adaptIVPT

CRANadaptIVPTMaRDI QIDQ91174FDOQ91174

Adaptive Bioequivalence Design for In-Vitro Permeation Tests

Daeyoung Lim

Last update: 26 January 2024

Copyright license: GNU General Public License

Software version identifier: 1.0.0, 1.1.0

Description

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procedures based on parallel replicate design and balanced data, according to the U.S. Food and Drug Administration's "Draft Guidance on Acyclovir" 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.

Cites work

• Adaptive designs for IVPT data with mixed scaled average bioequivalence
• Sequential design approaches for bioequivalence studies with crossover designs

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