TTRR.RRTT: Reference Datasets for TTRR|RRTT Designs

In replicateBE: Average Bioequivalence with Expanding Limits (ABEL)

Reference Datasets for TTRR|RRTT Designs

Description

Dataset obtained by simulations to be evaluated by method.A() and/or method.B().

Format

• Reference Dataset 28
  64 subjects. Balanced (64 subjects in both sequences) and complete. No outliers.
  A data frame with 256 observations on the following 5 variables:

  rds28

  subject	a factor with 64 levels: 1, 2, ..., 64
  period	a factor with 4 levels: 1, 2, 3, 4
  sequence	a factor with 2 levels: TTRR, RRTT
  treatment	a factor with 2 levels: T, R
  PK	a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally Cmax)

Details

Dataset	N	CVwR (%)	Evaluation
rds28	64	<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 "RRTT", "TTRR" and treatment as "R", "T". In BE – by convention – sequences are ordered with T first. The package follows this convention.

Author(s)

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

Source

Dataset	Origin	Description
rds28	R	Simulated with CVwT = CVwR = 35%, CVbT = CVbR = 75%, GMR 0.90.

Examples

str(rds28)
summary(rds28[1:5])

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