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New Recommendations For Assessing Extractables Leachables In Parenteral Drug Products

As therapeutics become increasingly complex, so does the challenge of assessing potential risks associated with chemical composition of materials.

Diane paskietProduct quality research instituteExtractables working group initiatives for parenteralExtractables leachables working groupLeachables working groupProduct quality researchNasal drug productsWorking groupBest demonstrated practicesParenteral drug productsOphthalmic drug productExtractables working group initiativesPharmaceutical science

Advancing extractables and leachables testing

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

P-TECH Students Compete In Industry Challenge

P-TECH Students Compete In Industry Challenge
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