Impurities in New Drug Substances and New Drug Products-Reference-Cited by-同舟云学术

登录注册会员服务联系我们

Impurities in New Drug Substances and New Drug Products

Published:2017-09-29 Issue: Volume: Page:167-198
ISSN:
Container-title:ICH Quality Guidelines
language:
Short-container-title:

Author:

Teasdale Andrew¹,Elder David²,Harvey James³,Spanhaak Steven⁴

Affiliation:

1. AstraZeneca; Macclesfield UK

2. David P Elder Consultancy; Hertford UK

3. GSK; Ware UK

4. Janssen Pharmaceutica NV; Beerse Belgium

Publisher

John Wiley & Sons, Inc.

Reference42 articles.

1. ICH Q3A(R2) 2006 Impurities in new drug substances

2. ICH Q3B(R2) 2006 Impurities in new drug products

3. ICH Q3C(5) 2011 Impurities: Guidelines for residual solvents

4. ICH Q3D 2014 Guideline for elemental impurities

5. ICH M7 2014 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Cited by 12 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Forced Degradation Products of Olmesartan Medoxomil and their In Vitro Genotoxicity Assessment by Comet Assay using HEK Cells;ChemistrySelect;2024-04-25

2. Stability Indicating RP-HPLC Method for the Estimation of Impurities in Esomeprazole Gastro-Resistant Tablets by AQbD Approach;BIO Integration;2024

3. Combining Different Stationary-Phase Chemistries to Improve the Selectivity of Impurity Profiling Methods;LCGC North America;2023-04-01

4. A Review on Force Degradation Studies for Drug Substances;International Journal of Advanced Research in Science, Communication and Technology;2023-02-25

5. Mathematical Modeling and Optimization to Inform Impurity Control in an Industrial Active Pharmaceutical Ingredient Manufacturing Process;Organic Process Research & Development;2022-09-21

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

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号京ICP备18003416号-3