print.expirest_osle {expirest} | R Documentation |
Print a summary of the shelf life estimation (osle)
Description
This is a method for the function print()
for objects of class
‘expirest_osle
’.
Usage
## S3 method for class 'expirest_osle'
print(x, ...)
Arguments
x |
An object of class ‘ |
... |
Further arguments passed to or from other methods or arguments
that can be passed down to the |
Details
The function expirest_osle()
estimates the shelf
life, or retest period, following the ICH Q1E guideline. By default, batch
poolability is checked as recommended by the guideline at a significance
level of 0.25. Other levels can be used, although not recommended, by
changing the default of the alpha_pool
parameter. Three possible
models may be appropriate, i.e.
a common intercept / common slope model (cics),
a different intercept / common slope model (dics) or
a different intercept / different slope model (dids).
The worst case intercept is the intercept of the batch whose confidence
limit is the first crossing the acceptance limit. As in case of the
cics
model type all batches have a common intercept and a common
confidence interval, all batches can be regarded as equally worst case. In
case of the dids
model type, shelf life estimation is done using the
models obtained from fitting the data of each batch individually.
Value
The ‘expirest_osle
’ object passed to the x
parameter is returned invisibly.
See Also
expirest_osle
, expirest_wisle
,
formatC
, methods
.
Examples
# Fit models of different type
res1 <-
expirest_osle(data = exp1[exp1$Batch %in% c("b2", "b5", "b7"), ],
response_vbl = "Potency", time_vbl = "Month",
batch_vbl = "Batch", sl = 95, sl_sf = 3,
srch_range = c(0, 500), sf_option = "loose")
res2 <-
expirest_osle(data = exp1[exp1$Batch %in% c("b3", "b4", "b5"), ],
response_vbl = "Potency", time_vbl = "Month",
batch_vbl = "Batch", sl = 95, sl_sf = 3,
srch_range = c(0, 500), sf_option = "loose")
res3 <-
expirest_osle(data = exp1[exp1$Batch %in% c("b4", "b5", "b8"), ],
response_vbl = "Potency", time_vbl = "Month",
batch_vbl = "Batch", sl = 95, sl_sf = 3,
srch_range = c(0, 500), sf_option = "loose")
# The parameter settings sf_option = "loose" and ivl_side = "lower" (the
# default setting of ivl_side) cause the specification limit of 95.0
# (sl_sf = 3, i.e. 3 significant digits) to be reduced by 0.05, i.e. the
# actual specification limit is 94.95.
## Not run:
res1
# Expected output of print(res1)
# Summary of shelf life estimation following the ICH Q1E guideline
#
# The best model accepted at a significance level of 0.25 has
# Common intercepts and Common slopes (acronym: cics).
#
# Worst case intercept: 100.5669 (Potency)
# Worst case batch: NA
# Estimated shelf life for cics model: 26.2241 (Month)
#
# Worst case intercepts, POIs and batches of all models
# (Including information about the side where the confidence
# interval crosses the specification boundary):
# Intercept POI Side Batch
# cics 100.5669 26.2241 lower NA
# dics 100.3638 24.8003 lower b2
# dids.pmse 100.7819 23.66724 lower b5
# dids 100.7819 23.34184 lower b5
res2
# Expected output of print(res2)
# Summary of shelf life estimation following the ICH Q1E guideline
#
# The best model accepted at a significance level of 0.25 has
# Different intercepts and Common slopes (acronym: dics).
#
# Worst case intercept: 100.82 (Potency)
# Worst case batch: b5
# Estimated shelf life for dics model: 23.60194 (Month)
#
# Worst case intercepts, POIs and batches of all models
# (Including information about the side where the confidence
# interval crosses the specification boundary):
# Intercept POI Side Batch
# cics 102.0513 29.18093 lower NA
# dics 100.82 23.60194 lower b5
# dids.pmse 100.7819 22.49726 lower b5
# dids 102.3841 23.26251 lower b3
res3
# Expected output of print(res3)
# Summary of shelf life estimation following the ICH Q1E guideline
#
# The best model accepted at a significance level of 0.25 has
# Different intercepts and Different slopes (acronym: dids).
#
# Worst case intercept: 101.2594 (Potency)
# Worst case batch: b8
# Estimated shelf life for dids model: 15.96453 (Month)
#
# Worst case intercepts, POIs and batches of all models
# (Including information about the side where the confidence
# interval crosses the specification boundary):
# Intercept POI Side Batch
# cics 101.5498 28.12518 lower NA
# dics 100.4882 22.47939 lower b8
# dids.pmse 101.2594 15.72348 lower b8
# dids 101.2594 15.96453 lower b8
## End(Not run)