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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

Article Information

pdajpst.2021.012693
DOI 
https://doi.org/10.5731/pdajpst.2021.012693
PubMed 
35031541
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received September 24, 2021
  • Accepted January 10, 2022
  • Published online January 14, 2022.

Article Versions

Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Melisa J. Masuda-Herrera1,15 (melisa.masuda-herrera{at}gilead.com),
  2. Joel P. Bercu1 (joel.bercu{at}gilead.com),
  3. Thomas H. Broschard2 (thomas.broschard{at}merckgroup.com),
  4. Anders Burild3 (qabu{at}novonordisk.com),
  5. Catrin Hasselgren4 (hasselgren.catrin{at}gene.com),
  6. Patricia Parris5 (patricia.parris{at}pfizer.com),
  7. Lucie C. Ford6 (lucie.ford{at}tamu.edu),
  8. Jessica Graham4 (graham.jessica{at}gene.com),
  9. Brad Stanard7 (bstanard{at}ultragenyx.com),
  10. Michele Comerford8 (michele.comerford{at}pfizer.com),
  11. Daniel Lettiere8 (daniel.j.lettiere{at}pfizer.com),
  12. Steffen Erler9 (steffen.erler{at}wella.com),
  13. Courtney M. Callis10 (courtney.callis{at}lilly.com),
  14. Eric Morinello4 (morinello.eric{at}gene.com),
  15. Wolfgang Muster11 (wolfgang.muster{at}roche.com),
  16. Elizabeth A. Martin12 (elizabeth.martin{at}astrazeneca.com),
  17. Troy R. Griffin13 (troy.griffin{at}tevapharm.com),
  18. Lee Nagao14 (lee.nagao{at}faegredrinker.com) and
  19. Maureen Cruz14 (maureen.cruz{at}faegredrinker.com)
  1. 1 Gilead Sciences;
  2. 2 Merck KGaA;
  3. 3 Novo Nordisk A/S;
  4. 4 Genentech, Inc.;
  5. 5 Pfizer Worldwide Research and Development;
  6. 6 Texas A&M University;
  7. 7 Ultragenyx Pharmaceutical Inc.;
  8. 8 Pfizer Global Research & Development;
  9. 9 Wella Company;
  10. 10 Eli Lilly & Company;
  11. 11 Roche Pharmaceutical Research & Early Development;
  12. 12 AstraZeneca;
  13. 13 Teva Branded Pharmaceutical Products R&D;
  14. 14 Faegre Drinker Biddle & Reath LLP
  1. ↵* Corresponding author; email: melisa.masuda-herrera{at}gilead.com

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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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