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Abstract:
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Estimation of power and sample size in comparability studies is critical to examine the effect of changes in drug development. However, for large molecules, challenges arise when large samples in analytical studies and data balance in stability studies are not feasible. In addition, it’s often expected to incorporate prespecified constraints in covariates and maximum acceptable mean differences. Four examples are used to illustrate the problems and associated methods in comparisons of stability profiles, method bridging, and analytical linearity and co-validation. The results and future research are discussed.
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