Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control
Andrew Teasdale
1
,
David Elder
2
,
Sou-Jen Chang
3
,
Sophie Wang
4
,
Richard Thompson
5
,
Nancy Benz
6
,
Ignacio H Sanchez Flores
7
1
3
Abbott Laboratories, 200 Abbott Park Road, PA71, Building AP-50, Abbott Park, Illinois
60064-6220, United States
|
4
Amgen Inc., 1 Amgen Center Drive, Thousand
Oaks, California 91320, United States
|
5
Ben Venue Laboratories Inc., Boehringer Ingelheim, 300 Northfield Road, Bedford,
Ohio 44146, United States
|
6
Abbott Laboratories Department R45T, Building
R8-2, 1401 Sheridan Road, North Chicago, Illinois 60064, United States
|
7
Takeda Global Research & Development Center, Inc., One Takeda Parkway, Deerfield, Illinois 60015, United States
|
Publication type: Journal Article
Publication date: 2013-02-04
scimago Q1
wos Q1
SJR: 0.865
CiteScore: 5.4
Impact factor: 3.5
ISSN: 10836160, 1520586X
Organic Chemistry
Physical and Theoretical Chemistry
Abstract
The control of genotoxic impurities (GTIs) is a crucial activity that is performed for any new chemical entity intended for clinical use. A key element of this is the quality risk assessment. This article seeks to examine the primary components of such a strategy, focusing specifically on the effective use of in silico assessment tools to augment this process, in particular the calculation of theoretical purge factors based on the physicochemical properties of a specific GTI and its interrelationship to the process.
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112
Total citations:
112
Citations from 2024:
19
(16.96%)
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MLA
Cite this
GOST
Copy
Teasdale A. et al. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control // Organic Process Research and Development. 2013. Vol. 17. No. 2. pp. 221-230.
GOST all authors (up to 50)
Copy
Teasdale A., Elder D., Chang S., Wang S., Thompson R., Benz N., Sanchez Flores I. H. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control // Organic Process Research and Development. 2013. Vol. 17. No. 2. pp. 221-230.
Cite this
RIS
Copy
TY - JOUR
DO - 10.1021/op300268u
UR - https://doi.org/10.1021/op300268u
TI - Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control
T2 - Organic Process Research and Development
AU - Teasdale, Andrew
AU - Elder, David
AU - Chang, Sou-Jen
AU - Wang, Sophie
AU - Thompson, Richard
AU - Benz, Nancy
AU - Sanchez Flores, Ignacio H
PY - 2013
DA - 2013/02/04
PB - American Chemical Society (ACS)
SP - 221-230
IS - 2
VL - 17
SN - 1083-6160
SN - 1520-586X
ER -
Cite this
BibTex (up to 50 authors)
Copy
@article{2013_Teasdale,
author = {Andrew Teasdale and David Elder and Sou-Jen Chang and Sophie Wang and Richard Thompson and Nancy Benz and Ignacio H Sanchez Flores},
title = {Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control},
journal = {Organic Process Research and Development},
year = {2013},
volume = {17},
publisher = {American Chemical Society (ACS)},
month = {feb},
url = {https://doi.org/10.1021/op300268u},
number = {2},
pages = {221--230},
doi = {10.1021/op300268u}
}
Cite this
MLA
Copy
Teasdale, Andrew, et al. “Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control.” Organic Process Research and Development, vol. 17, no. 2, Feb. 2013, pp. 221-230. https://doi.org/10.1021/op300268u.