Updated Clinical Pharmacology and Pharmacokinetics: Questions and Answers

On 16 February 2022 the EMA published updated Q&A guidance on expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor.

Q&A section 3.11 describes expectations for conducting and reporting bootstrap methodology. The use of two-sided 90% confidence interval of f2 is the recommended methodology for dissolution comparison when highly variable conditions occur, since the use of f2 could be highly influenced by the experimental dissolution data and might not represent the population (true) f2.

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