replicateBE (version 1.1.3)

TRRT.RTTR: Reference Datasets for TRRT|RTTR Replicate Designs

Description

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

Format

• Reference Dataset 05 26 subjects. Balanced (13 subjects in both sequences) and complete. No outliers. A data frame with 104 observations on the following 5 variables:

  rds05

  subject	a factor with 26 levels: 1, 2, …, 26
  period	a factor with 4 levels: 1, 2, 3, 4
  sequence	a factor with 2 levels: TRRT, RTTR
  treatment	a factor with 2 levels: T, R

  In the source evaluated by SAS with the FDA<U+2019>s mixed effects model (termed Method C by the EMA; not compatible with the guideline). Reported results:

  SAS Proc Mixed

  CVwR	5.47%
  CVwT	6.75%
  PE	107.90%

• Reference Dataset 11 37 subjects. Unbalanced (18 subjects in sequence TRRT and 19 subjects in RTTR) and complete. No outliers. A data frame with 148 observations on the following 5 variables

  rds11

  subject	a factor with 37 levels: 1, 2, …, 37
  period	a factor with 4 levels: 1, 2, 3, 4
  sequence	a factor with 2 levels: TRRT, RTTR
  treatment	a factor with 2 levels: T, R

  In the source evaluated by SAS with the FDA<U+2019>s mixed effects model (termed Method C by the EMA; not compatible with the guideline). Reported results:

  SAS Proc MIXED

  PE

  90.0%

• Reference Dataset 16 38 subjects. Unbalanced (18 subjects in sequence TRRT and 20 in RTTR) and complete. No outliers. A data frame with 152 observations on the following 5 variables:

  rds16

  subject	a factor with 38 levels: 1, 2, …, 38
  period	a factor with 4 levels: 1, 2, 3, 4
  sequence	a factor with 2 levels: TRRT, RTTR
  treatment	a factor with 2 levels: T, R

Details

Dataset	N	(%)	Evaluation
rds05	26	<30	method.A(), method.B(), ABE()
rds11	37	>30	method.A(), method.B()

References

Shumaker RC, Metzler CM. The Phenytoin Trial is a Case Study of ‘Individual’ Bioequivalence. Drug Inf J. 1998; 32(4): 1063--72. 10.1177/009286159803200426

Hauschke D, Steinijans VW, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007. p216.

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

Examples

# NOT RUN {
str(rds05)
summary(rds05[2:5])
head(rds11, 8)
# }