replicateBE (version 1.1.3)

refdata: Reference Datasets

Description

Datasets of replicate designs from the public domain, edited, or obtained by simulations to be evaluated by method.A(), method.B(), or ABE().

Details

Design	Specification	Dataset	N	(%)	Evaluation
TRTR|RTRT	full	rds01	77	>30	method.A(), method.B()
TRTR|RTRT	full	rds06	77	>30	method.A(), method.B()
TRTR|RTRT	full	rds12	77	>30	method.A(), method.B()
TRTR|RTRT	full	rds14	77	>30	method.A(), method.B()
TRTR|RTRT	full	rds18	77	>30	method.A(), method.B()
TRTR|RTRT	full	rds21	77	>30	method.A(), method.B()
TRTR|RTRT	full	rds19	61	>30	method.A(), method.B()
TRTR|RTRT	full	rds20	61	>30	method.A(), method.B()
TRTR|RTRT	full	rds08	222	>30	method.A(), method.B()
TRTR|RTRT	full	rds09	222	>30	method.A(), method.B()
TRTR|RTRT	full	rds13	222	>30	method.A(), method.B()
TRTR|RTRT	full	rds15	222	>30	method.A(), method.B()
TRTR|RTRT	full	rds25	70	>30	method.A(), method.B()
TRTR|RTRT	full	rds29	12	<30	method.A(), method.B(), ABE()
TRRT|RTTR	full	rds26	54	>30	method.A(), method.B()
TRRT|RTTR	full	rds05	26	<30	method.A(), method.B(), ABE()
TRRT|RTTR	full	rds11	37	>30	method.A(), method.B()
TRRT|RTTR	full	rds16	38	>30	method.A(), method.B()
TTRR|RRTT	full	rds28	64	<30	method.A(), method.B(), ABE()
TRTR|RTRT|TRRT|RTTR	full	rds23	22	>30	method.A(), method.B()
TRRT|RTTR|TTRR|RRTT	full	rds24	39	>30	method.A(), method.B()
TRT|RTR	full	rds03	77	>30	method.A(), method.B()
TRT|RTR	full	rds17	19	>30	method.A(), method.B()
TRR|RTT	full	rds10	18	<30	method.A(), method.B(), ABE()
TR|RT|TT|RR	Balaam<U+2019>s	rds27	312	>30	method.A(), method.B()
TRR|RTR|RRT	partial	rds02	24	<30	method.A(), method.B(), ABE()
TRR|RTR|RRT	partial	rds04	51	>30	method.A(), method.B()
TRR|RTR|RRT	partial	rds07	360	>30	method.A(), method.B()
TRR|RTR|RRT	partial	rds30	14	<30	method.A(), method.B(), ABE()

In full replicate designs both R and T are administered twice (in 3-period designs to <U+00BD> of the subjects). Balaam<U+2019>s design is a mixture of a conventional crossover (<U+00BD> of the subjects) and a replicate design (<U+00BC> of the subjects receive either R or T twice). In partial replicate designs only R is administered twice.

References

European Medicines Agency. London, 21 September 2016. Annex II, Annex III.

Patterson SD, Jones B. Viewpoint: observations on scaled average bioequivalence. Pharm Stat. 2012; 11(1): 1--7. 10.1002/pst.498

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

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

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

Patterson SD, Jones B. Bioequivalence and Statistics in Clinical Pharmacology. Boca Raton: CRC Press; 2 edition 2016. p105--6.

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

See Also

4-period full replicates TRTR.RTRT, TRRT.RTTR, TTRR.RRTT, TRTR.RTRT.TRRT.RTTR, TRRT.RTTR.TTRR.RRTT 2-period replicate (Balaam<U+2019>s design) TR.RT.TT.RR 3-period full replicates TRT.RTR, TRR.RTT 3-period partial replicates TRR.RTR.RRT, TRR.RTR

Examples

# NOT RUN {
# show structure of all data sets
ds <- substr(grep("rds", unname(unlist(data(package = "replicateBE"))),
                  value = TRUE), start = 1, stop = 5)
for (i in seq_along(ds)) {
  cat(ds[i], "\n")
  str(eval(parse(text = ds[i])))
}
# }