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Advancing extractables and leachables testing

Published: April 29, 2022

With comment from Diane Paskiet, chair of the PQRI L&E Working Group, EPR outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.

Source: europeanpharmaceuticalreview.com

Related Topics:

United StatesDiane PaskietHannah BalfourProduct Quality Research InstituteInternational Council For HarmonisationDrug AdministrationInternational CouncilOphthalmic Drug ProductsEuropean Pharmaceutical ReviewWest PharmaceuticalConcern ThresholdEvaluation ThresholdPharmaceutical ScienceAnalytical Evaluation ThresholdTechnical RequirementsHuman UseBest Demonstrated PracticesParenteral Drug ProductsFive MaterialsConstruction RepresentativePackaging Systems UsedOphthalmic DrugModel Container Closure System Applicable