The
draft ICH guidance is currently out for review. This proposed new
multidisciplinary guideline will address the validation of bioanalytical
assays. This guideline will provide recommendations on how to validate a
bioanalytical assay for drug quantification and how to apply validation during
study sample analysis. However, this guideline does not provide recommendations
which analyte should be analysed. This is covered in other ICH and regional
regulatory documents.
The
draft looks at:
Concentration
measurements of chemical and biological drug(s) and their metabolite(s) in
biological matrices are used as part of regulatory decisions regarding the
safety and efficacy of drug products. It is therefore critical that the
bioanalytical methods used are well characterised, appropriately validated and
documented in order to ensure reliable data to support regulatory decisions.
The objective of the validation of a bioanalytical assay is to demonstrate that
it is suitable for its intended purpose. This guideline is intended to provide recommendations
for the validation of bioanalytical assays for chemical and biological drug quantification
and their application in the analysis of study samples.
See:
https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validationPosted by Dr. Tim Sandle, Pharmaceutical Microbiology
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