N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP-Reference-Cited by-同舟云学术

登录注册会员服务联系我们

N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP

Published:2024-09 Issue: Volume:152 Page:105681
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Powley Mark W.,Sobol Zhanna,Johnson George E.,Clark Robert W.,Dalby Stephen M.,Ykoruk Bridget A.,Galijatovic-Idrizbegovic Alema,Mowery Mark D.,Escobar Patricia A.

Funder

Merck

Publisher

Elsevier BV

Reference36 articles.

1. RecoverEase™ DNA isolation Kit, Instruction manual;Agilent Document 720202-12, Revision D0,2018

2. Comparison of the transgenic rodent mutation assay, error corrected next generation duplex sequencing, and the alkaline comet assay to detect dose-related mutations following exposure to N-nitrosodiethylamine;Bercu;Mutat. Res.,2023

3. Acceptable intakes (AIs) for small molecule N-nitrosamines (NAs);Bercu;Regul. Toxicol. Pharmacol.,2023

4. Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 nitrosamine impurities in human medicinal products;EMA/409815/2020 Rev,2024

5. Appendix 1 to Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 nitrosamine impurities in human medicinal products: acceptable intakes established for N-nitrosamines;EMA/307633/2024 Rev,2024

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370

www.globalauthorid.com

TOP