NCA



SOP

Statistical analysis plan: Make plans for PK analysis.

Import raw data.

Exploratory analysis: make plots based on raw data and check possible data issues.

PK parameter calculation: Pharmacokineticist A uses WinNonlin for NCA.

QC: Pharmacokineticist B uses WinNonlin independently for NCA and get the results compared to A's.

Report: PK reports and QC reports.

Archive: Raw data/NCA documents/PK reports and QC reports.