Extractables and Leacheables in Drug Development
Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology. Dr. Persiani in his current role applies translational approaches from drug discovery to development and registration in several therapeutic areas. Dr. Persiani is a member of various international scientific societies and serves on the review board of numerous professional journals. Dr. Persiani acts as an external expert evaluator for the European Commission on the 7th Framework Program, Maria Sklodowska-Curie Individual Fellowships, HORIZON 2020, and Innovative Medicine Initiative. Dr. Persiani is also an expert evaluator for La Caixa Foundation where he evaluates and provides recommendations to the bank on applications requesting funding. Dr. Persiani is a faculty of Pharmaceutical Training International and Traininng.com where he provides training to pharmaceutical executives in several fields of Translational Sciences.
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.
- 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
Course Level - Basic
Who Should Attend
- Project managers
- Regulatory affairs
- Pharmaceutical development scientist
- Drug discovery scientists
- CMC scientists
- Clinical development scientists
Why Should You Attend
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.