PK Parameters

Using AutoPilot Toolkit, the administrator can select which output (tables, graphs, and appendices) is available for selection in the Automation and Comparison interfaces. In addition, an administrator can filter which PK parameters are available and provide defaults for each table, graph, or text type if they are displayed. “PK automation parameters” presents the full list of PK parameters that administrators can include in the PK tables and graphs from PK Automation projects. “PK comparison parameters” presents the PK parameters that are included in the output from PK Comparison projects.

PK automation parameters

The following table lists the available PK parameters that can be selected for output from automation projects and their treatment in the default output, including the tables PKParameter_A, PKParame­ter_B, Intext_PK_Parameter_I, Urine_PK_Parameter, Urine_Intext_PK_Parameter, PK_Ratios, Urine_PK_Ratios, PK_Stats, Urine_PK_Stats, and Lambda_Z. The list of available parameters varies by NCA model and whether the study contains single-dose (SD) or multiple-dose (MD) data.

Note:For the NCA Model 220, Lambda Z values calculated in Phoenix may differ slightly from results calculated using WinNonlin version 5.x and earlier due to the default setting for the slope being changed from Time Ranges to Best Fit.

Definitions for terms appearing in the table:

WNL Name: Name (column header) provided by NCA model output.

Def Disp Name: Default name displayed in the final output (tables, graphs, and text).

Mod: Parameter is available for a specific NCA Model (e.g., 200 Ext) and regimen (Single-Dose (1D) or Multiple-Dose (MD)).

Def Table: Parameter displays in a specific table by default (LZ = Lambda Z).

Def Graph: Parameter is used for the creation of PK parameter graphs by default.

Ratios/Stats: Parameter displays in the PK Ratios and PK Stats tables by default.

Div/Sub: Parameter is set to show differences in the PK Ratios table based on subtraction (e.g., Trt 2 – Trt 1) or division (Trt 2/Trt 1).

Def Precision: Default precision regarding the type (significant figures or decimal places) and value (e.g., 0) to display in tables.

Normalization: If parameter can have normalization applied to it.

Def Summary / Error: Default summary (e.g. mean) and error term (e.g., SD) per PK parameter for graphs.

Cfg: Default values are configurable in the Administrator Module.

WNL Name
[Def Display] (Cfg)

Mod 200 (Ext)

Mod 201
(IV bolus)

Mod 202
(IV infusion)

Mod 210–212
(urine)

Def Table (Cfg)

Def Graph (Cfg)

Ratio/Stats (Cfg)

Div/Sub

Def Precision
Type/Value (Cfg)

Normalization

Def Summary
/ Error (Cfg)

 

1D

MD

1D

MD

1D

MD

1D
MD

 

 

 

 

 

 

 

Accumulation_Index
[Accumulation]

 

X

 

X

 

X

 

N

N

N

S

dec/0

N

Mean/SD

Amount_Recovered
[Ae]

 

 

 

 

 

 

X

Urine Intext

Y

Y

D

sig/3

Y

Mean/SD

AUC_%Back_Ext_obs
[AUC % Back Extrap]

 

 

X

X

 

 

 

N

N

N

S

dec/0

N

Mean/SD

AUC_%Back_Ext_pred
[AUC % Back Extrap]

 

 

X

X

 

 

 

N

N

N

S

dec/0

N

Mean/SD

AUC_%Extrap_obs
[AUC % Extrap]

X

X

X

X

X

X

 

PKA

N

N

S

dec/0

N

Mean/SD

AUC_%Extrap_pred
[AUC % Extrap]

X

X

X

X

X

X

 

N

N

N

S

dec/0

N

Mean/SD

AUC_TAU
[AUCt]

 

X

 

X

 

X

 

PKA, Intext

Y

Y

D

sig/3

Y

Mean/SD

AUCall
[AUCall]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

AUCINF_D_obs
[AUC¥/D]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

AUCINF_D_pred
[AUC¥/D]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

AUCINF_obs
[AUC¥]

X

X

X

X

X

X

 

PKA, Intext

Y

Y

D

sig/3

Y

Mean/SD

AUCINF_pred
[AUC¥]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

AUClast
[AUClast]

X

X

X

X

X

X

 

PKA, Intext

Y

Y

D

sig/3

Y

Mean/SD

AUMC_%Extrap_obs
[AUMC % Extrap]

X

 

X

 

X

 

 

N

N

N

S

dec/0

N

Mean/SD

AUMC_%Extrap_pred
[AUMC % Extrap]

X

 

X

 

X

 

 

N

N

N

S

dec/0

N

Mean/SD

AUMC_TAU
[AUMCt]

 

X

 

X

 

X

 

N

N

N

D

sig/3

Y

Mean/SD

AUMCINF_obs
[AUMC¥]

X

 

X

 

X

 

 

N

N

N

D

sig/3

Y

Mean/SD

AUMCINF_pred
[AUMC¥]

X

 

X

 

X

 

 

N

N

N

D

sig/3

Y

Mean/SD

AUMClast
[AUMClast]

X

 

X

 

X

 

 

N

N

N

D

sig/3

Y

Mean/SD

AURC_%Extrap_obs
[AURC % Extrap]

 

 

 

 

 

 

X

N

N

N

S

dec/0

N

Mean/SD

AURC_%Extrap_pred
[AURC % Extrap]

 

 

 

 

 

 

X

N

N

N

S

dec/0

N

Med/Min­Max
Mean/SD

AURC_all
[AURCall]

 

 

 

 

 

 

X

N

N

N

D

sig/3

Y

Mean/SD

AURC_INF_obs
[AURC¥]

 

 

 

 

 

 

X

N

N

N

D

sig/3

Y

Mean/SD

AURC_INF_pred
[AURC¥]

 

 

 

 

 

 

X

N

N

N

D

sig/3

Y

NA

AURC(x-y)
[AURCa]

 

 

 

 

 

 

X

N

N

N

D

sig/3

Y

NA

AURClast
[AURClast]

 

 

 

 

 

 

X

N

N

N

D

sig/3

Y

Mean/SD

C0
[C0]

 

 

X

X

 

 

 

N

N

N

D

sig/3

Y

Mean/SD

Cavg
[Cavg]

 

X

 

X

 

X

 

PKB

Y

N

D

sig/3

Y

Mean/SD

Cl_F_obs
[CL/F]

X

 

 

 

 

 

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Cl_F_pred
[CL/F]

X

 

 

 

 

 

 

N

N

N

D

sig/3

Y

Mean/SD

Cl_obs
[CL]

 

 

X

 

X

 

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Cl_pred
[CL]

 

 

X

 

X

 

 

N

N

N

D

sig/3

Y

Mean/SD

Clast
[Clast]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

CLss
[CLss]

 

 

 

X

 

X

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

CLss_F
[CLss/F]

 

X

 

 

 

 

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Cmax
[Cmax]

X

X

X

X

X

X

 

PKA, Intext

Y

Y

D

sig/3

Y

Mean/SD

Cmax_D
[Cmax/Dose]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

Cmin
[Cmin]

 

X

 

X

 

X

 

N

N

N

D

sig/3

Y

Mean/SD

Corr_XY
[Correlation]

X

X

X

X

X

X

 

N

N

N

S

sig/3

N

Med/Min­Max

Fluctuation%
[Fluctuation %]

 

X

 

X

 

X

 

PKB, Intext

Y

N

S

dec/0

N

Mean/SD

HL_Lambda_z
[t1/2]

X

X

X

X

X

X

 

PKB, Intext

Y

N

D

dec/2

Y

Mean/SD

Lambda_z
[lz]

X

X

X

X

X

X

 

LZ

Y

N

D

sig/3

N

Mean/SD

Lambda_z_lower
[lz Lower]

X

X

X

X

X

X

 

LZ

N

N

S

dec/2

N

Med/Min­Max

Lambda_z_upper
[lz Upper]

X

X

X

X

X

X

 

LZ

N

N

S

dec/2

N

Med/Min­Max

Max_Rate
[Max Rate]

 

 

 

 

 

 

X

N

N

N

S

sig/3

Y

Med/Min­Max

Mid_Pt_last
[Midpoint]

 

 

 

 

 

 

X

N

N

N

S

dec/2

N

Med/Min­Max

MRTINF_obs
[MRT¥]

X

X

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

MRTINF_pred
[MRT¥]

X

X

X

X

X

X

 

N

N

N

 

sig/3

Y

Mean/SD

MRTlast
[MRTlast]

X

 

X

 

X

 

 

N

N

N

D

sig/3

Y

Mean/SD

No_points_lambda_z
[Number of Points]

X

X

X

X

X

X

 

LZ

N

N

S

dec/0

N

Med/Min­Max

Partial_Area
[AUCa]

X

X

X

X

X

X

 

PKB

Y

N

D

sig/3

Y

Mean/SD

Percent_Recovered
[fe]

 

 

 

 

 

 

X

Urine

Intext

Y

Y

S

dec/0

Y

Mean/SD

Rate_last
[Last Rate]

 

 

 

 

 

 

X

N

N

N

S

sig/3

Y

Med/Min­Max

Rsq
[R2]

X

X

X

X

X

X

 

N

N

N

S

sig/3

N

Med/Min­Max

Rsq_adjusted
[R2 Adjusted]

X

X

X

X

X

X

 

X

N

N

S

sig/3

N

Med/Min­Max

Tlag
[Tlag]

X

X

 

 

 

 

 

PKB

N

N

S

dec/2

N

Med/Min­Max

Tlast
[Tlast]

X

X

X

X

X

X

 

N

N

N

S

dec/2

N

Med/Min­Max

Tmax
[Tmax]

X

X

X

X

X

X

 

PKA, Intext

Y

N

S

dec/2

N

Med/Min­Max

Tmax_Rate
[Tmax Rate]

 

 

 

 

 

 

X

N

N

N

S

dec/2

N

Med/Min­Max

Tmin
[Tmin]

 

X

 

X

 

X

 

N

N

N

S

dec/2

N

Med/Min­Max

Vol_UR
[Volume]

 

 

 

 

 

 

X

N

N

N

D

dec/0

Y

Mean/SD

Vss_obs
[Vss]

 

 

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

Vss_pred
[Vss]

 

 

X

X

X

X

 

N

N

N

D

sig/3

Y

Mean/SD

Vss/F_obs
[Vss/F]

X

X

 

 

 

 

 

N

N

N

D

sig/3

Y

NA

Vss/F_pred
[Vss/F]

X

X

 

 

 

 

 

N

N

N

D

sig/3

Y

NA

Vz
[Vz]

 

 

 

X

 

X

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Vz_F
[Vz/F]

 

X

 

 

 

 

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Vz_F_obs
[Vz/F]

X

 

 

 

 

 

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Vz_F_pred
[Vz/F]

X

 

 

 

 

 

 

N

N

N

D

sig/3

Y

Mean/SD

Vz_obs
[Vz]

 

 

X

 

X

 

 

PKB, Intext

Y

N

D

sig/3

Y

Mean/SD

Vz_pred
[Vz]

 

 

X

 

X

 

 

N

N

N

D

sig/3

Y

Mean/SD

aThe display name is amended by the time period for the AUC calculation, for example, AUC0-24.

PK comparison parameters

PK Comparison projects calculate the following additional PK parameters, which the user can select to include for a given comparison run. This includes analyte, accumulation, absolute bioavailability, and renal clearance comparisons.

(In the following table “Accum” = Accumulation, “AbBio” = Absolute Bioavailability, “RenCl” = Renal Clearance.)

PK Parameter

Equation

Precision Type
/Default

Comparison Type

Plasma

Trough

Accum

AbBio

RenCl

CLr

Ae(URN)/AUClast

Sig/3

 

 

 

 

X

DoseExt

NA

Dec/0

 

 

 

X

X

DoseIV

NA

Dec/0

 

 

 

X

X

Fabs

AUCinf(PO)*Dose(IV)/AUCnf(IV)*Dose(PO)*100

Dec/0

 

 

 

X

X

LI

AUCtau(MD)/AUCinf(SD)

Dec/3

 

 

X

 

 

RAa 

AUCtau(MD)/AUCtau(SD)

Dec/3

 

 

X

 

 

aRA is calculated from the equation RA=AUCtau(MD)/AUCtau(SD). Since Phoenix does not calcu­late AUCtau for SD, the user needs to create a Partial AUC for the SD model that is equal to the in­terval of the tau. When RA is calculated, AutoPilot Toolkit checks that the parameter Tlast for MD is the same as the interval for the Partial Area set up in the SD model (e.g., tlast=AUC Partial Inter­val). If these are the same, RA is calculated using the above equation. If these values do not match, RA is calculated using the equation, RA=AUCtau (MD)/AUClast (SD).

Last modified date:7/9/20
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