Assessing the safety of extractables and leachables for drug products: when and how?
**Wednesday, November 17, 2021 at 11am EST, 10am CST, 8am PST*** TE&L examples are presented for which the critical toxicological endpoints are discussed and evaluated by means of various methods, in terms of deriving appropriate safety limits. *** On demand available after final airing until November 17, 2022.***
Register free: https://www.pharmtech.com/pt_w/safety
Event Overview:
In this webinar, the challenges in toxicological safety assessments for parenteral packaging system applications will be addressed.
Typical toxicological challenges for extractables and leachables are presented, such as difficulties in daily exposure evaluations for a selection of compounds to be evaluated, based on an appropriate selected threshold. Subsequently, typical burden in hazard and risk evaluation relate to data-poor substances often related to rubber closure systems. Within this context, E&L examples are selected for which the critical toxicological endpoints are discussed and evaluated by means of various methods, in terms of deriving appropriate safety limits.
Key Learning Objectives:
- Selecting the right Threshold for E&L screening methodologies
- What will be reasonably exposed to the patient
- Understanding the toxicological safety hurdles and how to overcome them
- Will pro’s and con’s of surrogates be addressed for ADME And DMPK?
Who Should Attend:
- Analytical scientists, safety assessors, regulatory affairs
Speakers:
Kevin Breesch, MSc
Manager Toxicology
Nelson Labs
Time and Date:
Wednesday, November 17, 2021 at 11am EST, 10am CST, 8am PST
On demand available after final airing until November 17, 2022.
Sponsor: Nelson Labs
Register free: https://www.pharmtech.com/pt_w/safety
