Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles
Abstract Background and objectives: The most widely used method to compare dissolution profiles is the similarity factor f 2 . When this method is not applicable, the confidence interval of f 2 using bootstrap methodology has been recommended instead. As neither details of the estimator nor the types of confidence intervals are described in the guidelines, the suitability of five estimators and fourteen types of confidence intervals were investigated in this study by simulation. Methods: One million individual dissolution profiles were simulated for the reference and test populations with predefined target population f 2 values, where random samples of different sizes were drawn without rep…
Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms
Inter- and intra-batch variability of the quality attributes contribute to the uncertainty for demonstrating equivalent microstructure of post-approval changes and generic/hybrids of semisolid topical products. Selecting a representative sample size to describe accurately the in vitro properties of semisolids and to reach enough statistical power to demonstrate similarity between two semisolid topical products is currently challenging. The objective of this work is to establish the number of batches and units per batch to be compared based on different inter-batch and intra-batch variability to demonstrate equivalence in the physical characteristics of the products that ensure a similar mic…