We are delighted to be participating in an upcoming webinar organized by the Extractables and Leachables Safety Information Exchange (ELSIE) Consortium on the topic of a framework for sensitization assessment for Extractables and Leachables (E&L) on 22 September 2022, 9:30 – 11:00 AM ET1. We will be describing the development of a representative database of …
Tag archives: Extractables and leachables
The Leadscope bacterial mutagenicity expert alerts journey to universal regulatory acceptance
It has taken over 10 years, but now Leadscope’s expert rule-based methodology is used every day to support submissions to regulatory agencies around the world, including pharmaceutical impurity assessments aligned with the ICH M7 guideline1, assessment of extractable and leachables, along with other applications. The following blog reviews this journey. The first step in this …