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Qualification of the human PK assay: Statistical analysis of the standard curve responses across the 3 test products
| Product 1 | Product 2 | Ratio of Product 1/Product 2 | Lower Bound of the 90% CI | Upper Bound of the 90% CI |
|---|---|---|---|---|
| Biosimilar | EU-authorized Reference | 1.00 | 0.93 | 1.08 |
| Biosimilar | FDA-licensed Reference | 0.96 | 0.86 | 1.06 |
| EU-authorized Reference | FDA-licensed Reference | 1.14 | 1.03 | 1.26 |
