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Company A is in the process of filing a CBE-30 Manufacturing Site transfer for a product
Company A is in the process of filing a CBE-30 Manufacturing Site transfer for a product. The laboratory is claiming that they have calculated an F2 value of 32 between the reference product and the test product. Furthermore, the observed dissolution values between the reference product and test product are both >85% in 15 minutes.
- What does F1 and F2 stand for?
- Define Test Product
- How many units/dosage forms should be used for profile comparisons?
- Using the information above, what can be concluded about the performance of the Test Product and Reference Product?
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