man/examples/examples_summary.expirest_osle.R

# 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.

\dontrun{
  summary(res1)
  # Expected output of summary(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

  summary(res2)
  # Expected output of summary(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

  summary(res3)
  # Expected output of summary(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
}

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expirest documentation built on April 4, 2025, 2:41 a.m.