Bioanalytical LCMS Method Development & Validation to Regulatory Standard

Bioanalytical LC-MS/MS

Method Development & Validation to Regulatory Standard

Develop and validate bioanalytical LC-MS/MS methods to ICH M10 / FDA standards.

Description

Bioanalysis in complex matrices is a different discipline. Matrix effects, ion suppression, extraction recovery, and carryover will each quietly wreck a method that looked perfect in neat solution and the regulatory bar for bioanalytical validation is higher and more specific than for a standard assay.

This guide covers the full bioanalytical LC-MS/MS pathway: developing a method that survives real biological matrix, then validating it to current regulatory expectations.

What's inside

•    Sample preparation and extraction for plasma, serum, and complex matrices

•    Managing matrix effects, ion suppression, and recovery

•    MS/MS optimisation: transitions, internal standards, and sensitivity

•    Bioanalytical validation aligned to ICH M10 / FDA guidance

Who it's for: Bioanalytical scientists in pharma, CRO, and clinical labs working in biological matrices.

Your most specialist guide for a distinct, higher-value audience than the general HPLC titles.