adaptIVPT

• adaptIVPT is an R package that will help you design and analyze in vitro permeation test (IVPT) data (currently supports parallel replicate design and balanced data).
• This package contains 4 functions:
  • msabe for hypothesis testing (mixed-scaled average bioequivalence)
  • prms for calculating passing rates (passing rate mixed scaled)
  • rss for reestimating sample size (hence adaptive design)
  • PRsurface for plotting passing-rate surfaces (passing-rate surface)

References

• Draft Guidance on Generic 5% Acyclovir Cream
• In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
• Davit, B. M., Chen, M. L., Conner, D. P., Haidar, S. H., Kim, S., Lee, C. H., Lionberger, R. A., Makhlouf, F. T., Nwakama, P. E., Patel, D. T., Schuirmann, D. J., & Yu, L. X. (2012). Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration. The AAPS journal, 14(4), 915-924. (link)
• Potvin, D., DiLiberti, C. E., Hauck, W. W., Parr, A. F., Schuirmann, D. J., & Smith, R. A. (2008). Sequential design approaches for bioequivalence studies with crossover designs. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry, 7(4), 245-262. (link)
• Lim, D., Rantou, E., Kim, J., Choi, S., Choi, N. H., & Grosser, S. (2023). Adaptive designs for IVPT data with mixed scaled average bioequivalence. Pharmaceutical Statistics, 22(6), 1116-1134. (link)

Installation

install.packages("adaptIVPT")

Getting help

If you encounter a clear bug, please file an issue with a minimal reproducible example on GitHub. For questions and other discussion, please email the maintainer.

Authors

• Daeyoung Lim Daeyoung.Lim@fda.hhs.gov
• Elena Rantou Elena.Rantou@fda.hhs.gov
• Jessica Kim Jessica.Kim@fda.hhs.gov
• Sungwoo Choi Sungwoo.Choi@fda.hhs.gov
• Nam Hee Choi NamHee.Choi@fda.hhs.gov
• Stella Grosser Stella.Grosser@fda.hhs.gov

⚠️ Disclaimer

This package reflects the views of the authors and should not be construed to represent the FDA's views or policies.