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Assessing the Safety of Extractables & Leachables for Drug Products

Published Date: November 22, 2021

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.

Kevin Breesch

Partnership & Toxicology Manager

Kevin Breesch holds a Master in Science, Biochemical Engineering from the University of Leuven, Belgium. He started his career as a lecturer in Total Quality Management. In 2004, Kevin Breesch took the position of QA/QC Manager at Toxikon Europe, now Nelson Labs. After implementing the ISO, GMP and GLP quality systems, he became responsible for the pre-clinical testing services. Currently Kevin is responsible for managing the toxicological safety assessments related to E&L at Nelson Labs.

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