Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
|Podcasts|March 23, 2021
Challenges with Extractables and Leachables in Medical Devices
Author(s)Waters
Understand challenges posed by updated E&L guidance for medical devices (ISO 10990-18) Insight into considerations for analytical setup that impact regulatory compliance Overview of materials E&L risk profiles and testing requirements
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