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
Kevin L. Williams
bioMérieux Deutschland GmbH, Am Neuland 1, 82347 Bernried, Germany
Brendan Tindall
bioMérieux Deutschland GmbH, Am Neuland 1, 82347 Bernried, Germany

References
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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
Jump to section
- 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
- References
- Figures & Data
- References
- Info & Metrics
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