Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by pharmaceuticals and biologics manufacturers.
These approaches may differ depending on the nature of the final drug product, the formulation, the route of administration and the length of use. Available regulatory guidelines provide compound-specific indications but do not provide a general and comprehensive approach to safety evaluations of leachable and/or extractable. This webinar provides a general overview of this topic and the possible approaches to safety evaluations of extractable and leachable.
An effective extractable and leachable evaluation is essential for the overall success of any pharmaceutical drug development program for both small molecules and biologicals agents. In this webinar expert speaker, Stefano Persiani will focus on the basics of an effective extractable and leachable program. A case study will be presented to further provide a focus on the concepts discussed.
Areas Covered in the Session :
- Understanding the different types of extractable and leachable
- Recognize the importance of extractable and leachable evaluations
- Learn the necessary steps of extractable and leachable evaluations
- Learn how to deal with extractables and leachables associated with potential safety concerns
- Learn the concept of Permitted Daily Allowance
- Recognize the difference between extractable and leachable assessment when the active ingredient is a small molecule or a biological product
- Influence and motivate cross-functional colleagues to embrace their critical roles in successful extractable and leachable evaluation programs
Who Should Attend:
- Project managers
- Regulatory affairs
- Pharmaceutical development scientist
- Drug discovery scientists
- CMC scientists
- Clinical development scientists