TRR.RTR: Reference Dataset for TRR|RTR (extra-reference) Designs

In replicateBE: Average Bioequivalence with Expanding Limits (ABEL)

Reference Dataset for TRR|RTR (extra-reference) Designs

Description

Dataset simulated to be evaluated by method.A(), method.B().

Usage

rds22

Format

• Reference dataset 22
  Simulated with CV_wT = CV_wR = 45%, CV_bT = CV_bR = 100% GMR 0.90. 42 subjects.
  Balanced (21 subjects in each of the sequences) and complete (no missing data). No outliers.
  A data frame with 126 observations on the following 5 variables:

  rds22

  subject	a factor with 42 levels: 1, 2, ..., 42
  period	a factor with 3 levels: 1, 2, 3
  sequence	a factor with 2 levels: TRR, RTR
  treatment	a factor with 2 levels: T, R
  PK	a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally Cmax)
  logPK	a numeric vector of the natural logarithms of PK

Details

Dataset	N	CwR (%)	Evaluation
rds22	42	>30	method.A(), method.B()

Note

In software sequences and treatments are ranked in lexical order. Hence, executing str() or summary() will show sequence as "RTR", "TRR" and treatment as "R", "T". In BE – by convention – sequences are ordered with T first. The package follows this convention.
This partial replicate design is also known as the ‘extra-reference design’. Since the Test is not administered in all periods, lacking period effects must be assumed. In the presence of true period effects the treatment comparison will be biased. Hence, this design is not recommended.

Author(s)

Helmut Schütz (R-code for simulations by Detlew Labes)

Source

Dataset	Origin	Description
rds22	R	Simulated with homoscedasticity.

Examples

str(rds22)
rds22[61:66, ]
summary(rds22[2:5])

replicateBE documentation built on May 3, 2022, 1:06 a.m.