Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

被引:17
|
作者
Sanyal, Arun J. [1 ]
Miller, Veronica [2 ]
机构
[1] VCU Sch Med, Dept Med, MCV Box 980341, Richmond, VA 23298 USA
[2] Univ Calif Berkeley, Sch Publ Hlth, Berkeley, CA 94720 USA
关键词
Alcoholic Hepatitis; Nonalcoholic Steatohepatitis; Regulatory Science; Drug Approval; Clinical Trials; End Points; Trial Design; Drug Development; RISK-FACTORS; HEPATITIS; OUTCOMES; CHALLENGES; MELD;
D O I
10.1053/j.gastro.2016.02.044
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
[No abstract available]
引用
收藏
页码:1723 / 1727
页数:5
相关论文
共 50 条
  • [41] Comparison of hepatocellular carcinoma patients with alcoholic liver disease and nonalcoholic steatohepatitis
    Hashimoto, E
    Taniai, M
    Kaneda, H
    Tokushige, K
    Hasegawa, K
    Okuda, H
    Shiratori, K
    Takasaki, K
    ALCOHOLISM-CLINICAL AND EXPERIMENTAL RESEARCH, 2004, 28 (08) : 164S - 168S
  • [42] Alcoholic and non-alcoholic steatohepatitis: global perspective and emerging science
    Brar, Gurmehr
    Tsukamoto, Hidekazu
    JOURNAL OF GASTROENTEROLOGY, 2019, 54 (03) : 218 - 225
  • [43] Alcoholic and non-alcoholic steatohepatitis: global perspective and emerging science
    Gurmehr Brar
    Hidekazu Tsukamoto
    Journal of Gastroenterology, 2019, 54 : 218 - 225
  • [44] Differentiation of nonalcoholic from alcoholic steatohepatitis: are routine laboratory markers useful?
    Kazemi-Shirazi, Lili
    Veloso, Moema Pinheiro
    Frommlet, Florian
    Steindl-Munda, Petra
    Wrba, Fritz
    Zehetmayer, Sonja
    Marsik, Claudia
    Ferenci, Peter
    WIENER KLINISCHE WOCHENSCHRIFT, 2008, 120 (1-2) : 25 - 30
  • [45] Alcoholic, Nonalcoholic, and Toxicant-Associated Steatohepatitis: Mechanistic Similarities and Differences
    Joshi-Barve, Swati
    Kirpich, Irina
    Cave, Matthew C.
    Marsano, Luis S.
    McClain, Craig J.
    CELLULAR AND MOLECULAR GASTROENTEROLOGY AND HEPATOLOGY, 2015, 1 (04): : 356 - 367
  • [46] STATUTORY AND REGULATORY FRAMEWORK FOR DRUG APPROVAL
    BURLINGTON, DB
    JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY, 1990, 3 : S4 - S9
  • [47] Nonalcoholic steatohepatitis - Clinicopathological comparison with alcoholic hepatitis in ambulatory and hospitalized patients
    Pinto, HC
    Baptista, A
    Camilo, ME
    Valente, A
    Saragoca, A
    DeMoura, MC
    DIGESTIVE DISEASES AND SCIENCES, 1996, 41 (01) : 172 - 179
  • [48] Elafibranor: a potential drug for the treatment of nonalcoholic steatohepatitis (NASH)
    Van Meeteren, Menso J. Westerouen
    Drenth, Joost P. H.
    Tjwa, Eric T. T. L.
    EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2020, 29 (02) : 117 - 123
  • [49] Mouse models of nonalcoholic steatohepatitis in preclinical drug development
    Hansen, Henrik H.
    Feigh, Michael
    Veidal, Sanne S.
    Rigbolt, Kristoffer T.
    Vrang, Niels
    Fosgerau, Keld
    DRUG DISCOVERY TODAY, 2017, 22 (11) : 1707 - 1718
  • [50] A COMPARISON OF ALCOHOLIC AND NONALCOHOLIC DRUG-ABUSERS
    WEISS, RD
    MIRIN, SM
    GRIFFIN, ML
    MICHAEL, JL
    JOURNAL OF STUDIES ON ALCOHOL, 1988, 49 (06): : 510 - 515