Adaptive Bioequivalence Design for In-Vitro Permeation Tests
adaptIVPT: Adaptive Bioequivalence Design for In-Vitro Permeation Test...
Run the mixed scaling approach in bioequivalence (BE) studies
Compute the passing rate for the mixed scaling approach in bioequivale...
Plot the passing-rate curve and the passing-rate surface in IVPT
Reestimate the sample size for the adaptive design in bioequivalence (...
summary method for class "msabe"
Contains functions carrying out adaptive procedures using mixed scaling approach to establish bioequivalence for in-vitro permeation test (IVPT) data. Currently, the package provides procedures based on parallel replicate design and balanced data, according to the U.S. Food and Drug Administration's "Draft Guidance on Acyclovir" <https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_topical%20cream_RLD%2021478_RV12-16.pdf>. Potvin et al. (2008) <doi:10.1002/pst.294> provides the basis for our adaptive design (see Method B). For a comprehensive overview of the method, refer to Lim et al. (2023) <doi:10.1002/pst.2333>. This package reflects the views of the authors and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.