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| Rows 1-3: | Show the "AUC from T1 to T2" measurements for Drug Parent (Row 1), Drug Metabolite 1 (Row 2) and Drug Metabolite 2 (Row 3). | | Row 4: | Shows the "Ratio AUC" measurement of Drug Parent to Drug Metabolite 1. Instead of creating pre-corrdinating "Ratio AUC of Drug Parent over Drug Metabolite 1" in all into the PPTEST, the non-standard variable "NSV1 Name TBD" PPANMETH is used to describe the numerator (Drug Parent, PPSEQ 1) and the denominator (Drug Metabolite 1, PPSEQ2) values that contribute to the Ratio AUC calculation in PPTEST. This post-coordination approach liberates the PPTEST variable from having to house hyper-specific, pre-coordinated PK parameter values. | | Row 5: | Shows the "Ratio AUC" measurement of Drug Parent to Drug Metabolite 2. Instead of pre-corrdinating "Ratio AUC of Drug Parent over Drug Metabolite 2" all into the PPTEST, PPANMETH is used to describe the numerator (Drug Parent, PPSEQ 1) and the denominator (Drug Metabolite 2, PPSEQ3) values that contribute to the Ratio AUC calculation in PPTEST. This post-coordination approach liberates the PPTEST variable from having to house hyper-specific, pre-coordinated PK parameter values. | | Rows 6-7: | Show AUC Infinity Obs and AUC Infinity Pred for the DRUG PARENT. Both are calculated using the LIN-LOG TRAPEZOIDAL METHOD which is in PPANMETH. |
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| Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPRFID | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSPEC | PPMETHOD | PPANMETH | PPFAST | PPNOMDY | PPRFTDTC | PKCOND |
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| 1 | ABC-123 | PP | 123-1001 | 1 | B2222 | AUCINT | AUC from T1 to T2 | DRUG PARENT | NCA | 154.1 | h*ng/L | 154.1 | 154.1 | h*ng/L | PLASMA | CALCULATION |
| Y | 1 | 2001-02-01T12:00 | MULTIPLE DOSE, STEADY STATE | | 2 | ABC-123 | PP | 123-1001 | 2 | B2222 | AUCINT | AUC from T1 to T2 | DRUG METABOLITE 1 | NCA | 144.5 | h*ng/L | 144.5 | 144.5 | h*ng/L | PLASMA | CALCULATION |
| Y | 1 | 2001-02-01T12:00 | MULTIPLE DOSE, STEADY STATE | | 3 | ABC-123 | PP | 123-1001 | 3 | B2222 | AUCINT | AUC from T1 to T2 | DRUG METABOLITE 2 | NCA | 294.7 | h*ng/L | 294.7 | 294.7 | h*ng/L | PLASMA | CALCULATION |
| Y | 1 | 2001-02-01T12:00 | MULTIPLE DOSE, STEADY STATE | | 4 | ABC-123 | PP | 123-1001 | 4 | B2222 | RAAUC | Ratio AUC |
| NCA | 1.07 |
| 1.07 | 1.07 |
| PLASMA | CALCULATION | DRUG METABOLITE 1 (PPSEQ 2) TO DRUG PARENT (PPSEQ 1) | Y | 1 | 2001-02-01T12:00 | MULTIPLE DOSE, STEADY STATE | | 5 | ABC-123 | PP | 123-1001 | 5 | B2222 | RAAUC | Ratio AUC |
| NCA | 0.52 |
| 0.52 | 0.52 |
| PLASMA | CALCULATION | DRUG METABOLITE 2 (PPSEQ 3) TO DRUG PARENT (PPSEQ 1) | Y | 1 | 2001-02-01T12:00 | MULTIPLE DOSE, STEADY STATE | | 6 | ABC-123 | PP | 123-1001 | 1 | B2222 | AUCIFO | AUC Infinity Obs | DRUG PARENT | NCA | ? | ? | ? | ? | ? | PLASMA | CALCULATION | LIN-LOG TRAPEZOIDAL METHOD | Y | 1 | 2001-02-01T12:00
| | 7 | ABC-123 | PP | 123-1001 | 2 | B2222 | AUCIFP | AUC Infinity Pred | DRUG PARENT | NCA | ? | ? | ? | ? | ? | PLASMA | CALCULATION | LIN-LOG TRAPEZOIDAL METHOD | Y | 1 | 2001-02-01T12:00
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The SUPPPP dataset example shows the specific condition under which the PK Analyais Analysis was performed.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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| 1 | ABC-123 | PP | 123-1001 | PPSEQ | 1 | PKCOND | Condition of PK Analysis | MULTIPLE DOSE, STEADY STATE | eDT |
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| 2 | ABC-123 | PP | 123-1001 | PPSEQ | 2 | PKCOND | Condition of PK Analysis | MULTIPLE DOSE, STEADY STATE | eDT |
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| 3 | ABC-123 | PP | 123-1001 | PPSEQ | 3 | PKCOND | Condition of PK Analysis | MULTIPLE DOSE, STEADY STATE | eDT |
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| 4 | ABC-123 | PP | 123-1001 | PPSEQ | 4 | PKCOND | Condition of PK Analysis | MULTIPLE DOSE, STEADY STATE | eDT |
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| 5 | ABC-123 | PP | 123-1001 | PPSEQ | 5 | PKCOND | Condition of PK Analysis | MULTIPLE DOSE, STEADY STATE | eDT |
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