package replicateBE on CRAN [🇷 for BE/BA]
Dear all,
package
Data can be imported from CSV- or XLS(X)-files. Following ten designs are covered:Two period full replicate Three period full replicates Three period partial replicates Implemented:
Installation/Update of the latest release from CRAN with
Enjoy!
Bug reports to GitHub or the maintainer.
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!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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]