Output

AutoPilot Toolkit produces four types of output:

Phoenix WinNonlin files

Tables as Microsoft Excel files

Graphs as SigmaPlot files and Windows Metafile graphics

Text, which is displayed in Microsoft Word documents.

Additionally, the Phoenix output includes the files produced by an NCA model during model fitting. Refer to the “Administration Module” section to learn how to configure which of the available files are produced.

The available output for both automation and comparison are described in the following sections:

Table output

PK Automation tables

PK Comparison tables

Graph output

PK Automation graphs

PK Comparison graphs

Appendix output

PK Automation appendix output

PK Comparison appendix output

Note:    Subject IDs with many digits (e.g., 100010901) are displayed in exponential format in the output tables.

On Chinese and Japanese (Kanji) operating systems, the multiplication symbol is displayed as an question mark in all output generated from automation and comparison objects

When “mu” or “u” is used for variable units or in treatment descriptions, it is not replaced by the Greek symbol (m) in the generated tables.

Table output

Table output can sometimes be truncated when displayed in Excel. If this happens, drag the right border of the column to resize it.

PK Automation tables

PK Comparison tables

PK Automation tables

Depending on the settings in the Admin Module, AutoPilot Toolkit automation projects can create combinations of the tables listed below. The table following the list summarizes the tables available for each combination of study design and dosing.

Note that for all tables containing summary statistics, the values shown in the output table are not used to calculate summary statistics. Instead, the raw values from the NCA model are used for these calculations.

Table/file names marked with an asterisk have example output tables located in the “Automation Output Examples” section and the associated Phoenix Table Template for each is shown in square brackets.

*Demographics [Table 3]

Subject baseline demographics (age, weight) values for individuals with summary statistics sorted by treatment. Crossover study designs create one table with all subjects included. Parallel study designs create a unique table per treatment.

*Actual_Times [Table 6]

Actual sample times for individuals with summary statistics sorted by treatment.

*Trough_Actual_Times_Trt [Table 6]

Actual sample times (Trough only) for individuals with summary statistics sorted by treatment.

*Actual_Times_Dev [Table 6]

Actual sample time deviations (difference of actual time and nominal time) for individuals sorted by treatment.

*Concentration [Table 6]

Concentration values for individuals with summary statistics sorted by treatment.

*Concentration_Strat-<Var> [Table 6]

Concentration values for individuals with summary statistics sorted by treatment along with user-specified stratification variable.

*Trough_Concentration_Trt [Table 3]

Concentration (Trough only) values for individuals with summary statistics sorted by treatment.

*Trough_Concentration_Strat-<Var>_Trt [Table 3]

Concentration (Trough only) values for individuals with summary statistics sorted by treatment along with user-specified stratification variable.

*Urine_ Amount^a [Table 6]

Urine amount excreted over discrete collection intervals, or over the midpoints of discrete collection intervals, for individuals with summary statistics sorted by treatment.

Urine_Amount_Strat-<Var>^a [Table 6]

Urine amount excreted over discrete collection intervals of summary statistics sorted by treatment along with stratification variable selected in the interface.

*Urine_Cumul_Amount^a [Table 6]

Urine amount excreted over cumulative collection intervals for individuals with summary statistics sorted by treatment.

*Urine_Cumul_Amount_Strat-<Var>^a [Table 6]

Urine amount excreted over cumulative collection intervals for summary statistics sorted by treatment along with user-specified stratification variable.

*Urine_Actual_Times [Table 6]

Actual time intervals for urine collection. Derived from actual time/nominal time.

*Lambda_Z [Table 3]

Individual values for selected regression fits by treatment with summary statistics. If Phoenix cannot create a regression line (for instance, when concentration increases over time), AutoPilot Toolkit cannot generate any table based on regression values like Lambda_Z. To force a regression line, set the start and stop times in Phoenix larger than t_last.

*Cumul_AUC [Table 6]

Individual AUC values by RNT by treatment with summary statistics.

*PK_Parameter_{a-z}^b [Table 3]

PK parameters values for individuals with summary statistics sorted by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications).

*PK_Parameter_{a-z}_Strat-<Var>^b [Table 3]

PK parameters summary statistics sorted by treatment along with stratification variable selected in the interface. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications).

Urine_PK_Parameter^b [Table 3]

Urine PK parameters values for individuals with summary statistics sorted by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications).

Urine_PK_Parameter_Strat-<Var>^b [Table 3]

Urine PK parameters summary statistics sorted by treatment along with user-specified stratification variable. The PK parameters displayed depend upon interface selections (NCA Model selected and output specifications).

*Intext_PK__Parameter_{a-z}^b [Special template]

PK parameter summary statistics values are displayed by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geometric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

*Intext_PK_Parameter_{a-z}_Strat-<Var>^b [Special template]

PK parameter summary statistics values are displayed by treatment along with user-specified stratification variable. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geometric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

Urine_Intext_PK_Parameter_Analyte^b [Special template]

Urine PK parameter summary statistics values are displayed by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geometric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

Urine_Intext_PK_Parameter_Strat-<Var>^b [Special template]

Urine PK parameter summary statistics values are displayed by treatment along with user-specified stratification variable. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geometric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

*PK_Ratios [Table 3]

PK parameter ratio values for individuals with summary statistics sorted by a pair-wise treatment comparison. The table is only produced for a Crossover study type and with interface selections for PK Ratios and Reference.

Urine_PK_Ratios [Table 3]

Urine PK parameter ratio values for individuals with summary statistics sorted by a pair-wise treatment comparison. The table is only produced for a Crossover study type and with interface selections for PK Ratios and Reference.

*PK_Stats (Randomized Crossover, Non-Randomized Crossover, Parallel) [Special template]

Inferential statistics on user-specified subset of PK parameters. Tables are only produced when selecting Calculate Inferential Statistics and a Reference.

Urine_PK_Stats (Randomized Crossover, Non-Randomized Crossover, Parallel) [Special template]

Inferential statistics on a subset of Urine PK parameters are displayed in PK parameter tables. Provides p-value information for all tables. For a Crossover study design, additional values for Statistical Power, GLSM, and Confidence intervals are displayed. Only one table is created for all study designs. Tables are only produced when selecting Calculate Inferential Statistics and a Reference.

Profile_Exclusions [Special template]

Listing of subjects with their profile data collection variables that were excluded using the Automation Exclusion feature. No summary statistics.

^aIf a cumulative amount excreted dataset includes negative time values, then both midpoint and rate are calculated using nominal times instead of the NCA Summary worksheet. This can possibly result in values being different between the tables and the NCA Summary worksheet, and the cumulative value per profile could be different compared to the amount excreted PK Parameter value in the Final Parameters worksheet.

^bA replicated Crossover design creates two sets of table outputs consisting of set one = sorted by Treatment, 'Trt', where the values are the ratio of Period 2/Period 1 for all variables except time parameters (e.g., tmax is subtracted [Period 2 - Period 1]) and set two = sorted by period, 'Per'. By Period tables are created for all table types; tables with a footnote '1' are also created by Trt method above.

PK Automation Tables by Study Design, Dosing, and Matrix 

The following table details which tables are available for each study type, dosing, and matrix. Abbreviations in the table include:

SD: Single-Dose applies to Plasma

MD: Multiple-Dose applies to Plasma

TR:Trough

UR: Urine

PK Comparison tables

For all comparison types that include PK parameters (excluding the Analyte types of Plasma and Urine), the PK parameters that were used in the automation runs in PK Parameter A–F tables and the Intext table become the master list of available PK parameters that can be used in a Comparison project.

For the Analyte comparison types, the list of available PK parameters for the comparison run also come from the PK Parameter A–F and Intext tables but are only the intersection of common parameters used in the automation runs.

Depending on the AutoPilot Toolkit Admin settings, PK Comparison projects can output combinations of the tables listed in the following table. The second table lists tables available for each comparison type.

Table/file names marked with an asterisk (*) have example output tables located in the “Comparison Output Examples” section and the associated Phoenix Table Template for each is shown in square brackets.

*Comparison_Concentration_Ratios [Table 6]

Concentration ratio values for individuals with summary statistics. One table per treatment or period and day (if multiple dose) with the ratios based on analyte (parent vs. metabolite). Limited to Analyte-Plasma comparisons of automation runs using NCA models 200–202.

Comparison_Trough_Concentration_Ratios [Table6]

Trough concentration ratio values for individuals with summary statistics. One table per treatment or period and day (if multiple dose) with the ratios based on analyte (parent vs. metabolite). Limited to Analyte-Plasma comparisons for Trough (no NCA model) automations.

*Comparison_PK_Parameter_{a-z}_Ratios, for Analyte, Day, Abs Bioavail, and CLr^a [Table3]

PK parameter ratio values for individuals with summary statistics. Analyte Comp (Plasma): ratios based on analyte (parent vs. metabolite). Accumulation Comp: ratios based on day (multiple dose (test) vs. ref (SD)). Abs Bioavail Comp: ratios based on treatment (100 mg PO vs. 100 mg IV). Renal CLr Comp: ratios based on matrix (Plasma (test) vs. Ref (Ext)).
Note: In some instances, the table does not display the entire treatment description if table splitting is applied.

*Comparison_Intext_PK_Parameter for Analyte, Day, Abs Bioavail, and CLr^a [Special template]

PK parameter summary statistic values. Analyte Comp (Plasma): separate columns for each analyte. Accumulation Comp: separate columns for each day. Abs Bioavail Comp: separate columns for each treatment. Renal CLr Comp: separate columns for plasma matrix data.

^aThese tables can have all treatments displayed within the same type or one table per treatment depending on the selection made in the Comparison interface (all in same table or separate by table).

Comparison Tables by Type and Matrix 

The following table describes which output tables can be generated by each PK Comparison type, depending on Admin settings and interface selections.

(In the following table “Pl” = Plasma, “Ur” = Urine, “Tr” = Trough, “Acc” = Accumulation, “AbBio” = Absolute Bioavailability, “RenCl” = Renal Clearance.)

Graph output

PK Automation graphs

PK Comparison graphs

Each graph is created as an originating SigmaPlot file (*.jnb), followed by one of the following, depending on the version of SigmaPlot being used:

JPG using SigmaPlot 12.x (*.jpg)

EMF using SigmaPlot 11.x (*.emf)

WMF using SigmaPlot 10.x (*.wmf)

For some graphs (Concentration by Subject, Excretion Rate by Subject, Percent Dose Remaining by Subject, Trough Concentration by Subject, Individual Cumulative Amount Excreted, and Individual Amount Excreted), the individual *.jpg,*.wmf, or *.EMF files are gathered into MS Word documents. Each of these types also generates a single *.jnb file containing all subjects.

For all PK parameter graphs the [PK_Param] part of the filename can be changed by the administrator. The resulting filename can only include allowed characters for the Windows operating system.

With SigmaPlot box/whisker graphs, at least three data points are necessary to show a box graph and at least nine data points are needed for a whisker graph. Also, if none of the x values have more than two data points associated with them, then the graph itself is not created. SigmaPlot automatically calculates the mean, median and confidence interval values. Therefore, these plot types do not make use of the small sample size business rules.

Note:    If X-axis tick-mark labels are too long, they may overlap. This problem can also occur when there are time values that are closely grouped together.

If the first tick mark on X-axes is clipped, edit the.jnb file and set the Start value of the Range for the X-axis to a smaller value. As a result, the first tick mark and the label will move to the left and the whole text will be displayed.

A note about graph legends: On occasion, the text in a graph legend can become misaligned. For example, when a graph involves LOQ lines, the LOQ text displayed in graph legends (LOQ=X ug/mL) is not aligned with the rest of the legend text. The width of the symbols in the legend can be manually adjusted to correctly align the text with the following steps:

Right-click on any text in the legend and select Edit.

In the Edit Text dialog, press Symbol to open the Symbols dialog.

Adjust the width of all symbols and/or lines to an equal width, for example 0.25".

Press OK, then close the Edit Text dialog.

PK Automation graphs

Depending on the settings in the Admin Module, AutoPilot Toolkit automation projects can create combinations of the graphs listed below. The table following the list summarizes the graphs available for each combination of study design and dosing. PK_Parameter graphs are available with normalized or stratified data. Graph file names marked with an asterisk (*) have example output graphs located in the “Automation Output Examples” section.

Time Concentration Graphs — Plasma 

*Conc_by_Subject 

Individual time-concentration plot, one subject per graph. Activate Individual Time Concentration checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Time_Concentration.doc.

*Conc_Trt^a 

Spaghetti individual time-concentration plot, one graph per unique treatment or period. Can have variability data (e.g., mean, median, etc.).

*Conc_Trt_GroupBy-Strat-[Demog]^b 

Spaghetti individual time-concentration plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

*Summary_Conc_Trt^a 

Time-concentration summary, all treatments or periods on one graph.

*Summary_Conc_Trt_GroupBy-Strat-[Demog]^a 

Time-concentration summary, all treatments or periods on one graph with demographic variables in the legend (e.g., Treatment 1 Male, Treatment 1 Female).

Summary_Conc_Strat-[Demog][Value] 

Time-concentration summary, one graph per demographic variable value (e.g., Male) with all treatments or periods in the legend (e.g., Treatment 1, Treatment 2).

Time Concentration Graphs — Urine 

*Excretion_Rate_by_Subject_Lin/Log 

Individual urine excretion rate, one subject per graph. Activate Individual Excretion Rate checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Excretion_Rate.doc.

*Excretion_Rate_Trt_Lin/Log^a 

Spaghetti urine individual excretion rate plot, one graph per unique treatment or period, can have variability data (e.g., mean, median).

Excretion_Rate_Trt_GrouBy-Strat-[Demog]_Lin/Log^a 

Spaghetti individual urine excretion rate plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

*Summary_Excretion_Rate_Lin/Log^a 

Excretion rate summary, all treatments or periods on one graph.

Note: If one or more subjects in a data set have a negative relative actual time value, the mean values are not displayed in the plots when the relative actual end time is used as the X-axis variable. If the default X-axis variable Midpoint Time is used, then the mean values in the table are plotted.

Summary_Excretion_Rate_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Excretion rate summary, all treatments or periods on one graph with demographic variables in the legend (e.g., Treatment 1 Male, Treatment 1 Female).

Summary_Excretion_Rate_Strat-[Demog][Value]_Lin/Log^a 

Excretion rate summary, one graph per demographic variable value (e.g., Male) with all treatments or periods in the legend (e.g., Treatment 1, Treatment 2).

Percent_Dose_Remaining_by_Subject_Lin/Log^a 

Percent dose remaining to be excreted (%) one subject per graph. Activate Individual Percent Excreted checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Percent_Excreted.doc.

Percent_Dose_Remaining_Trt_Lin/Log^a 

Spaghetti percent dose remaining to be excreted individual (%) plot, one graph per unique treatment or period. Can have variability data (e.g., mean, median).

Percent_Dose_Remaining_Trt_GroupBy-Strat_[Demog]_Lin/Log^a 

Spaghetti individual percent dose remaining plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

Summary_Percent_Dose_Remaining_Lin/Log^a 

Percent dose remaining to be excreted summary, all treatments or periods on one graph.

Summary_Percent_Dose_Remaining_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Percent dose remaining summary, all treatments or periods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Percent_Dose_Remaining_Strat-[Demog][Value]_Lin/Log 

Percent dose remaining summary, one graph per demographic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

*Cumulative_Amount_Excreted_by_Subject_Lin/Log 

Individual line plot of the cumulative amount excreted by subject vs. midpoint or end time; linear and logarithmic scaling available. Activate Individual Cumulative Amount Excreted checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Cumulative_Amount_Excreted.doc.

*Cumulative_Amount_Excreted_Trt_Lin/Log 

Spaghetti plot of the cumulative amount excreted by treatment vs. midpoint or end time; linear and logarithmic scaling available.

Note: If one or more subjects in a data set have a negative relative actual time value, the mean values are not displayed in the plots when the relative actual end time is used as the X-axis variable. If the default X-axis variable Midpoint Time is used, then the mean values in the table are plotted.

Cumulative_Amount_Excreted_Trt_GroupBy-Strat_[Demog]_Lin/Log^a 

Spaghetti individual cumulative amount excreted plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

Summary_Cumulative_Amount_Excreted_Lin/Log^a 

Cumulative amount excreted summary, all treatments or periods on one graph.

Summary_Cumulative_Amount_Excreted_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Cumulative amount excreted summary, all treatments or periods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Cumulative_Amount_Excreted_Strat-[Demog][Value]_Lin/Log 

Cumulative amount excreted summary, one graph per demographic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

*Amount_Excreted_by_Subject_Lin/Log 

Individual line plot of amount excreted by subject vs. midpoint or end time; linear and logarithmic scaling available. Activate Individual Amount Excreted checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Amount_Excreted.doc.

Note: In cases where there is more than one value in the Matrix column in the study data, the first Matrix value is the value displayed in the output. This can result in incorrect Y-axis labels for graphs. You may have to remove all rows for the first Matrix value to obtain the correct Y-axis labels.

*Amount_Excreted_Trt_Lin/Log 

Spaghetti plot of amount excreted by treatment vs. midpoint or end time; linear and logarithmic scaling available.

Amount_Excreted_Trt_GroupBy-Strat_[Demog]_Lin/Log^a 

Spaghetti individual amount excreted plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

*Summary_Amount_Excreted_Trt_Lin/Log 

Line plot of the summary amount excreted by treatment vs. midpoint or end time; linear and logarithmic scaling available, as are error bars.

Summary_Amount_Excreted_Lin/Log^a 

Amount excreted summary, all treatments or periods on one graph.

Summary_Amount_Excreted_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Amount excreted summary, all treatments or periods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Amount_Excreted_Strat-[Demog][Value]_Lin/Log 

Amount excreted summary, one graph per demographic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

Time Concentration Graphs — Trough 

Conc_by_Subject_Lin/Log 

Individual trough time-concentration, one subject per graph. Activate Individual Trough Concentration checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Trough_Concentration.doc.

Conc_Trt_Lin/Log^a 

Spaghetti trough individual time-concentration plot, one graph per unique treatment, period. Can have variability data (e.g. mean, median).

Conc_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Spaghetti trough individual time-concentration plot, one graph per unique treatment, period. Can contain variability data, separated by All or demographic variables (e.g. All Mean, Male Mean, Female Mean).

Summary_Conc_Trt_Lin/Log^a 

Trough time-concentration summary, all treatments or periods on one graph.

Summary_Conc_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Trough time-concentration summary, all treatments or periods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Conc_Strat-[Demog][Value]_Lin/Log^a 

Trough time-concentration summary, one graph per demographic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

PK Parameter Graphs — Plasma and Urine 

*[PKParam] 

PK parameter vs. categorical treatment or period.

[PKParam]_Norm-[Demog] 

Normalized PK parameter vs. categorical treatment or period.

*[PKParam]_Trt_GroupBy-Strat-[Demog]^a 

PK parameter stratified by discrete demographic; categorical X-axis is demographic values with one graph per treatment or period.

[PKParam]_Strat-[Demog][Value] 

PK parameter stratified by discrete demographic; categorical X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

[PKParam]_Norm-[Demog]_Trt_GroupBy-Strat-[Demog]^a 

Normalized PK parameter stratified by discrete demographic; categorical X-axis is demographic values with one graph per treatment or period.

[PKParam]_Norm-[Demog]_Strat-[Demog][Value] 

Normalized PK parameter stratified by discrete demographic; categorical X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

*Box_[PKParam] 

Box and whisker plot of PK parameter vs. categorical t

Box_[PKParam]_Norm-[Demog] 

Box and whisker plot of normalized PK parameter vs. categorical treatment or period.

Box_[PKParam]_Trt_GroupBy-Strat-[Demog]^a 

Box and whisker plot of PK parameter stratified by discrete demographic; categorical X-axis is demographic values with one graph per treatment or period.

Box_[PKParam]_Strat_[Demog][Value] 

Box and whisker plot of PK parameter stratified by discrete demographic; categorical X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

Box_[PKParam]_Norm-[Demog]_Trt_GroupBy-Strat-[Demog]^a 

Box and whisker plot of normalized PK parameter stratified by discrete demographic; categorical X-axis is demographic values with one graph per treatment or period.

Box[PKParam]_Norm-[Demog]_Strat-[Demog][Value] 

Box and whisker plot of normalized PK parameter stratified by discrete demographic; categorical X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

*[PKParam]_by-Dose 

PK parameter vs. continuous dose X-variable.

[PKParam]_Norm-[Demog]_vs-Dose 

Normalized PK parameter vs. continuous dose X-variable.

Box_[PKParam]_vs-Dose 

Box and whisker plot of PK parameter vs. continuous dose X-variable.

Box_[PKParam]_Norm-[Demog]_vs-Dose 

Box and whisker plot of normalized PK parameter vs. continuous dose X-variable.

*[PKParam]_ vs-Cont-[Demog] 

PK parameter vs. continuous demographic X-variable; all individual subjects for all treatments or periods are displayed on same graph.

[PKParam]_Norm-[Demog]_vs-Cont-[Demog] 

Normalized PK parameter vs. continuous demographic X-variable; all individual subjects for all treatments or periods are displayed on same graph.

*[PKParam]_ Trt_vs-Cont-[Demog]^a 

PK parameter vs. continuous demographic X-variable; a separate graph is created for each unique treatment or period.

[PKParam]_Norm-[Demog]_Trt_vs-Cont-[Demog]^a 

Normalized PK parameter vs. continuous demographic X-variables, where a separate graph is created for each unique treatment or period.

[PKParam]_Strat-[Demog]_vs-Cont-[Demog] 

PK parameter vs. continuous demographic X-variables; all individual subjects for all treatments or periods are displayed on same graph, legend includes stratified demographic values (e.g. Male, Female).

[PKParam]_Norm-[Demog]_Strat-[Demog]_vs-Cont-[Demog] 

Normalized PK Parameter vs. continuous demographic X-variables; all individual subjects for all treatments or periods are displayed on same graph, legend includes stratified demographic values (e.g. Male, Female).

[PKParam]_Trt_GroupBy-Strat-[Demog]_vs-Cont-[Demog]^a 

PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique treatment or period, legend includes stratified demographic values (e.g. Male, Female).

[PKParam]_Norm-[Demog]_Trt_GroupBy-Strat-[Demog]_vs-Cont-[Demog]^a 

Normalized PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique treatment or period, legend includes stratified demographic values (e.g. Male, Female).

[PKParam]_Strat-[Demog][Value]_vs-Cont-[Demog] 

PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique demographic variable value (e.g. Male or Female), legend includes treatments or periods.

[PKParam]_Norm-[Demog]_Strat-[Demog][Value]_vs-Cont-[Demog] 

Normalized PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique demographic variable value (e.g. Male or Female), legend includes treatments or periods.

^aFor replicated studies, _Per appears after _Trt to indicate the specific period the graph is representing.

^bFor stratifications, if legend is “Summary only” or “Individual and Summary,” Variable symbols are applied to Summary lines so each is distinguishable.

PK Automation Graphs by Study Design, Dosing, and Matrix 

The following table details which graphs are available for each study type, dosing, and matrix. Abbreviations in the table include:

SD: Single-Dose applies to Plasma

MD: Multiple-Dose applies to Plasma

TR: Trough

UR: Urine

PK Comparison graphs

Depending on Admin and interface settings, PK Comparison projects can produce combinations of the graphs listed below. The table following the list summarizes the availability of each graph by comparison type. Graph file names marked with an asterisk have example output graphs located in the “Comparison Output Examples” section.

*Comp_Conc_by_Subject_Lin/Log 

Overlay time-concentration graph of all treatment and period with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…) per subject. One graph per subject independent of number of treatments and analytes. Activate Comparison Individual Time Conc checkbox in the Appendix list to incorporate these graphs into a Word file called Comparison_Individual_Time_Conc.doc.

*Comp_Summary_Conc_Lin/Log 

Summary overlay time-concentration graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per run independent of number of subjects, treatments, and analytes.

*Comp_Excretion_Rate_by_Subject_Lin/Log 

Overlay excretion rate graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…) per subject. One graph per subject independent of number of treatments and analytes. Activate Comparison Individual Excretion Rate by Subject checkbox in the Appendix list to incorporate these graphs into a Word file called Comparison_Individual_Excretion_Rate.doc.

*Comp_Summary_Excretion_Rate_Lin/Log 

Summary overlay excretion rate graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per run independent of number of subjects, treatments, and analytes.

*Comp_Cumulative_Amount_Excreted_by_Subject_Lin/Log 

Overlay of the cumulative amount of urine excreted by subject for all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per subject independent of number of treatments and analytes. Activate Comparison Individual Cumulative Amount Excreted by Subject checkbox in the Appendix list to incorporate these graphs into a Word file called Comparison_Individual_Cumulative_Amount_Excreted.doc.

*Comp_Summary_Cumulative_Amount_Excreted_Lin/Log 

Summary overlay line graph of the cumulative amount of urine excreted by treatment vs. midpoint or end time. Error bars are available.

*Comp_Amount_Excreted_by_Subject_Lin/Log 

Overlay line graph of the amount excreted by subject per treatment vs. midpoint or end time.

*Comp_Summary_Amount_Excreted_Lin/Log 

Comparison overlay line graph of the summary amount excreted vs. the midpoint or end time. Error bars are available.

*Comp_Percent_Dose_Remaining_by_Subject_Lin/Log 

Overlay line graph of the percent dose remaining by subject per treatment vs. midpoint or end time.

*Comp_Summary_Percent_Dose_Remaining_Lin/Log 

Comparison overlay line graph of the summary percent dose remaining vs. the midpoint or end time. Error bars are available.

*Comp_Trough_Conc_by_Subject_Lin/Log 

Overlay trough time-concentration graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…) per subject. One graph per subject independent of number of treatments and analytes. Activate Comparison Individual Trough Time checkbox in the Appendix list to incorporate these graphs into a Word file called Comparison_Individual_Trough_Time.doc.

*Comp_Summary_Conc_Lin/Log (Trough)

Summary overlay trough time-concentration graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per run independent of number of subjects, treatments, and analytes.

*Comp_[PKParam] 

Individual and summary overlay PK parameter graph of all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on X-axis. One graph per PK parameter per run independent of number of treatments or periods, analytes, days, or subjects. All Comparison types included.

Comp_[PKParam]_Norm-[Demog] 

Individual and summary overlay normalized PK parameter graph of all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on X-axis. One graph per PK parameter per run independent of number of treatments or periods, analytes, days, or subjects.

*Comp_Box_[PKParam] 

Box & whisker plot of PK parameter for all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on X-axis. One graph per PK parameter per run independent of number of treatments or periods, analytes, days, or subjects. All Comparison types included. Requires at least three subjects in the study.

Comp_Box_[PKParam]_Norm-[Demog] 

Box & whisker plot of normalized PK parameter for all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on X-axis. One graph per PK parameter per run independent of number of treatments, periods, analytes, days, or subjects. Requires at least three subjects in the study.

*Comp_[PKParam]_vs-Cont-[Demog] 

Individual scatter plot of PK parameter graph vs. continuous demographic of all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on legend. One graph per PK parameter per run independent of number of treatments periods, analytes, days, or subjects.

Comp_[PKParam]_Norm-[Demog]_vs-Cont-[Demog] 

Individual scatter plot of PK parameter graph vs. continuous demographic all each treatment and period with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on legend. One graph per PK parameter per run independent of number of treatments, periods, analytes, days, or subjects.

*Comp_[PKParam]_Trt or _Per_vs-Cont-[Demog] 

Individual scatter plot PK parameter graph vs. continuous demographic of each treatment or period with all possible Analyte (Analyte–Plasma/Urine) or Day (Accumulation) combinations displayed on legend. One graph per PK parameter per treatment or period per run independent of number of analytes, days, or subjects.

Comp_[PKParam]_Norm-[Demog]_Trt or _Per_vs-Cont-[Demog] 

Individual scatter plot PK parameter graph vs. continuous demographic of each treatment or period with all possible Analyte (Analyte–Plasma/Urine) or Day (Accumulation) combinations displayed on legend. One graph per PK parameter per treatment or period per run independent of number of analytes, days, or subjects.

Comparison Graphs by Type and Matrix 

The following table details the graphs that are available for each comparison study type and matrix.

(In the following table “Pl” = Plasma, “Ur” = Urine, “Tr” = Trough, “Acc” = Accumulation, “AbBio” = Absolute Bioavailability, “RenCl” = Renal Clearance.)

There are two types of appendix output: PK Automation appendix output and PK Comparison appendix output.

PK Automation appendix output

PK Automation can create the following output as Microsoft Word documents.

Time-Concentration/Excretion Rate/Percent Dose Remaining (one document per subject graph)

Individual_Time_Concentration.doc

Individual_Excretion_Rate.doc

Individual_Percent_Dose_Remaining.doc

Individual_Cumulative_Amount_Excreted.doc

Individual_Amount_Excreted.doc

PK Parameter 

Summary_PK_Text.doc: Individual regression fit, one subject per graph and listing of the individual PK parameter values selected for display in the tables.

If Phoenix cannot create a regression line (for instance, when concentration increases over time), AutoPilot Toolkit cannot generate this document, since it is based. To force a regression line, set the start and stop times in Phoenix larger than t_last.

Any selections made to the X-axis scaling, including uniform vs. non-uniform scaling, user-defined tick mark settings, and any options to start the X-axis at time=0, are only applied to the JNB, WMF, and EMF output objects and not to the charts in this document.

PK Automation appendix output by study design, dosing, and matrix 

The following table details the Word documents that are available by study design, dosing, and matrix.

Each Individual Time-Concentration, Excretion Rate, or Percent Dose Remaining document is a single Word document containing individual graphs with one subject per graph. The legend indicates all treatments and periods. The graphs are created by Phoenix and inserted, in Windows Metafile format, into the Word document.

Each page of the Summary PK Text document contains a graph and a table of PK parameter values for one profile, where a profile is defined as one unique combination of values for the sort variable(s) selected in the NCA model (e.g., Treatment_Description, Period, Day). The graph is displayed at the top of the page, with the PK parameters below. The graph is a copy of the regression fit created during the NCA run.

Note:    The Summary PK Text document only includes values for parameters from non-excluded tables (PK Parameter, Intext, Lambda_Z tables). If only stratified and excluded tables are created, the document will not include the table of PK parameters per profile.

The display names for the graphs and tables, the parameters available for inclusion in the output and the option of including source information in the document are all Admin settings. If source information is included in the document is presented as one footnote per automation run. The footnote is displayed in the right lower margin of page. See the “Managing footnotes” section for further details.

PK Comparison appendix output

The following table details the Word documents that are available by comparison type and matrix.

(In the following table “Pl” = Plasma, “Ur” = Urine, “Tr” = Trough, “Acc” = Accumulation, “AbBio” = Absolute Bioavailability, “RenCl” = Renal Clearance.)

The Individual Time-Concentration and Excretion Rate documents combine individual graphs, one subject per graph, with all combinations of analytes, days, treatments, periods in the legend. The graphs are created by Phoenix and inserted in Windows Metafile format into a Word document. The settings for the text objects from the automation runs used apply.

Legal Notice | Contact Certara
© Certara USA, Inc. All rights reserved.