Comparative BA-calculation for the EMA's Average Bioequivalence with Expanding Limits (ABEL)
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Updated
May 4, 2022 - R
Comparative BA-calculation for the EMA's Average Bioequivalence with Expanding Limits (ABEL)
FARTSSIE is a free sample size calculator for various types of clinical trials (superiority, non-inferiority, equivalence, bioequivalence, etc.).
Operational characteristics of BE studies in 2-stage designs via simulations.
Finite sample correction methods for equivalence testing procedures
Finite Sample Correction of The TOST in The Univariate Framework
The method presented is used by pharmaceutical regulatory authorities to detect data manipulation in clinical trials (bioequivalence). The code shown makes it possible to use the PK data of a clinical study to determine which blood samples may have been illegally reanalysed in order to positively influence the result of the study.
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