Protocol for PK and Statistical Analysis in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the pharmacokinetic (PK) and statistical analysis of data collected during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in PK and statistical analysis activities, including Pharmacokineticists, Statisticians, Data Analysts, and Study Coordinators.

Responsibilities

• The Pharmacokineticist is responsible for designing and executing pharmacokinetic analysis plans, interpreting PK parameters, and generating PK reports.
• The Statistician is responsible for developing statistical analysis plans, conducting statistical analyses, and interpreting study results.
• The Data Analyst is responsible for extracting, cleaning, and organizing study data for analysis, in collaboration with study personnel.
• The Study Coordinator is responsible for coordinating data collection activities, ensuring data quality and completeness, and providing necessary support to PK and statistical analysis teams.

Procedure

1. Review the study protocol and analysis objectives to develop a PK and statistical analysis plan outlining the analytical approach, statistical methods, and endpoints of interest.
2. Extract and clean study data from the database or data management system, ensuring accuracy, consistency, and completeness of the dataset.
3. Conduct pharmacokinetic analysis using appropriate modeling and simulation techniques to estimate PK parameters such as Cmax, Tmax, AUC, and half-life.
4. Perform statistical analysis of study endpoints using suitable statistical methods, including descriptive statistics, hypothesis testing, regression analysis, and non-parametric tests.
5. Generate summary tables, figures, and listings (TFLs) to present PK and statistical analysis results in accordance with regulatory requirements and study objectives.
6. Review and validate analysis results to ensure accuracy, consistency, and reproducibility, and resolve any discrepancies or data anomalies identified during the analysis process.
7. Prepare pharmacokinetic and statistical analysis reports summarizing analysis methods, results, and interpretations, and provide recommendations for further study or analysis.
8. Archive study data, analysis plans, and reports in accordance with established procedures and regulatory requirements, ensuring data integrity and accessibility for future reference.

Abbreviations

• SOP – Standard Operating Procedure
• PK – Pharmacokinetic
• BE – Bioequivalence
• Cmax – Maximum Concentration
• Tmax – Time to Maximum Concentration
• AUC – Area Under the Curve
• TFLs – Tables, Figures, and Listings

Documents

• PK and Statistical Analysis Plan
• PK and Statistical Analysis Reports
• Analysis Datasets
• Validation Records

Reference

International Conference on Harmonisation (ICH) E9 Statistical Principles for Clinical Trials and relevant regulatory guidance documents for pharmacokinetic analysis and statistical analysis in clinical research.

SOP Version

Version 1.0