Description Usage Arguments Details Value Note Author(s) References See Also Examples

Calculates the power of the test of equivalence of the ratio of two means
with normality on original scale.

This test is based on Fieller’s confidence (‘fiducial’) interval and Sasabuchi’s
test (a TOST procedure as well).

1 2 | ```
power.RatioF(alpha = 0.025, theta1 = 0.8, theta2, theta0 = 0.95,
CV, CVb, n, design = "2x2", setseed=TRUE)
``` |

`alpha` |
Type I error probability, aka significance level. |

`theta1` |
Lower bioequivalence limit. Typically 0.8 (default). |

`theta2` |
Upper bioequivalence limit. Typically 1.25. |

`theta0` |
‘True’ or assumed T/R ratio. Typically set to 0.95 for planning. |

`CV` |
Coefficient of variation as ratio. In case of |

`CVb` |
CV of the between-subject variability. Only necessary for |

`n` |
Number of subjects to be planned. |

`design` |
A character string describing the study design. |

`setseed` |
If set to |

The power is calculated exact using the bivariate non-central *t*-distribution
via function `pmvt`

of the package `mvtnorm`

.

Due to the calculation method of the used package mvtnorm – randomized
Quasi-Monte-Carlo – these probabilities are dependent from the state of the
random number generator within the precision of the power.
See argument `setseed`

.

Value of power according to the input.

This function is intended for studies with clinical endpoints where the 95% confidence intervals are usually used for equivalence testing.

Therefore, alpha defaults here to 0.025 (see EMEA 2000).

The formulas given in the references rely on the assumption of equal variances
in the two treatment groups for the parallel group design or on assuming equal
within-subject and between-subject variabilities for the 2×2 crossover design.

D. Labes

Fieller EC. *Some Problems in Interval Estimation.* J Royal Stat Soc B. 1954;16(2):175–85. doi: 10.1111/j.2517-6161.1954.tb00159.x

Sasabuchi S. *A test of a multivariate normal mean with composite hypotheses determined by linear inequalities.* Biometrika. 1980;67(2):429–39. doi: 10.1093/biomet/67.2.429

Hauschke D, Kieser M, Diletti E, Burke M. *Sample size determination for proving equivalence based on the ratio of two means for normally distributed data.* Stat Med. 1999;18(1):93–105.

Hauschke D, Steinijans V, Pigeot I. *Bioequivalence Studies in Drug Development.* Chichester: Wiley; 2007. Chapter 10.

European Agency for the Evaluation of Medicinal Products, CPMP. *Points to Consider on Switching between Superiority and Non-Inferiority.* London, 27 July 2000. CPMP/EWP/482/99

1 2 3 4 5 6 | ```
# power for alpha=0.025, ratio0=0.95, theta1=0.8, theta2=1/theta1=1.25
# within-subject CV=0.2, between-subject CV=0.4
# 2x2 crossover study, n=24
# using all the defaults:
power.RatioF(CV = 0.2, CVb = 0.4, n = 24)
# gives [1] 0.7315357
``` |

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