Characteristics of clinical trials to support approval of orphan drugs for neurological disorders by the Japanese regulatory agency

被引:0
|
作者
Nakamura, H. [1 ]
Takeda, S. [2 ]
Iwasaki, M. [3 ]
机构
[1] Natl Ctr Neurol & Psychiat, Translat Med Ctr, Kodaira, Tokyo, Japan
[2] Natl Ctr Neurol & Psychiat, Natl Inst Neurosci, Kodaira, Tokyo, Japan
[3] Univ Yamanashi, Dept Clin Res, Interdisciplinary Grad Sch Med & Engn, Kofu, Yamanashi, Japan
关键词
D O I
10.1016/j.jns.2017.08.2385
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
2354
引用
收藏
页码:847 / 847
页数:1
相关论文
共 50 条
  • [21] Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs
    Vokinger, Kerstin Noelle
    Kesselheim, Aaron S.
    HEALTH POLICY, 2019, 123 (08) : 721 - 727
  • [22] Regulatory Frameworks for Approval of Orphan Drugs: A Comparative Overview Highlighting Need for Global Harmonization and Cohesive Guidelines
    Jyoti Pawar
    Sanjay Sharma
    Namita Hegde
    Current Pharmacology Reports, 11 (1)
  • [23] Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval
    Liu, Ian T. T.
    Kesselheim, Aaron S.
    Cliff, Edward R. Scheffer
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2024, 331 (17): : 1471 - 1479
  • [24] Clinical Development and Regulatory Approval of Acute Heart Failure Drugs in Japan
    Shinagawa, Kaori
    CARDIOVASCULAR DRUGS AND THERAPY, 2015, 29 (02) : 107 - 109
  • [25] Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective obser-vational study
    Gyawali, Bishal
    Rome, Benjamin N.
    Kesselheim, Aaron S.
    BMJ-BRITISH MEDICAL JOURNAL, 2021, 374
  • [26] A clinical pharmacology-regulatory perspective on the approval of drugs for rare diseases
    Bashaw, E. D.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2016, 100 (04) : 327 - 329
  • [27] Remarks on the characteristics of detected signals among spontaneous reporting databases (SRDs) from a US regulatory agency, a Japanese regulatory agency and a Japanese company
    Matsushita, Yasuyuki
    Kuroda, Yasufumi
    Sonehara, Satoshi
    Hamada, Chikuma
    Yoshimura, Isao
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2007, 16 : S197 - S197
  • [28] Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs
    Scott, Pamela E.
    Unger, Ellis F.
    Jenkins, Marjorie R.
    Southworth, Mary Ross
    McDowell, Tzu-Yun
    Geller, Ruth J.
    Elahi, Merina
    Temple, Robert J.
    Woodcock, Janet
    JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2018, 71 (18) : 1960 - 1969
  • [29] Clinical trials with psychopharmacologic drugs - a regulatory point of view
    Broich, K
    PHARMACOPSYCHIATRY, 2005, 38 (05) : 233 - 233
  • [30] Study Characteristics and Risk of Bias of Clinical Trials Supporting FDA Approval of Cardiovascular Drugs, 2006-2020
    Shu, Meijun
    Chen, Siliang
    Li, Jiarui
    JOURNAL OF GENERAL INTERNAL MEDICINE, 2022, 37 (11) : 2888 - 2893