man/examples/examples_print.expirest_wisle.R

In expirest: Expiry Estimation Procedures

# Fit models of different type
res1 <-
  expirest_wisle(data = exp1[exp1$Batch %in% c("b2", "b5", "b7"), ],
                 response_vbl = "Potency", time_vbl = "Month",
                 batch_vbl = "Batch", rl = 98, rl_sf = 3, sl = 95,
                 sl_sf = 3, srch_range = c(0, 500), sf_option = "loose")

res2 <-
  expirest_wisle(data = exp1[exp1$Batch %in% c("b3", "b4", "b5"), ],
                 response_vbl = "Potency", time_vbl = "Month",
                 batch_vbl = "Batch", rl = 98, rl_sf = 3, sl = 95,
                 sl_sf = 3, srch_range = c(0, 500), sf_option = "loose")
res3 <-
  expirest_wisle(data = exp1[exp1$Batch %in% c("b4", "b5", "b8"), ],
                 response_vbl = "Potency", time_vbl = "Month",
                 batch_vbl = "Batch", rl = 98, rl_sf = 3, 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{
  res1
  # Expected output of print(res1)
  # Summary of shelf life estimation following the ARGPM
  # guidance "Stability testing for prescription medicines"
  #
  # The best model accepted at a significance level of 0.25 has
  # Common intercepts and Common slopes (acronym: cics).
  #
  # Worst case intercept and batch:
  #   RL Batch Intercept
  # 1 98    NA  100.5669
  #
  # Estimated shelf lives for the cics model:
  #   SL RL    wisle    osle
  # 1 95 98 14.07398 26.2241
  #
  # Abbreviations:
  #   ARGPM: Australian Regulatory Guidelines for Prescription Medicines;
  #   ICH: International Council for Harmonisation;
  #   osle: Ordinary shelf life estimation (i.e. following the ICH guidance);
  #   RL: Release Limit;
  #   SL: Specification Limit;
  #   wisle: What-if (approach for) shelf life estimation (see ARGPM guidance).

  res2
  # Expected output of print(res2)
  # Summary of shelf life estimation following the ARGPM
  # guidance "Stability testing for prescription medicines"
  #
  # The best model accepted at a significance level of 0.25 has
  # Different intercepts and Common slopes (acronym: dics).
  #
  # Worst case intercept and batch:
  #   RL Batch Intercept
  # 1 98    b5    100.82
  #
  # Estimated shelf lives for the dics model:
  #   SL RL    wisle     osle
  # 1 95 98 11.40993 23.60194
  #
  # Abbreviations:
  #   ARGPM: Australian Regulatory Guidelines for Prescription Medicines;
  #   ICH: International Council for Harmonisation;
  #   osle: Ordinary shelf life estimation (i.e. following the ICH guidance);
  #   RL: Release Limit;
  #   SL: Specification Limit;
  #   wisle: What-if (approach for) shelf life estimation (see ARGPM guidance).

  res3
  # Expected output of print(res3)
  # Summary of shelf life estimation following the ARGPM
  #   guidance "Stability testing for prescription medicines"
  #
  # The best model accepted at a significance level of 0.25 has
  #  Different intercepts and Different slopes (acronym: dids).
  #
  # Worst case intercept and batch:
  #   RL Batch Intercept
  # 1 98    b8  101.2594
  #
  # Estimated shelf lives for the dids model (for information, the results of
  #   the model fitted with pooled mean square error (pmse) are also shown:
  #   SL RL    wisle wisle (pmse)     osle osle (pmse)
  # 1 95 98 7.619661     7.483223 15.96453    15.72348
  #
  # Abbreviations:
  #   ARGPM: Australian Regulatory Guidelines for Prescription Medicines;
  #   ICH: International Council for Harmonisation;
  #   osle: Ordinary shelf life estimation (i.e. following the ICH guidance);
  #   pmse: Pooled mean square error;
  #   RL: Release Limit;
  #   SL: Specification Limit;
  #   wisle: What-if (approach for) shelf life estimation (see ARGPM guidance).
}