TRRT.RTTR.TTRR.RRTT {replicateBE}

Reference Dataset for TRRT|RTTR|TTRR|RRTT Designs

Description

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

Format

• Reference Dataset 24
  40 subjects (one completely missing).
  Unbalanced (nine subjects in sequence TRRT and ten in each of the other three) and complete. Two outliers (subject 3 in sequence RTTR and subject 30 in sequence TTRR).
  A data frame with 160 observations on the following 5 variables:

  rds24

  subject	a factor with 40 levels: 1, 2, ..., 932
  period	a factor with 4 levels: 1, 2, 3, 4
  sequence	a factor with 4 levels: TRRT, RTTR, TTRR, RRTT
  treatment	a factor with 2 levels: T, R
  PK	a numeric vector of pharmacokinetic responses acceptable for reference-scaling (here Cmax)

Details

Dataset	N	CVwR (%)	Evaluation
rds24	39	>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", "RTTR", "TRRT", "TTRR" and treatment as "R", "T". In BE – by convention – sequences are ordered with T first. The package follows this convention.

Source

Dataset	Origin	Description
rds24	FDA, CDER	Cmax data of Drug 1.

References

U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Bioequivalence Studies. Rockville, 1997. bioequivalence study files (archived 2017-07-23)

Examples

str(rds24)
row <- c(13:16, 9:12, 1:4, 5:8)
rds24[row, ]
summary(rds24[2:5])