The PKanalix Workflows

A typical NCA and CA Workflow with PKanalix

The NCA workflow

1. Set the data

2. Explore the data

   • Interactive plots

   • Table of concentrations

3. Select NCA parameters & calculation settings

   • Add data info (administration type, sparse, observation to use)

   • Add partial AUCs, custom parameters

   • Set BLQ and integral methods

   • Select flags

4. Check slopes for lambda_z calculation

5. Run NCA task

6. Check the individual parameters obtained

7. Get insights with interactive summary statistics table

8. Get insights with interactive diagnostic plots

9. Generate a report

The Bioequivalence (BE) workflow

1. First run the NCA workflow

2. Select BE parameters & calculation settings

3. Set the BE design

4. Run BE task

5. Check the ratios and confidence intervals obtained

6. Get insights with ANOVA (importance of the factors) and coefficients of variation

7. Get insights with diagnostic plots (Sequence by period, Subject by formulation, Confidence intervals)

8. Generate a report

The Compartmental Analysis (CA) workflow

Compartmental Analysis is using a model to fit the individuals one by one. It can be used to compare parameters of a PK model to NCA parameters, or to fit other types of data than PK (PD, joint PKPD…)

1. Set the data

2. Select a model and map observations to model outputs

3. Select settings for the optimization algorithm

4. Set initial values

5. Run CA task

6. Check the diagnostic plots (eg individual fits)

7. Check the estimated parameters

8. Generate a report

and potentially

• Export to Simulx to perform simulations with this model

• Export to Monolix to develop a population model