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Article CommentaryCommentary

Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods

Steven Walfish, John Duguid and Karen McCullough
PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 501-511; DOI: https://doi.org/10.5731/pdajpst.2023.012871
Steven Walfish
1Statistical Outsourcing Services, Rockville, MD;
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  • For correspondence: steven@statisticaloutsourcingservices.com
John Duguid
2Research & Development, Vericel Corporation; and
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Karen McCullough
3MMI Associates, LLC
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PDA Journal of Pharmaceutical Science and Technology: 78 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 4
July/August 2024
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Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods
Steven Walfish, John Duguid, Karen McCullough
PDA Journal of Pharmaceutical Science and Technology Jul 2024, 78 (4) 501-511; DOI: 10.5731/pdajpst.2023.012871

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Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods
Steven Walfish, John Duguid, Karen McCullough
PDA Journal of Pharmaceutical Science and Technology Jul 2024, 78 (4) 501-511; DOI: 10.5731/pdajpst.2023.012871
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  • Article
    • Abstract
    • Introduction
    • Other Approaches
    • Experimental Design Considerations for Statistical Equivalence Evaluation
    • A Tale of Two Studies: Product-Specific Equivalence vs Universality and Interchangeability of Test Methods
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