTERNATIONAL, 2019, 32 (09) : 8 - 10
  • [3] More predictable post-approval change policy on Horizon
    Wechsler, Jill
    Pharmaceutical Technology, 2019, 43 (09) : 14 - 15
  • [4] Post-approval Studies for Rare Disease Treatments and Orphan Drugs
    Maier, William C.
    Christensen, Ronald A.
    Anderson, Patricia
    RARE DISEASES EPIDEMIOLOGY: UPDATE AND OVERVIEW, 2ND EDITION, 2017, 1031 : 197 - 205
  • [5] Post-Approval Safety Issues with Innovative Drugs: A European Cohort Study
    Peter G. M. Mol
    Arna H. Arnardottir
    Domenico Motola
    Patrick J. Vrijlandt
    Ruben G. Duijnhoven
    Flora M. Haaijer-Ruskamp
    Pieter A. de Graeff
    Petra Denig
    Sabine M. J. M. Straus
    Drug Safety, 2013, 36 : 1105 - 1115
  • [6] Post-Approval Safety Issues with Innovative Drugs: A European Cohort Study
    Mol, Peter G. M.
    Arnardottir, Arna H.
    Motola, Domenico
    Vrijlandt, Patrick J.
    Duijnhoven, Ruben G.
    Haaijer-Ruskamp, Flora M.
    de Graeff, Pieter A.
    Denig, Petra
    Straus, Sabine M. J. M.
    DRUG SAFETY, 2013, 36 (11) : 1105 - 1115
  • [7] A Global Industry Survey on Post-Approval Change Management and Use of Reliance
    Deavin, Andrew
    Hossain, Aliyah
    Colmagne-Poulard, Isabelle
    Wong, Kum Cheun
    Perea-Velez, Monica
    Cappellini, Sonia
    Ausborn, Susanne
    Meillerais, Sylvie
    Bourguignon, Celine
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2024, 58 (06) : 1094 - 1107
  • [8] Post-approval Change Submission: ICH Q12 Impact Analysis on India and Japan
    Moorkoth, S.
    Haldar, T.
    INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2020, 82 (01) : 2 - 10
  • [9] Do post-approval phase III trials for accelerated approved cancer drugs violate equipoise?
    Lurie, A. J.
    Djulbegovic, B.
    Nebeker, J. R.
    Angelotta, C.
    Gordon, L. I.
    Raisch, D. W.
    Yarnold, P. R.
    Carson, K. R.
    McKoy, J. M.
    Bennett, C. L.
    JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (18) : 307S - 307S
  • [10] Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database
    Mott, Katrina
    Graham, David J.
    Toh, Sengwee
    Gagne, Joshua J.
    Levenson, Mark
    Ma, Yong
    Reichman, Marsha E.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2016, 25 (09) : 1023 - 1032
12345