Protocol for Validation of Bioanalytical Methods in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the validation of bioanalytical methods used for the quantitative analysis of drug compounds and metabolites in biological samples collected from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the development, validation, and implementation of bioanalytical methods, including Analytical Chemists, Laboratory Managers, and Quality Assurance personnel.

Responsibilities

• The Analytical Chemist or designated personnel are responsible for developing and validating bioanalytical methods according to established guidelines and regulatory requirements.
• The Laboratory Manager is responsible for overseeing method validation activities, ensuring compliance with SOPs and regulatory standards.
• The Quality Assurance (QA) personnel are responsible for reviewing and approving method validation protocols, reports, and documentation to ensure data integrity and regulatory compliance.

Procedure

1. Plan and design the validation study based on regulatory guidelines, study objectives, and method development results.
2. Conduct pre-validation experiments to optimize method parameters, such as selectivity, specificity, sensitivity, accuracy, precision, and linearity.
3. Prepare a validation protocol outlining the study objectives, experimental design, acceptance criteria, and analytical procedures to be validated.
4. Perform the validation experiments according to the protocol, including sample preparation, analytical measurement, and data analysis.
5. Evaluate