In this webinar Kevin Breesch of Nelson Labs will speak about the challenges of toxicological-safety assessments for parenteral packaging systems.
Typical toxicological challenges for extractables and leachables (E&L) 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:
- To know how to select the right threshold for E&L screening methodologies.
- To know how to determine a reasonable exposure of compounds to the patient.
- To understand the toxicological-safety hurdles and how to overcome them.
