Regulatory science and considerations for drug products containing nanomaterials: FDA perspective

被引：0
|
作者：
Cruz, Celia [1 ]
机构：
[1] US FDA, CDER, Silver Spring, MD USA
来源：
ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY | 2018年 / 256卷
关键词：
D O I：
暂无
中图分类号：
O6 [化学];
学科分类号：
0703 ;
摘要：
18
引用
收藏
页数：1
相关论文
共 50 条
  • [21] Statistical and regulatory considerations in assessments of interchangeability of biological drug products
    Tothfalusi, Laszlo
    Endrenyi, Laszlo
    Chow, Shein-Chung
    EUROPEAN JOURNAL OF HEALTH ECONOMICS, 2014, 15 : S5 - S11
  • [22] Generic drug device combination products: Regulatory and scientific considerations
    Choi, Stephanie H.
    Wang, Yan
    Conti, Denise S.
    Raney, Sam G.
    Delvadia, Renishkumar
    Leboeuf, Andrew A.
    Witzmann, Kimberly
    INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2018, 544 (02) : 443 - 454
  • [23] Practical, regulatory and clinical considerations for development of inhalation drug products
    Hou, Shuguang
    Wu, Jiangyue
    Li, Xu
    Shu, Hong
    ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2015, 10 (06) : 490 - 500
  • [24] FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science
    Fang, Hong
    Harris, Stephen C.
    Liu, Zhichao
    Zhou, Guangxu
    Zhang, Guoping
    Xu, Joshua
    Rosario, Lilliam
    Howard, Paul C.
    Tong, Weida
    DRUG DISCOVERY TODAY, 2016, 21 (10) : 1566 - 1570
  • [25] Science-based regulatory considerations for regenerative medicine cellular products
    Lam, Johnny
    Sung, Kyung E.
    Oh, Steven S.
    CURRENT OPINION IN BIOMEDICAL ENGINEERING, 2022, 21
  • [26] NASH: regulatory considerations for clinical drug development and U.S. FDA approval
    Brian E. Harvey
    Acta Pharmacologica Sinica, 2022, 43 : 1210 - 1214
  • [27] FDA unveils regulatory science plan
    Kondro, Wayne
    CANADIAN MEDICAL ASSOCIATION JOURNAL, 2011, 183 (13) : E1014 - E1015
  • [28] Regulatory Perspective (FDA/EU/Other)
    Breckenridge, A.
    MOVEMENT DISORDERS, 2010, 25 : S609 - S609
  • [29] FDA AND THE BIOEQUIVALENCE OF DRUG PRODUCTS
    SKELLY, JP
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1980, 180 (AUG): : 7 - MEDI
  • [30] Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
    Rodney Rouse
    Naomi Kruhlak
    James Weaver
    Keith Burkhart
    Vikram Patel
    David G. Strauss
    Therapeutic Innovation & Regulatory Science, 2018, 52 : 244 - 255
12345