{
  "label": "Same-author re-derivation by a second method; not independent double programming",
  "tool": "diffdf 1.1.2",
  "checks": 40,
  "pass": 40,
  "fail": 0,
  "values_compared": 5100,
  "ledger": [
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "CMAX",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "TMAX",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "TLST",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "CLST",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "AUCLST",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "AUCIFO",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "AUCPEO",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "LAMZHL",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "LAMZ",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "LAMZNPT",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "R2ADJ",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "LAMZLL",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1",
      "item": "NCA parameters per profile",
      "variable": "LAMZUL",
      "primary": "PKNCA 0.12.1 pk.nca()",
      "qc": "NonCompart 0.8.4 tblNCA(), plus the zero-segment trapezoid in base R",
      "n_compared": 79,
      "tolerance": 1e-09,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q1b",
      "item": "NCA parameter rules: values flagged per profile",
      "variable": "AUCIFO_EXCL",
      "primary": "PKNCA exclude() (01_nca.R)",
      "qc": "base-R rule on the NonCompart values",
      "n_compared": 79,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": null,
      "status": "pass"
    },
    {
      "id": "Q1b",
      "item": "NCA parameter rules: values flagged per profile",
      "variable": "LAMZ_EXCL",
      "primary": "PKNCA exclude() (01_nca.R)",
      "qc": "base-R rule on the NonCompart values",
      "n_compared": 79,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": null,
      "status": "pass"
    },
    {
      "id": "Q2",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "ratio",
      "primary": "lm() GLM (02_be.R)",
      "qc": "two-sample t-test on half period differences (closed form)",
      "n_compared": 3,
      "tolerance": 1e-10,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q2",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "lower",
      "primary": "lm() GLM (02_be.R)",
      "qc": "two-sample t-test on half period differences (closed form)",
      "n_compared": 3,
      "tolerance": 1e-10,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q2",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "upper",
      "primary": "lm() GLM (02_be.R)",
      "qc": "two-sample t-test on half period differences (closed form)",
      "n_compared": 3,
      "tolerance": 1e-10,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q2",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "cv_within",
      "primary": "lm() GLM (02_be.R)",
      "qc": "two-sample t-test on half period differences (closed form)",
      "n_compared": 3,
      "tolerance": 1e-10,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q2",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "df",
      "primary": "lm() GLM (02_be.R)",
      "qc": "two-sample t-test on half period differences (closed form)",
      "n_compared": 3,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q3",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "ratio",
      "primary": "lm() GLM (02_be.R)",
      "qc": "nlme::lme() REML, random participant",
      "n_compared": 3,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 1e-10,
      "status": "pass"
    },
    {
      "id": "Q3",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "lower",
      "primary": "lm() GLM (02_be.R)",
      "qc": "nlme::lme() REML, random participant",
      "n_compared": 3,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 6.1e-10,
      "status": "pass"
    },
    {
      "id": "Q3",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "upper",
      "primary": "lm() GLM (02_be.R)",
      "qc": "nlme::lme() REML, random participant",
      "n_compared": 3,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 6.9e-10,
      "status": "pass"
    },
    {
      "id": "Q3",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "cv_within",
      "primary": "lm() GLM (02_be.R)",
      "qc": "nlme::lme() REML, random participant",
      "n_compared": 3,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 1.6e-07,
      "status": "pass"
    },
    {
      "id": "Q3",
      "item": "BE ratio, 90% CI and within-participant CV",
      "variable": "df",
      "primary": "lm() GLM (02_be.R)",
      "qc": "nlme::lme() REML, random participant",
      "n_compared": 3,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q4",
      "item": "ADPC relative times",
      "variable": "NFRLT",
      "primary": "admiral 1.5.0 ad_adpc.R pattern",
      "qc": "base-R difftime() on PCDTC and EXSTDTC",
      "n_compared": 1185,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q4",
      "item": "ADPC relative times",
      "variable": "ARRLT",
      "primary": "admiral 1.5.0 ad_adpc.R pattern",
      "qc": "base-R difftime() on PCDTC and EXSTDTC",
      "n_compared": 1185,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 3.3e-09,
      "status": "pass"
    },
    {
      "id": "Q4",
      "item": "ADPC relative times",
      "variable": "AFRLT",
      "primary": "admiral 1.5.0 ad_adpc.R pattern",
      "qc": "base-R difftime() on PCDTC and EXSTDTC",
      "n_compared": 1185,
      "tolerance": 1e-06,
      "mismatches": 0,
      "max_abs_diff": 3.3e-08,
      "status": "pass"
    },
    {
      "id": "Q5",
      "item": "ADSL population flags",
      "variable": "SAFFL",
      "primary": "admiral ADSL plus 05_adpp.R rules",
      "qc": "base R on DM, EX, PC, AE and PP",
      "n_compared": 40,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": null,
      "status": "pass"
    },
    {
      "id": "Q5",
      "item": "ADSL population flags",
      "variable": "PKCFL",
      "primary": "admiral ADSL plus 05_adpp.R rules",
      "qc": "base R on DM, EX, PC, AE and PP",
      "n_compared": 40,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": null,
      "status": "pass"
    },
    {
      "id": "Q5",
      "item": "ADSL population flags",
      "variable": "PKPFL",
      "primary": "admiral ADSL plus 05_adpp.R rules",
      "qc": "base R on DM, EX, PC, AE and PP",
      "n_compared": 40,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": null,
      "status": "pass"
    },
    {
      "id": "Q5",
      "item": "ADSL population flags",
      "variable": "BEFL",
      "primary": "admiral ADSL plus 05_adpp.R rules",
      "qc": "base R on DM, EX, PC, AE and PP",
      "n_compared": 40,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": null,
      "status": "pass"
    },
    {
      "id": "Q6",
      "item": "Table 14.3.1.1 displayed counts",
      "variable": "N",
      "primary": "rtables/tern table cells",
      "qc": "base-R count on AE and EX",
      "n_compared": 2,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q6",
      "item": "Table 14.3.1.1 displayed counts",
      "variable": "any",
      "primary": "rtables/tern table cells",
      "qc": "base-R count on AE and EX",
      "n_compared": 2,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q6",
      "item": "Table 14.3.1.1 displayed counts",
      "variable": "events",
      "primary": "rtables/tern table cells",
      "qc": "base-R count on AE and EX",
      "n_compared": 2,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q6",
      "item": "Table 14.3.1.1 displayed counts",
      "variable": "related",
      "primary": "rtables/tern table cells",
      "qc": "base-R count on AE and EX",
      "n_compared": 2,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q6",
      "item": "Table 14.3.1.1 displayed counts",
      "variable": "severe",
      "primary": "rtables/tern table cells",
      "qc": "base-R count on AE and EX",
      "n_compared": 2,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q6",
      "item": "Table 14.3.1.1 displayed counts",
      "variable": "serious",
      "primary": "rtables/tern table cells",
      "qc": "base-R count on AE and EX",
      "n_compared": 2,
      "tolerance": 0,
      "mismatches": 0,
      "max_abs_diff": 0,
      "status": "pass"
    },
    {
      "id": "Q7",
      "item": "Control: planted 0.1% change in one AUC(0-t); pass = exactly 1 mismatch found",
      "variable": "AUCLST",
      "primary": "PKNCA results",
      "qc": "the same results with one value changed",
      "n_compared": 79,
      "tolerance": 1e-06,
      "mismatches": 1,
      "max_abs_diff": 1.4,
      "status": "pass"
    },
    {
      "id": "Q8",
      "item": "Control: NonCompart AUC(0-t) without the zero-segment trapezoid; pass = mismatches in exactly the 1 profile(s) with a BLQ value between quantifiable samples",
      "variable": "AUCLST",
      "primary": "PKNCA results",
      "qc": "NonCompart tblNCA() as it comes",
      "n_compared": 79,
      "tolerance": 1e-06,
      "mismatches": 1,
      "max_abs_diff": 69,
      "status": "pass"
    }
  ]
}