package replicateBE on CRAN [🇷 for BE/BA]
![[image]](img/uploaded/image612.png)
package
replicateBE
is on CRAN. Background information in its Vignette.Data can be imported from CSV- or XLS(X)-files. Following ten designs are covered:
- Four period full replicates
- TRTR | RTRT
- TRRT | RTTR
- TTRR | RRTT
- TRTR | RTRT | TRRT | RTTR
- TRRT | RTTR | TTRR | RRTT
- TR | RT | TT | RR 1
- TRT | RTR
- TRR | RTT
- TRR | RTR | RRT
- TRR | RTR 2
- Estimation of CVwR (and CVwT in full replicates)
A linear model of log-transformed PK responses and effects
sequence, subject(sequence), period
of the reference (and test, if possible) treatment – where all effects are fixed (i.e., ANOVA).
Estimated via functionlm()
of librarystats
.
In full replicate designs assessment of \(s_{wT}/s_{wR}\) and the upper confidence limit of \(\sigma_{wT}/\sigma_{wR}\) for the WHO’s reference-scaling of AUC.
- Method A
A linear model of log-transformed PK responses and effects
sequence, subject(sequence), period, treatment
– where all effects are fixed (i.e., ANOVA).
Estimated via functionlm()
of librarystats
.
- Method B
A linear mixed model of log-transformed PK responses and effects
sequence, subject(sequence), period, treatment
– where subject(sequence) is a random effect and all others are fixed.
Three options - Estimated via function
lme()
of librarynlme
. Uses degrees of freedom equivalent to SAS’DDFM=CONTAIN
and Phoenix/WinNonlin’sDF Residual
. Implicitly preferred according to the EMA’s Q&A document and hence, the default.
- Estimated via function
lmer()
of librarylmerTest
. Uses Satterthwaite’s degrees of freedom equivalent to SAS’DDFM=SATTERTHWAITE
and Phoenix/WinNonlin’sDF Satterthwaite
. This is the only option available in SPSS.
Potentially better for highly incomplete data.
- Estimated via function
lmer()
of librarylmerTest
. Uses the Kenward-Roger approximation equivalent to SAS’DDFM=KENWARDROGER
. This is the only option available in JMP.
Potentially better for highly incomplete data.
- ABE
Conventional Average Bioequivalence. Optionally with tighter (EMA: NTIDs) or wider limits (GCC: Cmax).
Installation/Update of the latest release from CRAN with
install.packages("replicateBE", repos = "https://cloud.r-project.org/")
devtools::install_github("Helmut01/replicateBE")
Enjoy!
Bug reports to GitHub or the maintainer.
- Balaam’s design (not recommended due to poor power characteristics).
- Extra-reference design; biased in the presence of period effects (design not recommended).
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- package replicateBE on CRANHelmut 2019-06-14 18:01 [🇷 for BE/BA]