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:

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

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

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

Default Table: Parameter displays in a specific table by default.

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

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

Divide or Subtract: 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).

Default 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.

Default Summary and 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.

WinNonlin Name

Default Display
Name (Cfg)

Model 200 (Ext)

Model 201
(IV bolus)

Model 202
(IV infusion)

Model 210–212
(urine)

Default Table (Cfg)

Default Graph (Cfg)

Ratio & Stats (Cfg)

Divide or Subtract

Default Precision
(Cfg)

Normalization

Default Summary
& Error (Cfg)

 

 

SD

MD

SD

MD

SD

MD

SD MD

 

 

 

 

Type/Value

 

 

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

 

PK A

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

 

PK A, 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

 

PK A, 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

 

PK A, 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, Min/Max, 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

 

PK B

Y

N

D

sig/3

Y

Mean, SD

Cl_F_obs

CL/F

X

 

 

 

 

 

 

PK B, 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

 

 

PK B, 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

 

PK B, Intext

Y

N

D

sig/3

Y

Mean, SD

CLss_F

CLss/F

 

X

 

 

 

 

 

PK B, Intext

Y

N

D

sig/3

Y

Mean, SD

Cmax

Cmax

X

X

X

X

X

X

 

PK A, 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, Min/Max

Fluctuation%

Fluctuation %

 

X

 

X

 

X

 

PK B, Intext

Y

N

S

dec/0

N

Mean, SD

HL_Lambda_z

t1/2 

X

X

X

X

X

X

 

PK B, Intext

Y

N

D

dec/2

Y

Mean, SD

Lambda_z

lz 

X

X

X

X

X

X

 

Lambda_Z

Y

N

D

sig/3

N

Mean, SD

Lambda_z_lower

lz Lower 

X

X

X

X

X

X

 

Lambda_Z

N

N

S

dec/2

N

Med, Min/Max

Lambda_z_upper

lz Upper 

X

X

X

X

X

X

 

Lambda_Z

N

N

S

dec/2

N

Med, Min/Max

Max_Rate

Max Rate

 

 

 

 

 

 

X

N

N

N

S

sig/3

Y

Med, Min/Max

Mid_Pt_last

Midpoint

 

 

 

 

 

 

X

N

N

N

S

dec/2

N

Med, Min/Max

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

 

Lambda_Z

N

N

S

dec/0

N

Med, Min/Max

Partial_Area

AUCa

X

X

X

X

X

X

 

PK B

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, Min/Max

Rsq

R2 

X

X

X

X

X

X

 

N

N

N

S

sig/3

N

Med, Min/Max

Rsq_adjusted

R2 Adjusted

X

X

X

X

X

X

 

X

N

N

S

sig/3

N

Med, Min/Max

Tlag

Tlag 

X

X

 

 

 

 

 

PK B

N

N

S

dec/2

N

Med, Min/Max

Tlast

Tlast 

X

X

X

X

X

X

 

N

N

N

S

dec/2

N

Med, Min/Max

Tmax

Tmax 

X

X

X

X

X

X

 

PK A, Intext

Y

N

S

dec/2

N

Med

Min & Max

Tmax_Rate

Tmax Rate

 

 

 

 

 

 

X

N

N

N

S

dec/2

N

Med, Min/Max

Tmin

Tmin 

 

X

 

X

 

X

 

N

N

N

S

dec/2

N

Med, Min/Max

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

 

PK B, Intext

Y

N

D

sig/3

Y

Mean, SD

Vz_F

Vz/F

 

X

 

 

 

 

 

PK B, Intext

Y

N

D

sig/3

Y

Mean, SD

Vz_F_obs

Vz/F

X

 

 

 

 

 

 

PK B, 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

 

 

PK B, 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.

PK Parameter

Equation

Precision Type/Default

Comparison Type

Plasma

Trough

Accum

Abs Bio

Avail

Renal Cl

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:6/26/19
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