Document Detail


CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products.
MedLine Citation:
PMID:  23512727     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Celia N Cruz; Katherine M Tyner; Lydia Velazquez; Kenneth C Hyams; Abigail Jacobs; Arthur B Shaw; Wenlei Jiang; Robert Lionberger; Peter Hinderling; Yoon Kong; Paul C Brown; Tapash Ghosh; Caroline Strasinger; Sandra Suarez-Sharp; Don Henry; Maat Van Uitert; Nakissa Sadrieh; Elaine Morefield
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Publication Detail:
Type:  Journal Article     Date:  2013-03-20
Journal Detail:
Title:  The AAPS journal     Volume:  15     ISSN:  1550-7416     ISO Abbreviation:  AAPS J     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-26     Completed Date:  2014-01-22     Revised Date:  2014-03-25    
Medline Journal Info:
Nlm Unique ID:  101223209     Medline TA:  AAPS J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  623-8     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Drug Approval / methods*
Drug Evaluation / methods,  standards
Humans
Nanostructures / adverse effects,  standards*
Pharmaceutical Preparations / standards*
Risk Assessment / methods,  standards
United States
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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