New regulatory framework for cancer drug development

被引：8
|
作者：
Jones, Paul S. [1 ]
Jones, David [2 ]
机构：
[1] Canc Res UK, Drug Dev Off, Strategy & Res Funding, London EC1V 4AD, England
[2] Med & Healthcare Prod Regulatory Agcy, London SW1W 9SZ, England
来源：
DRUG DISCOVERY TODAY | 2012年 / 17卷 / 5-6期
关键词：
D O I：
10.1016/j.drudis.2011.12.015
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Recent changes to non-clinical cancer guidelines offer a golden opportunity to expedite the translation of new anticancer drugs into the clinic. In this review we look at how these guidelines can be implemented and how they can be integrated with non-clinical and clinical study design to produce robust and safe clinical trials.
引用
收藏
页码：227 / 231
页数：5
相关论文
共 50 条
  • [1] Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union
    Pignatti, Francesco
    Ehmann, Falk
    Hemmings, Robert
    Jonsson, Bertil
    Nuebling, Micha
    Papaluca-Amati, Marisa
    Posch, Martin
    Rasi, Guido
    [J]. CLINICAL CANCER RESEARCH, 2014, 20 (06) : 1458 - 1468
  • [2] Regulatory Framework for Drug Development in Rare Diseases
    Korth-Bradley, Joan M.
    [J]. JOURNAL OF CLINICAL PHARMACOLOGY, 2022, 62 : S15 - S26
  • [3] The need for a new framework in drug development
    Saul, Helen
    [J]. EUROPEAN JOURNAL OF CANCER, 2009, 45 (05) : 727 - 727
  • [4] Canadian drug regulatory framework
    Kelly, L.
    Lazzaro, M.
    Petersen, C.
    [J]. CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES, 2007, 34 : S3 - S10
  • [5] Regulatory Considerations on Endpoints in Ovarian Cancer Drug Development
    Balasubramaniam, Sanjeeve
    Kim, Geoffrey S.
    Mckee, Amy E.
    Pazdur, Richard
    [J]. CANCER, 2017, 123 (14) : 2604 - 2608
  • [6] Regulatory Framework for Academic Investigator-Sponsored Investigational New Drug Development of Cell and Gene Therapies in the USA
    Anindya Dasgupta
    Kristen Herzegh
    H. Trent Spencer
    Christopher Doering
    Eric Day
    William P. Swaney
    [J]. Current Stem Cell Reports, 2021, 7 : 129 - 139
  • [7] Regulatory Framework for Academic Investigator-Sponsored Investigational New Drug Development of Cell and Gene Therapies in the USA
    Dasgupta, Anindya
    Herzegh, Kristen
    Spencer, H. Trent
    Doering, Christopher
    Day, Eric
    Swaney, William P.
    [J]. CURRENT STEM CELL REPORTS, 2021, 7 (04) : 129 - 139
  • [8] TRANSNATIONAL REGULATORY INTEGRATION AND DEVELOPMENT: A NEW FRAMEWORK FOR INSTITUTIONAL CHANGE
    Bruszt, Laszlo
    McDermott, Gerald A.
    [J]. RAE-REVISTA DE ADMINISTRACAO DE EMPRESAS, 2016, 56 (04): : 447 - 455
  • [9] The changing world of cancer drug development: the regulatory bodies' perspective
    Gravanis, Iordanis
    Vleminckx, Camille
    Jonsson, Bertil
    Pignatti, Francesco
    [J]. CHINESE CLINICAL ONCOLOGY, 2014, 3 (02)
  • [10] Unintended Consequences of Regulatory Initiatives in Childhood Cancer Drug Development
    Adamson, Peter C.
    [J]. JAMA PEDIATRICS, 2013, 167 (10) : 886 - 887
12345