CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

被引：12

作者：

Cruz, Celia N. ^{[1
]}

Tyner, Katherine M. ^{[1
]}

Velazquez, Lydia ^{[1
]}

Hyams, Kenneth C. ^{[1
]}

Jacobs, Abigail ^{[1
]}

Shaw, Arthur B. ^{[1
]}

Jiang, Wenlei ^{[1
]}

Lionberger, Robert ^{[1
]}

Hinderling, Peter ^{[1
]}

Kong, Yoon ^{[1
]}

Brown, Paul C. ^{[1
]}

Ghosh, Tapash ^{[1
]}

Strasinger, Caroline ^{[1
]}

Suarez-Sharp, Sandra ^{[1
]}

Henry, Don ^{[1
]}

Van Uitert, Maat ^{[1
]}

Sadrieh, Nakissa ^{[1
]}

Morefield, Elaine ^{[1
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

AAPS JOURNAL | 2013年 / 15卷 / 03期

关键词：

CDER; nanomaterial; nanotechnology; risk assessment; risk management;

D O I：

10.1208/s12248-013-9466-6

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration was established to assess the possible impact of nanotechnology on drug products. The group is in the process of performing risk assessment and management exercises. The task of the working group is to identify areas where CDER may need to optimize its review practices and to develop standards to ensure review consistency for drug applications that may involve the application of nanotechnology. The working group already performed risk management exercises evaluating the potential risks from administering nanomaterial active pharmaceutical ingredients (API) or nanomaterial excipients by various routes of administration. This publication outlines the risk assessment and management process used by the working group, using nanomaterial API by the oral route of administration as an example.

引用

页码：623 / 628

页数：6

共 50 条

[21] Use of metalloporphyrin catalyst(s) to evaluate biotransformations and potential drug-drug interactions
Chapman, Chiara M.
Jones, Graham B.
Chorghade, Mukund S.
Rahatgaonkar, Anjali M.
Glick, James
ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2014, 247
[22] Potential Risks Associated with the Use of Herbal Anti-Obesity Products
Chan, Thomas Y. K.
DRUG SAFETY, 2009, 32 (06) : 453 - 456
[23] Potential Risks Associated with the Use of Herbal Anti-Obesity Products
Thomas Y. K. Chan
Drug Safety, 2009, 32 : 453 - 456
[24] Use of Internet Search Logs to Evaluate Potential Drug Adverse Events
Sarntivijai, S.
Abernethy, D. R.
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2014, 96 (02) : 149 - 150
[25] The carcinogenic potential of nanomaterials, their release from products and options for regulating them
Becker, Heidi
Herzberg, Frank
Schulte, Agnes
Kolossa-Gehring, Marike
INTERNATIONAL JOURNAL OF HYGIENE AND ENVIRONMENTAL HEALTH, 2011, 214 (03) : 231 - 238
[26] The workplace risk assessment and control (WRAC) process: A tool to evaluate and manage environmental risks
Rostron, CJM
Roopchand, DR
RATIONAL AND SUSTAINABLE DEVELOPMENT OF WATER RESOURCES, VOLS I AND II, 1996, (06): : 691 - 699
[27] Potential exposures and risks from beryllium-containing products
Willis, HH
Florig, HK
RISK ANALYSIS, 2002, 22 (05) : 1019 - 1033
[28] Managing Multiple Risks: Use of a Concise Risk Assessment Format
Firth, Hugh
Spanswick, Mairi
Rutherford, Linda
CHILD AND ADOLESCENT MENTAL HEALTH, 2009, 14 (01) : 48 - 52
[29] Development of an assessment tool to evaluate the risk potential of different gambling types
Meyer, Gerhard
Fiebig, Marisa
Haefeli, Joerg
Moersen, Chantal
INTERNATIONAL GAMBLING STUDIES, 2011, 11 (02) : 221 - 236
[30] Gold Nanomaterials: Preparation, Chemical Modification, Biomedical Applications and Potential Risk Assessment
Jiang, Xiu-Mei
Wang, Li-Ming
Wang, Jing
Chen, Chun-Ying
APPLIED BIOCHEMISTRY AND BIOTECHNOLOGY, 2012, 166 (06) : 1533 - 1551

← 1 2 3 4 5 →