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 Binazo, Amanda Giddings, Geraldine Whelan, Melisa Masuda-Herrera, Joel Bercu, Thomas Broschard, Uma Bruen, Courtney M Callis, Cheryl L M Stults, Gregory L Erexson, Maureen T Cruz, Lee M Nagao

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Regulatory Toxicology and Pharmacology
December 2020

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – Current challenges and approaches

Thomas H. Broschard, Susanne Glowienke, Uma S. Bruen, Lee M. Nagao, Andrew Teasdale, Cheryl L. M. Stults, Kim L. Li, Laurie A. Iciek,  Greg Erexson, Elizabeth A. Martin, Douglas J. Ball

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Regulatory Toxicology and Pharmacology
26 August 2016

Risk Assessment of Cyclic Siloxanes (D3 to D19) as Extractables from Polymeric Components in Biopharmaceutical Manufacturing

Kim Li, David Dolan, Greg Erexson, and Lee Nagao

SOT 54th Annual Meeting

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Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review

Dennis Jenke, Cheryl Stults, Diane Paskiet, Douglas Ball, and Lee Nagao

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PDA Journal of Pharmaceutical Sciences and Technology
Feb 2015

Evaluation of Extractables in Processed and Unprocessed Polymer Materials Used for Pharmaceutical Applications

Cheryl Stults, Jennifer Ansell, Arthur Shaw, Lee Nagao

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AAPS Pharm SciTech
Feb 2015

Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study

Andrew Teasdale, Michael Jahn, Simon Bailey, Andrew Feilden, Graham Taylor, Marta L. Corcoran, Robert Malick, Dennis Jenke, Cheryl Stults, Lee Nagao

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AAPS Pharm SciTech
16 Dec 2014

The ELSIE Extractables and Leachables Database

Lee Nagao, William Beierschmitt, Douglas Ball, Arthur Shaw, Steve Beck

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Pharmaceutical Outsourcing
Nov 2011