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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components

Robin Wagner, Peter Masatani, Dana Grace, Gianpiero Torraca, Stephanie Moore and David Semin
PDA Journal of Pharmaceutical Science and Technology December 2022, pdajpst.2021.012710; DOI: https://doi.org/10.5731/pdajpst.2021.012710

Article Information

pdajpst.2021.012710
DOI 
https://doi.org/10.5731/pdajpst.2021.012710
PubMed 
36572486
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received October 18, 2021
  • Accepted December 15, 2022
  • Published online December 26, 2022.

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Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Robin Wagner1 (rowagner{at}amgen.com),
  2. Peter Masatani2 (pmastani{at}amgen.com),
  3. Dana Grace2 (dhenrick{at}amgen.com),
  4. Gianpiero Torraca1,3 (gtorraca{at}amgen.com),
  5. Stephanie Moore2 (smoore03{at}amgen.com) and
  6. David Semin2 (dsemin{at}amgen.com)
  1. 1 Amgen, Inc;
  2. 2 Amgen, Inc.
  1. ↵* Corresponding author; email: gtorraca{at}amgen.com

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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana Grace, Gianpiero Torraca, Stephanie Moore, David Semin
PDA Journal of Pharmaceutical Science and Technology Dec 2022, pdajpst.2021.012710; DOI: 10.5731/pdajpst.2021.012710
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