Important Notes while determining dissolution similarity factor using this Model Independent Approach:

• Enter dissolution mean value of 12 units each (reference product/pre-changed product and test product/post-change product).
• The dissolution measurements of the test and reference batches should be made under exactly the same conditions.
• The dissolution time points for both the profiles should be the same (e.g., 15, 30, 45, 60 minutes).
• Only one measurement should be considered after 85% dissolution of both the products.
• To allow use of mean data, the percent coefficient of variation (%RSD) at the earlier time points (e.g., 15 minutes) should not be more than 20%, and at other time points should not be more than 10%.
• For curves to be considered similar, f1 values should be close to 0, and f2 values should be close to 100. Generally, f1 values up to 15 (0-15) and f2 values greater than 50 (50-100) ensure sameness or equivalence of the two curves and, thus, of the performance of the test and reference products.
• Most countries recommend that where more than 85% of the drug is dissolved for both the test and reference products within 15 min, dissolution profiles may be accepted as similar without further mathematical evaluation.

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