TRR.RTT: Reference Dataset for TRR|RTT Replicate Designs

In replicateBE: Average Bioequivalence with Expanding Limits (ABEL)

Reference Dataset for TRR|RTT Replicate Designs

Description

Dataset from the public domain to be evaluated by method.A(), method.B(), or ABE().

Usage

rds10

Format

• Reference Dataset 10
  18 subjects.
  Balanced (nine subjects in both sequences) and complete. No outliers.
  A data frame with 54 observations on the following 5 variables:

  rds10

  subject	a factor with 18 levels: 1, 2, ..., 18
  period	a factor with 3 levels: 1, 2, 3
  sequence	a factor with 2 levels: TRR, RTT
  treatment	a factor with 2 levels: T, R
  PK	a numeric vector of pharmacokinetic responses (here AUC)

Details

Dataset	N	CVwR (%)	Evaluation
rds10	36	<30	method.A(), method.B(), ABE()

Note

In software sequences and treatments are ranked in lexical order. Hence, executing str() or summary() will show sequence as "RTT", "TRR" and treatment as "R", "T". In BE – by convention – sequences are ordered with T first. The package follows this convention.
In analogy to the EMA’s Q&A: Uncertain estimate of CVwR since less than twelve subjects in sequence TRR.

Source

Dataset	Origin	Description
rds10	Chow & Liu	AUC data given in Table 9.3.3.

References

Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. Boca Raton: CRC Press; 3^rd edition 2009. p275.

Examples

str(rds10)
row <- c(1:3, 28:30)
rds10[row, ]
summary(rds10[2:5])

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