Hello again it’s me Dr Candice Johnson. The E&L conference took place on May 17th – 18th and it was so nice meeting colleagues and hearing about all the developments in the E&L field. The E&L community is eagerly anticipating the changes that the ISO-10993-17 standard and the ICH Q3E guideline will bring. Several presentations …
Continue reading “Extractables and Leachables (E&L) USA 2023 Conference”
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 …
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 …
