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Evaluation of the toxicological screening limit and threshold of toxicological concern in medical device toxicological risk assessment for various patient populations

delete2026-05-05
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PRE
AI
S
Shaoping Wu *
J
Jared Wilsey
M
Matt Lewis
M
Mao-wen Weng
Y
Yayi Swain
J
Joelle Hakimi
J
Junia Pereira
X
Xiaoling (Sharlene) Dai
E
Echoleah S. Rufer
S
Scott Citrowske
R
Robert Shulfer
M
Marika Kamberi
DOI:10.1016/j.yrtph.2026.106120delete
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Abstract

Abstract

En 中文
• TSL and TTC are protective for toxicological risk assessment of medical devices used by adults. • TSL is protective for toxicological risk assessment of medical devices for pediatrics > 6 months. • For TTC, additional considerations in the toxicological risk assessment may be necessary to improve confidence for infants < 6 months. • This analysis confirms that TSL and TTC are adequately protective for individuals older than 6 months of age.
Keywords:
Toxicological Screening Limit
Threshold of Toxicological Concern
Medical Device Risk Assessment
Pediatric Populations
Adult Populations

Journal

Regulatory Toxicology and Pharmacology cover
Regulatory Toxicology and Pharmacology
IF:
3.5
Papers:
4.6K
Citations:
1.0W

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