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When comparing the dissolution data of a test product to a reference product, the goal is to assess the similarity between mean percent dissolution dissolved at the observed sample time points. Several criteria for assessment of similarity between two dissolution profiles are investigated. There are similarity factor f2, and metrics based on the mean square distance and the mean absolute difference. Statistical issues of similarity factor include complex and intractable nature of the distribution for f2, and liberality in concluding similarity. This research conducts several simulation for comparing f2 to other metrics based on mean squared distance. We also examine the concept of mean absolute difference and propose an alternative method g factor, for assessment of the similarity. We apply Bootstrap technique to obtain its sampling distribution. A simulation is conducted to compare the empirical size and power between f2 and g factor.
Keywords: Dissolution, Similarity, Bootstrap technique, Power, Absolute Mean Difference
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