The FDA released a relatively short draft guidance "Considerations in Demonstrating Interchangeability With a Reference Product: Update". With only 2 sections and 4 pages within the body, it covers "considerations regarding a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product." With only the Introduction and Discussion – it provides a succinct guide to the work needed to demonstrate interchangeability and is replete with references to publications and other governing law and regulations.
#fda #interchangability #DraftGuidance #switchingstudies
https://www.fda.gov/media/179456/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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