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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 Nagao and Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology January 2022, pdajpst.2021.012693; DOI: https://doi.org/10.5731/pdajpst.2021.012693
Melisa J. Masuda-Herrera
1 Gilead Sciences;
Joel P. Bercu
1 Gilead Sciences;
Thomas H. Broschard
2 Merck KGaA;
Anders Burild
3 Novo Nordisk A/S;
Catrin Hasselgren
4 Genentech, Inc.;
Patricia Parris
5 Pfizer Worldwide Research and Development;
Lucie C. Ford
6 Texas A&M University;
Jessica Graham
4 Genentech, Inc.;
Brad Stanard
7 Ultragenyx Pharmaceutical Inc.;
Michele Comerford
8 Pfizer Global Research & Development;
Daniel Lettiere
8 Pfizer Global Research & Development;
Steffen Erler
9 Wella Company;
Courtney M. Callis
10 Eli Lilly & Company;
Eric Morinello
4 Genentech, Inc.;
Wolfgang Muster
11 Roche Pharmaceutical Research & Early Development;
Elizabeth A. Martin
12 AstraZeneca;
Troy R. Griffin
13 Teva Branded Pharmaceutical Products R&D;
Lee Nagao
14 Faegre Drinker Biddle & Reath LLP
Maureen Cruz
14 Faegre Drinker Biddle & Reath LLP
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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 Nagao, Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology Jan 2022, pdajpst.2021.012693; DOI: 10.5731/pdajpst.2021.012693
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 Nagao, Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology Jan 2022, pdajpst.2021.012693; DOI: 10.5731/pdajpst.2021.012693