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The European Medicines Ageny (EMA) announced today that it released a new guideline on the validation of bioanalytical methods applied for quantitative analysis of biological samples collected for pharmacokinetic and toxicokinetic parameter determinations.  The guideline is a continuation of the FDA guidance for industry released 10 years ago, and accommodates the rapidly increasing number of macromolecular drugs pushed to market by the pharmaceutical and biotechnology community.

In terms of ligand binding assay validation (e.g. assays like sandwich hybridization, real-time RT-qPCR, immunogenicity assays, or real-time immuno qPCR assays), the acceptance criteria were eased (e.g. from 20% to 30% at LLOQ). At the same time, the experimental effort was adopted to encounter the inherent variability of ligand binding assays (e.g. selectivity testing by spiking 10 sources of sample matrix rather than only 6 samples).

As the EMEA guideline will be effective from 01 February 2012, Accelero Bioanalytics will apply the required validation criteria for all ligand binding assay validations initiated after the effective date.

Additional informations or web recources:

EMEA Guideline on bioanalytical method validation, Release July 21, 2011

FDA Guidance for Industry: Bioanalytical Method Validation, Release May 2001