Abstract
Dissolution (or in vitro release) studies play an important role during pharmaceutical drug development. They are useful as a quality control tool, establishing an IVIVC, justifying a biowaiver and supporting equivalence between generics and innovator products. This chapter provides an overview of regulatory guidances related to dissolution testing. The important question of dissolution profile comparisons and the challenges of defining similarity are discussed. The limitations of the f 2 statistic, a regulatory driven test, are described, with emphasis on the lack of a statistical basis for the test. The strengths and weaknesses of alternative approaches are described. A Bayesian test procedure is given that mitigates to a large extent the weaknesses of other approaches by providing a coherent connection between a parameter defining “fit for use” to a statistical probability statement of similarity.
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LeBlond, D. (2016). In Vitro Dissolution Testing: Statistical Approaches and Issues. In: Zhang, L. (eds) Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-23558-5_23
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