Abstract
This chapter provides an overview of the statistical analysis of in vivo or in vitro bioequivalence (BE) studies that are part of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. This chapter discusses three approaches for comparisons based on equivalence criteria: average, population, and individual BE. It focuses on the statistical model, study design, appropriate sample size, and interpretation for each of the three approaches. Further, it describes possible statistical analysis methods, which depend on the design of the BE study, the “two one-sided tests” hypothesis testing framework, and the need for logarithmic transformation of the pharmacokinetic measurements and derived values. It also outlines other statistical issues that must be taken into consideration in the conduct, analysis and interpretation of BE studies.
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Makhlouf, F.T., Grosser, S.C., Schuirmann, D.J. (2014). Basic Statistical Considerations. In: Yu, L., Li, B. (eds) FDA Bioequivalence Standards. AAPS Advances in the Pharmaceutical Sciences Series, vol 13. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1252-0_3
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DOI: https://doi.org/10.1007/978-1-4939-1252-0_3
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