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Article CommentaryCommentary

Recombinant Factor C Validation—Simpler Than You Think!

Thomas Uhlig, Kevin L. Williams and Brendan Tindall
PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 391-393; DOI: https://doi.org/10.5731/pdajpst.2020.012476
Thomas Uhlig
bioMérieux Deutschland GmbH, Am Neuland 1, 82347 Bernried, Germany
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  • For correspondence: thomas.uhlig@biomerieux.com
Kevin L. Williams
bioMérieux Deutschland GmbH, Am Neuland 1, 82347 Bernried, Germany
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Brendan Tindall
bioMérieux Deutschland GmbH, Am Neuland 1, 82347 Bernried, Germany
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Article Information

vol. 75 no. 4 391-393
DOI 
https://doi.org/10.5731/pdajpst.2020.012476
PubMed 
33608473

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online August 3, 2021.

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  • previous version (February 19, 2021 - 05:13).
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© PDA, Inc. 2021

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PDA Journal of Pharmaceutical Science and Technology: 75 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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Recombinant Factor C Validation—Simpler Than You Think!
Thomas Uhlig, Kevin L. Williams, Brendan Tindall
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 391-393; DOI: 10.5731/pdajpst.2020.012476

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Recombinant Factor C Validation—Simpler Than You Think!
Thomas Uhlig, Kevin L. Williams, Brendan Tindall
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 391-393; DOI: 10.5731/pdajpst.2020.012476
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  • Article
    • What Needs to Be Done for rFC Method Validation?
    • What is Bacterial Endotoxin Testing (BET) Validation?
    • Why Favor an rFC Assay?
    • What About the Authorities?
    • Do We Need to Demonstrate All Eight Aspects?
    • What Does Specificity Mean for BET?
    • Is a Side-by-Side Comparison with LAL Required for Validating an rFC Assay?
    • What Comes Next?
    • Conflict of Interest Declaration
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  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • Expanding the Use of Moist Heat for Terminal Sterilization
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