Extractable and leachable evaluation is an integral part of safety assessment of container closure system, drug-device combinations, manufacturing equipment and accessories, and medical devices. The analytical methods employed in the analysis should be able to quantify toxicologically significant amount of E&L, which is driven by Analytical Evaluation Threshold (AET). This webinar focuses on the application of toxicological principles in defining AET and designing the E&L study. The E&L study may end up in large number of chemicals which requires to be evaluated to determine whether they pose any risk to patient health. We describe how application of science of toxicological risk assessment can make use of all available information for the identified E&L and negate the need for additional E&L studies, thus speeding up the product development and approval.
Key learnings:
- Application of toxicological principles in defining AET
- Screening of E&L and how to prioritise them for detailed toxicological risk assessment
- Use of default approaches
- Computational toxicology for E&L risk assessment
- Application of read across strategy
