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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;
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  • For correspondence: melisa.masuda-herrera@gilead.com
Joel P. Bercu
1 Gilead Sciences;
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  • For correspondence: joel.bercu@gilead.com
Thomas H. Broschard
2 Merck KGaA;
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  • For correspondence: thomas.broschard@merckgroup.com
Anders Burild
3 Novo Nordisk A/S;
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  • For correspondence: qabu@novonordisk.com
Catrin Hasselgren
4 Genentech, Inc.;
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  • For correspondence: hasselgren.catrin@gene.com
Patricia Parris
5 Pfizer Worldwide Research and Development;
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  • For correspondence: patricia.parris@pfizer.com
Lucie C. Ford
6 Texas A&M University;
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  • For correspondence: lucie.ford@tamu.edu
Jessica Graham
4 Genentech, Inc.;
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  • For correspondence: graham.jessica@gene.com
Brad Stanard
7 Ultragenyx Pharmaceutical Inc.;
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  • For correspondence: bstanard@ultragenyx.com
Michele Comerford
8 Pfizer Global Research & Development;
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  • For correspondence: michele.comerford@pfizer.com
Daniel Lettiere
8 Pfizer Global Research & Development;
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  • For correspondence: daniel.j.lettiere@pfizer.com
Steffen Erler
9 Wella Company;
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  • For correspondence: steffen.erler@wella.com
Courtney M. Callis
10 Eli Lilly & Company;
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  • For correspondence: courtney.callis@lilly.com
Eric Morinello
4 Genentech, Inc.;
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  • For correspondence: morinello.eric@gene.com
Wolfgang Muster
11 Roche Pharmaceutical Research & Early Development;
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  • For correspondence: wolfgang.muster@roche.com
Elizabeth A. Martin
12 AstraZeneca;
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  • For correspondence: elizabeth.martin@astrazeneca.com
Troy R. Griffin
13 Teva Branded Pharmaceutical Products R&D;
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  • For correspondence: troy.griffin@tevapharm.com
Lee Nagao
14 Faegre Drinker Biddle & Reath LLP
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  • For correspondence: lee.nagao@faegredrinker.com
Maureen Cruz
14 Faegre Drinker Biddle & Reath LLP
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  • For correspondence: maureen.cruz@faegredrinker.com
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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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, Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology Jan 2022, pdajpst.2021.012693; DOI: 10.5731/pdajpst.2021.012693

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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, Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology Jan 2022, pdajpst.2021.012693; DOI: 10.5731/pdajpst.2021.012693
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Cited By...

  • Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
  • Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments
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More in this TOC Section

  • A proof-of-concept study on a universal standard kit to evaluate the risks of inspectors for their foundational ability of visual inspection of injectable drug products
  • Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
  • Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Show more Research

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Keywords

  • ELSIE
  • Extractables
  • Leachables
  • Parenteral
  • Point of departure
  • Threshold of toxicological concern

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