Letter to the Editor on “Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies”
Author:
Publisher
Springer Science and Business Media LLC
Link
https://link.springer.com/content/pdf/10.1208/s12248-024-00972-0.pdf
Reference10 articles.
1. Schutz H, et al. Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies. AAPS J. 2024;26:50. https://doi.org/10.1208/s12248-024-00921-x.
2. Sun W, Schuirmann D, Grosser S. Qualitative versus quantitative treatment-by-subgroup interaction in equivalence studies with multiple subgroups. Stat Biopharm Res. 2023;15(4):737–47.
3. Murdoch D, Tsai Y, Adcock J. P-Values are Random Variables. Am Stat. 2008;62:242–5.
4. Alosh M, Huque MF, Koch GG. Statistical perspectives on subgroup analysis: testing for heterogeneity and evaluating error rate for the complementary subgroup. J Biopharm Stat. 2015;25:1161–78.
5. FDA. Statistical Approaches to Establishing Bioequivalence Draft Guidance for Industry, December 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence.
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