Protocol for Verification of Bioanalytical Method Performance in BA/BE Studies
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the cross-validation of bioanalytical methods used in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring accuracy, reliability, and consistency of analytical results.
Scope
This SOP applies to all study personnel involved in the development, validation, and implementation of bioanalytical methods for the quantification of drug concentrations in biological samples, including Laboratory Analysts, Data Managers, and Quality Assurance Personnel.
Responsibilities
- The Laboratory Analyst is responsible for performing cross-validation experiments to compare the performance of bioanalytical methods across different laboratories, instruments, and operators.
- The Data Manager is responsible for analyzing and interpreting cross-validation data, assessing method agreement and variability, and documenting results for review and approval.
- The Quality Assurance Personnel is responsible for overseeing the cross-validation process, reviewing and approving validation protocols, and ensuring compliance with regulatory requirements and quality standards.
Procedure
- Develop a cross-validation protocol outlining the objectives, experimental design, acceptance criteria, and statistical methods for evaluating the performance of bioanalytical methods across different laboratories, instruments, and operators.
- Select representative test samples containing known concentrations of analytes of interest and distribute them to participating laboratories for analysis using their respective bioanalytical methods.
- Perform cross-validation experiments according to the protocol, analyzing
Abbreviations
- SOP – Standard Operating Procedure
- BA – Bioavailability
- BE – Bioequivalence
Documents
- Cross-validation Protocol
- Validation Reports
- Statistical Analysis Summary
- Corrective Action Reports
Reference
International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for bioanalytical method validation and cross-validation in clinical research.
SOP Version
Version 1.0