Considerations in the development and control of biosimilar manufacturing in the United States

被引:0
|
作者
Baker, Jeffrey [1 ]
机构
[1] US FDA, Off Biotechnol Prod, CDER, Silver Spring, MD USA
关键词
D O I
暂无
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
191
引用
收藏
页数:1
相关论文
共 50 条
  • [31] Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States
    Dougherty, Michele K.
    Zineh, Issam
    Christl, Leah
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2018, 103 (01) : 36 - 39
  • [32] Dynamics of biological markets with multiple biosimilar competitors in the United States
    Mouslim, Morgane C.
    Socal, Mariana P.
    Trujillo, Antonio J.
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2024, 24 (11) : 1271 - 1278
  • [33] Investigation of Immunogenicity Assessment of Biosimilar Monoclonal Antibodies in the United States
    Cheng, Ching-An
    Jiang, Ai-Lei
    Liu, Yu-Ru
    Chang, Lin-Chau
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 114 (06) : 1274 - 1284
  • [34] AIR POLLUTION CONTROL ON UNITED STATES-MEXICO BORDER - INTERNATIONAL CONSIDERATIONS
    DAVILA, GH
    NATURAL RESOURCES JOURNAL, 1972, 12 (04) : 544 - 550
  • [35] LEGAL AND PSYCHOLOGICAL CONSIDERATIONS IN THE DEVELOPMENT OF A EUTHANASIA STATUTE FOR ADULTS IN THE UNITED-STATES
    MAIER, DM
    NEWMAN, MJ
    BEHAVIORAL SCIENCES & THE LAW, 1995, 13 (01) : 3 - 25
  • [36] CLIMATE CHANGE CONSIDERATIONS IN SUSTAINABLE DEVELOPMENT OF NUCLEAR POWER PLANTS IN THE UNITED STATES
    Wan, Ping K.
    Carson, Alice C.
    Chan, Desmond W.
    PROCEEDINGS OF THE 18TH INTERNATIONAL CONFERENCE ON NUCLEAR ENGINEERING 2010, VOL 6, 2011, : 403 - 407
  • [37] Regulatory Considerations for Hemodiafiltration in the United States
    Ward, Richard A.
    Vienken, Joerg
    Silverstein, Douglas M.
    Ash, Stephen
    Canaud, Bernard
    CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2018, 13 (09): : 1444 - 1449
  • [38] Homelessness in the United States: Policy considerations
    Toro, PA
    Warren, MG
    JOURNAL OF COMMUNITY PSYCHOLOGY, 1999, 27 (02) : 119 - 136
  • [39] Biosimilar Manufacturing Challenges
    Genet. Eng. Biotechnol. News, 19 (30-31):
  • [40] Development of Pacific whiting fish sauce: Market potential and manufacturing in the United States
    Tungkawachara, S
    Park, JW
    ADVANCES IN SEAFOOD BYPRODUCTS, 2002 CONFERENCE PROCEEDINGS, 2003, : 321 - 331