ELSIE Consortium

Publications

Publications

Publications

Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Subteam Industry Surveys

Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski

PDA Journal of Pharmaceutical Sciences and Technology
January 2025

Procedural modifications proposed for the screening of substances extracted from pharmaceutical packaging systems and medical devices with the goal of improving inter-laboratory consistency of the data generated

Steven A. Zdravkovic, Samuel Kikandi, Qiang Fu, Bhargava Jana, Jason Creasey, Aaron Flick, Lee Nagao and Mary Kate Bielinski

Journal of Pharmaceutical Sciences
March 2025

Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products

Parris P, Whelan G, Chilton ML, Beaumont C, Burild A, Bruen U, Callis C, Graham J, Kovalova N, Martin EA, Masuda-Herrera M, Worsøe C, Alami A, Bercu J, Doron D, Dusenbury K, Fu Q, Griffin T, Hillegass J, Johann E, Koenig A, Macho N, Martirosyan A, Oded K, Guarch CP, Schmitz M, Stanard B, Tien E, Udovic E, Xu H, Cruz MT, Nagao L

Regul Toxicol Pharmacol.
March 2025

Cell and Gene Therapies: Challenges in Designing Extractables and Leachables Studies and Conducting Safety Assessments

Adeyma Arroyo, Petra Booij, Getachew Woldemariam, Uma Bruen, Jason Creasey, Brad Stanard, Patricia Parris, Lee Nagao, Mary Kate Bielinski 

Journal of Pharmaceutical Sciences
March 2024

 

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