Use of surrogate endpoints: A practical necessity in lipid-altering and antiatherosclerosis drug development

被引：0
|
作者：
Orloff, DG [1 ]
机构：
[1] US FDA, Rockville, MD 20857 USA
来源：
AMERICAN JOURNAL OF CARDIOLOGY | 2001年 / 87卷 / 4A期
关键词：
D O I：
暂无
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Apparently favorable effects of antiatherosclerosis drugs as assessed by changes in surrogate markers of cardiovascular disease risk are frequently relied upon for drug approval and labeling. Surrogates must be biologically plausible and adequately validated but are, by definition, imperfect as predictors of ultimate outcome (i.e., serious morbidity and mortality). Surrogate markers utilized in the study of drugs for the treatment of atherosclerotic cardiovascular disease may be classified as laboratory/biochemical, anatomic/morphologic, and functional. The places for various surrogates in all three categories in the development of lipid altering drugs are discussed, (C)2001 by Excerpta Medico, Inc.
引用
收藏
页码：35A / 41A
页数：7
相关论文
共 38 条
  • [21] Use apolipoprotein parameters and endpoints in drug development and approval processes
    Alaupovic, P
    AMERICAN JOURNAL OF CARDIOLOGY, 1998, 81 (8A): : 40F - 47F
  • [22] Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process
    Bujkiewicz, Sylwia
    Thompson, John R.
    Riley, Richard D.
    Abrams, Keith R.
    STATISTICS IN MEDICINE, 2016, 35 (07) : 1063 - 1089
  • [23] Commentary on “Surrogate Endpoints In Aids Drug Development: Current Status”, By Christy Chuang-Stein and Ralph Demasi
    Susan S. Ellenberg
    Drug information journal : DIJ / Drug Information Association, 1998, 32 (2): : 449 - 452
  • [24] Commentary on "Surrogate endpoints in AIDS drug development: Current status," by Christy Chuang-Stein and Ralph DeMasi
    Ellenberg, SS
    DRUG INFORMATION JOURNAL, 1998, 32 (02): : 449 - 452
  • [25] The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development
    Lathia, C. D.
    Amakye, D.
    Dai, W.
    Girman, C.
    Madani, S.
    Mayne, J.
    MacCarthy, P.
    Pertel, P.
    Seman, L.
    Stoch, A.
    Tarantino, P.
    Webster, C.
    Williams, S.
    Wagner, J. A.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 86 (01) : 32 - 43
  • [26] Discussion of “Surrogate Endpoints in Aids Drug Development: Current Status” by C. Chuang-Stein and R. Demasi
    A. Lawrence Gould
    Drug information journal : DIJ / Drug Information Association, 1998, 32 : 453 - 456
  • [27] Discussion of "Surrogate endpoints in AIDS drug development: Current status" by C. Chuang-Stein and R. DeMasi
    Gould, AL
    DRUG INFORMATION JOURNAL, 1998, 32 (02): : 453 - 456
  • [28] Case Study in the Design of a Surrogate Solution for Use in Biopharmaceutical Drug Product Process Development
    Boksa, Kevin
    Walsh, Peter
    Shah, Ambarish
    AAPS PHARMSCITECH, 2021, 22 (01)
  • [29] Case Study in the Design of a Surrogate Solution for Use in Biopharmaceutical Drug Product Process Development
    Kevin Boksa
    Peter Walsh
    Ambarish Shah
    AAPS PharmSciTech, 22
  • [30] Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process (vol 35, pg 1063, 2016)
    Bujkiewicz, Sylwia
    STATISTICS IN MEDICINE, 2022, 41 (30) : 5877 - 5878
1234