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
  • [1] Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials
    Zheng, Nan
    Sun, Dajun D.
    Zou, Peng
    Jiang, Wenlei
    AAPS JOURNAL, 2017, 19 (03): : 619 - 631
  • [2] Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials
    Nan Zheng
    Dajun D. Sun
    Peng Zou
    Wenlei Jiang
    The AAPS Journal, 2017, 19 : 619 - 631
  • [3] Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials
    Henry A. Havel
    The AAPS Journal, 2016, 18 : 1351 - 1353
  • [4] Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials
    Havel, Henry A.
    AAPS JOURNAL, 2016, 18 (06): : 1351 - 1353
  • [5] FDA regulatory considerations for oncology drug development
    Moon, Hanlim
    Zang, Dae Young
    Ryu, Min-Hee
    Seo, Yeonsook
    Oh, Bitna
    Hwang, Sunjin
    Farrand, Lee
    PHARMACOLOGY RESEARCH & PERSPECTIVES, 2024, 12 (04):
  • [6] Innovation in wound care products: a FDA regulatory perspective
    Chang, Cynthia J.
    Kazemzadeh-Narbat, Mehdi
    JOURNAL OF WOUND CARE, 2021, 30 : S3 - S4
  • [7] A REGULATORY PERSPECTIVE "TRANSPORTERS IN DRUG DEVELOPMENT: SCIENTIFIC AND REGULATORY CONSIDERATIONS"
    Zhang, Lei K.
    DRUG METABOLISM AND PHARMACOKINETICS, 2020, 35 (01) : S2 - S2
  • [8] ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products
    O'Neill, Tyler
    Miksad, Rebecca
    Miller, Danelle
    Maloney, Lesley
    John, Ani
    Hiller, Carolyn
    Hornberger, John
    VALUE IN HEALTH, 2019, 22 (07) : 754 - 761
  • [9] Early Development Challenges for Drug Products Containing Nanomaterials
    Jennifer H. Grossman
    Rachael M. Crist
    Jeffrey D. Clogston
    The AAPS Journal, 2017, 19 : 92 - 102
  • [10] Perspectives on quality attributes of drug products containing nanomaterials
    Hammond, John
    Kleintop, Brent
    Lewen, Nancy
    Zaidi, Kahkashan
    Hickey, Anthony
    Akala, Emmanuel
    Block, Lawrence
    Hussain, Munir
    Liang, June
    Mitchell, Jolyon
    Maurer, Norbert
    Scoggins, Myke
    Shelbourn, Timothy
    Tyner, Katherine
    Welfare, Eloise
    Tice, Thomas
    Pharmaceutical Technology, 2019, 2019 : 12 - 15
12345