TRT.RTR: Reference Datasets for TRT|RTR Replicate Designs

In replicateBE: Average Bioequivalence with Expanding Limits (ABEL)

Reference Datasets for TRT|RTR Replicate Designs

Description

Datasets from the public domain and edited to be evaluated by method.A() and/or method.B().

Format

• Reference dataset 03
  Based on rds01. Removed all data of period 4. 77 subjects.
  Unbalanced (39 subjects in sequence TRT and 38 in RTR) and incomplete (six missings in sequence TRT and two in RTR). Missings / period: 0/1, 1/2, 7/3. Two outliers (subjects 45 and 52) in sequence RTR.
  A data frame with 223 observations on the following 6 variables:

  rds03

  subject	a factor with 77 levels: 1, 2, ..., 78
  period	a factor with 3 levels: 1, 2, 3
  sequence	a factor with 2 levels: TRT, RTR
  treatment	a factor with 2 levels: T, R
  PK	a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally Cmax)

• Reference dataset 17
  Based on rds03. 19 subjects.
  Unbalanced (seven subjects in sequence TRT and twelve in RTR) and incomplete (one missing in sequence TRT). Missings / period: 0/1, 0/2, 1/3. One outlier (subject 18) in sequence RTR.
  A data frame with 56 observations on the following 6 variables:

  rds17

  subject	a factor with 19 levels: 1, 2, ..., 22
  period	a factor with 3 levels: 1, 2, 3
  sequence	a factor with 2 levels: TRT, RTR
  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
rds03	77	>30	method.A(), method.B()
rds17	19	>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", "TRT" and treatment as "R", "T". In BE – by convention – sequences are ordered with T first. The package follows this convention.

Author(s)

Helmut Schütz

Source

Dataset	Origin	Description
rds03	rds01 edited	Period 4 removed.
rds17	rds03 edited	Highly unbalanced (seven subjects in TRT and twelve in RTR).

Examples

head(rds03, 6)
summary(rds03[2:5])

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