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PQRI L&E Workshop - DJ Ball. 9. Container Closure Guidance. Safety Characterization of Extractables for Various Routes/Dosage Forms. Route / Dosage Form. 20 Nov 2013 The PDA Journal revisited the topic Leachables and Extractables Testing in The overall positive acceptance of the PQRI recommendations is Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products by Daniel L. 17 Aug 2017 ICH safety-based guidance4,5,6,7,8 does not cover extractables and Research Institute (PQRI) derived 'safety'-based guidance for orally 22 Mar 2017 Extractable and Leachables. PQRI-PODP Working Group Recommendations: Parental Drug Products (PDP). Ophthalmic Drug Products (ODP). 18 Aug 2018 Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations. Key Issues for Clarification and Agency Dialogue: What are appropriate reporting/identification/qualification thresholds for leachables & extractables? How is a 1 Jun 2007 The PQRI Leachables and Extractables Working Group, consisting of In 2006, the PQRI recommendations were submitted to the FDA forThe Product Quality Research Institute (PQRI) Leachables and Extractables and widely-accepted recommendations for leachables assessments to help