Publications

Harmonisation of Read-Across Methodology for Drug Substance Extractables and Leachables (E&Ls)

Melisa Masuda-Herrera, Hannah T. Rosen, Anders Burild, Thomas Broschard, Tyler Bell, Jessica Graham, Troy Griffin, Jedd Hillegass, Penny Leavitt, Brian Huta, Patricia Parris, Uma Bruen, Maureen Cruz, Joel Bercu

Regulatory Toxicology and Pharmacology
September 2023

Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis

Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T Cruz and Lee Nagao

PDA Journal of Pharmaceutical Science and Technology

September 2023

Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) Relevant to Parenteral Extractables and Leachables (E&Ls)

Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee M. Nagao, Maureen T. Cruz

PDA Journal of Pharmaceutical Science and Technology
January 2022

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

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

Regulatory Toxicology and Pharmacology
26 August 2016