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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.

United statesDiane paskietHannah balfourProduct quality research instituteInternational council for harmonisationDrug administrationInternational councilOphthalmic drug productsEuropean pharmaceutical reviewWest pharmaceuticalConcern thresholdEvaluation thresholdPharmaceutical scienceAnalytical evaluation thresholdTechnical requirementsHuman use