Speakers - 2026

Title: Robust LC–MS/MS Bioanalysis for Reliable Bioequivalence

Abstract

Bioequivalence studies play a critical role in the approval of generic medicines and require accurate measurement of drug concentrations in biological samples. The reliability of these studies largely depends on proper biological sample handling, validated analytical methods, and strict compliance with international regulatory guidelines such as ICH and USFDA requirements.

This presentation highlights the key steps involved in biological sample analysis for bioequivalence studies, including sample collection, storage, processing, and quantitative analysis using validated bioanalytical techniques of LCMS/MS. Special emphasis is placed on method validation parameters including accuracy, precision, selectivity, sensitivity, linearity, recovery, matrix effect, and stability testing.

Common analytical challenges such as matrix interference, sample degradation, and variability in pharmacokinetic data are discussed along with practical solutions to minimize errors and ensure data integrity. The importance of Good Laboratory Practices (GLP), documentation, and audit readiness is also emphasized to maintain regulatory compliance.

By strengthening bioanalytical validation processes, bioequivalence centres can ensure reliable pharmacokinetic outcomes, regulatory acceptance, and ultimately patient safety. This work supports the development of high-quality generic medicines and reinforces confidence in bioequivalence data generated for regulatory submission.