Can you please explain the calculation of f2 value in dissolution profile with one example?
Answer:
A specific procedure to determine difference and similarity factors is as follows:
1. Determine the dissolution profile of two products (12 units each) of the test (postchange) and reference (prechange) products.
2. Using the mean dissolution values from both curves at each time interval,calculate the difference factor (f ) and similarity factor (f ) using the equations.
3. For curves to be considered similar, f values should be close to 0, and f 1 2 values should be close to 100. Generally, f values up to 15 (0-15) and f values 1 2
greater than 50 (50-100) ensure sameness or equivalence of the two curves and,thus, of the performance of the test (postchange) and reference (prechange)
products.
This model independent method is most suitable for dissolution profile comparison when three to four or more dissolution time points are available. As further
suggestions for the general approach, the following recommendations should also be considered:
! 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). The reference batch used should be the most recently manufactured prechange
product.
! Only one measurement should be considered after 85% dissolution of both the products.
! To allow use of mean data, the percent coefficient of variation 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%.
! The mean dissolution values for R can be derived either from (1) last t prechange (reference) batch or (2) last two or more consecutively manufactured prechange batches.
B. Model Independent Multivariate Confidence Region Procedure
In instances where within batch variation is more than 15% CV, a multivariate model independent procedure is more suitable for dissolution profile comparison. The following
steps are suggested:
1. Determine the similarity limits in terms of multivariate statistical distance (MSD) based on interbatch differences in dissolution from reference (standard approved) batches.
2. Estimate the MSD between the test and reference mean dissolutions.
3. Estimate 90% confidence interval of true MSD between test and reference batches.
4. Compare the upper limit of the confidence interval with the similarity limit. The test batch is considered similar to the reference batch if the upper limit of the confidence interval is less than or equal to the similarity limit.
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