Assessing the Safety of Extractables and Leachables for Drug Products: When and How?

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.

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Extractsbles and leashables