- Fill in results and units for rows 6 and 7
- Fill in PKCOND values for rows 6 and 7
- ANMETH is a "record qualifier" according to Model 2.0 so technically we don't need to add the METHOD variable into PP. There would only be one valid value of PPMETHOD anyway = CALCULATION. (Confirm with Fred)
- Rows 4-5 can the values in PPANMETH also in PPCAT? (Because PPCAT is blank)
- Should ANMETH be only used for named formulas like how LB is using it?
- Remove PPMETHOD from PP specification table if decided not needed.
- Review suppPP dataset makes sure it looks ok
- Do people use PC/PP domain for compartmental analysis data as well? For CT we don’t control none-NCA values, but that’s CT ONLY, on the domain level, do people use PC/PP for None-NCA data anyway? The new term request from GSK asked for a controlled codelist for PKANMETH but the requested value is actually for compartmental analysis – this suggests to me that folks are using PC/PP for compartmental analysis data. Currently the SDTMIG does not explicitly state that users should only represent NCA data in PC/PP. Better understanding this would help to decide whether we should add ANMETH into PP.
The example below shows how to represent various PK analysis parameters at multiple dose, steady state condition.
| 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 Metabolite 1 to Drug Parent. Instead of pre-corrdinating "Ratio AUC of Drug Metabolite 1 to Drug Parent" all into the PPTEST, PPANMETH is used to describe the numerator (Drug Metabolite 1) and the denominator (Drug Parent) 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 Metabolite 2 to Drug Metabolite 1. Note the PPTEST is Ratio AUC, whereas DRUG METABOLITE 2 TO METABOLITE 1 is in PPANMETH. | | 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 | PPANMETH | PPFAST | PPNOMDY | PPRFTDTC |
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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 |
| Y | 1 | 2001-02-01T12:00 | | 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 |
| Y | 1 | 2001-02-01T12:00 | | 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 |
| Y | 1 | 2001-02-01T12:00 | | 4 | ABC-123 | PP | 123-1001 | 4 | B2222 | RAAUC | Ratio AUC | DRUG METABOLITE 1 | NCA | 1.07 |
| 1.07 | 1.07 |
| PLASMA | DRUG METABOLITE 1 TO DRUG PARENT | Y | 1 | 2001-02-01T12:00 | | 5 | ABC-123 | PP | 123-1001 | 5 | B2222 | RAAUC | Ratio AUC | DRUG METABOLITE 2 | NCA | 0.52 |
| 0.52 | 0.52 |
| PLASMA | DRUG METABOLITE 2 TO METABOLITE 1 | Y | 1 | 2001-02-01T12:00 | | 6 | ABC-123 | PP | 123-1001 | 1 | B2222 | AUCIFO | AUC Infinity Obs | DRUG PARENT | NCA | 520 | h*ng/L | 520 | 520 | h*ng/L | PLASMA | 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 | 510 | h*ng/L | 510 | 510 | h*ng/L | PLASMA | 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 Analysis was performed.
| 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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| 6 | ABC-123 | PP | 123-1001 | PPSEQ | 6 | PKCOND | Condition of PK Analysis | MULTIPLE DOSE, STEADY STATE | eDT |
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| 7 | ABC-123 | PP | 123-1001 | PPSEQ | 7 | PKCOND | Condition of PK Analysis | SINGLE DOSE | eDT |
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