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Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies

Patricia Parris, Elizabeth A. Martin, Brad Stanard, Susanne Glowienke, David G. Dolan, Kim Li, Ornella Binazon, Amanda Giddings, Geraldine Whelan, Melisa Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Uma Bruen, Courtney M. Callis, Cheryl L. M. Stults, Gregory L. Erexson, Maureen T. Cruz, Lee M. Nagao

2020Regulatory Toxicology and Pharmacology21 citationsDOI

Topics & Concepts

Risk analysis (engineering)Biochemical engineeringComputer scienceToxicologyMedicineEngineeringBiologyEffects and risks of endocrine disrupting chemicalsSafe Handling of Antineoplastic DrugsPharmaceutical studies and practices
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies | Litcius