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  •  Fill in results and units for rows 6 and 7
  •  Fill in PKCON 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)
  •  Review suppPP dataset makes sure it looks ok

The example below shows how to represent various PK analysis parameters at multiple dose, steady state condition.

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Namepp


Rowcaps


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 pre-corrdinating "Ratio AUC of Drug Parent over Drug Metabolite 1" all into the PPTEST, 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.



Dataset2
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hi2row 7
hi1row 6
hi2styleaquarows 6, 7
tableidPP EXAMPLE 1


PPMETHODCALCULATIONCALCULATION
RowSTUDYIDDOMAINUSUBJIDPPSEQPPRFIDPPTESTCDPPTESTPPCATPPSCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSPECPPANMETHPPFASTPPNOMDYPPRFTDTC
1ABC-123PP123-10011B2222

AUCINT

AUC from T1 to T2DRUG PARENTNCA154.1h*ng/L154.1154.1h*ng/LPLASMA
Y12001-02-01T12:00
2ABC-123PP123-10012B2222

AUCINT

AUC from T1 to T2DRUG METABOLITE 1NCA144.5h*ng/L144.5144.5h*ng/LPLASMA
Y12001-02-01T12:00
3ABC-123PP123-10013B2222AUCINTAUC from T1 to T2DRUG METABOLITE 2NCA294.7h*ng/L294.7294.7h*ng/LPLASMACALCULATION
Y12001-02-01T12:00
4ABC-123PP123-10014B2222RAAUCRatio AUC
NCA1.07
1.071.07
PLASMACALCULATIONDRUG METABOLITE 1 (PPSEQ 2) TO DRUG PARENT (PPSEQ 1)Y12001-02-01T12:00
5ABC-123PP123-10015B2222RAAUCRatio AUC
NCA0.52
0.520.52
PLASMACALCULATIONDRUG METABOLITE 2 (PPSEQ 3) TO DRUG PARENT (PPSEQ 1)Y12001-02-01T12:00
6ABC-123PP123-10011B2222AUCIFOAUC Infinity ObsDRUG PARENTNCA?????PLASMACALCULATIONLIN-LOG TRAPEZOIDAL METHODY1

2001-02-01T12:00

7ABC-123PP123-10012B2222AUCIFPAUC Infinity PredDRUG PARENTNCA?????PLASMACALCULATIONLIN-LOG TRAPEZOIDAL METHODY1

2001-02-01T12:00



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