An iterative method to protect the type I error rate in bioequivalence studies under two‐stage adaptive 2×2 crossover designs - Molins, Eduard; Labes, Detlew; Schütz, Helmut; Cobo, Erik; Ocaña, Jordi (Biometrical journal, 2021)
Keywords: average bioequivalence (ABE); Bioequivalence; Clinical trials; Coefficient of variation; Cross-Over Studies; generic drug product; Humans; Iterative methods; Pharmacokinetics; Regulatory agencies; Research Design; Sample Size; significance level adjustment; Therapeutic Equivalency; two‐stage adaptive designs (TSD); type I error control (T1E); Variability; average bioequivalence (ABE); type I error control (T1E); two-stage adaptive designs (TSD); generic drug product; significance level adjustment