Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review

Author:

Sharma NitishORCID,Brahmankar YashadaORCID,Babar DikshaORCID,Bhogle TejasORCID,Mirase RamdasORCID,Rathod RajeshwariORCID,Shah RaviORCID

Publisher

Springer Science and Business Media LLC

Subject

General Medicine

Reference75 articles.

1. Analysis of extractables and leachables analysis of extractables and leachables. C&EN Media Group: American Chemical Society

2. Armstrong BL, Senyurt AF, Narayan V et al (2013) Stir bar sorptive extraction combined with GC–MS/MS for determination of low level leachable components from implantable medical devices. J Pharm Biomed Anal 74:162–170. https://doi.org/10.1016/j.jpba.2012.10.019

3. Bennett P, Specialist T (2017) Extractables and leachables testing a risk based approach. Readind Scientific Services Ltd (RSSL)

4. Broschard TH, Glowienke S, Bruen US et al (2016) Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics—current challenges and approaches. Regul Toxicol Pharmacol 81:201–211. https://doi.org/10.1016/j.yrtph.2016.08.011

5. Bush L (ed) (2020) Extractables and leachables testing for pharmaceutical packaging, products, and medical devices. In: Current trends in mass spectrometry, 12th edn. Wiley

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