ICH M10 - Bioanalytical Method Validation

What it says

Bioanalytical methods used to quantify drug and metabolite concentrations in biological matrices, such as plasma or urine, must be validated for accuracy, precision, selectivity, sensitivity, reproducibility and stability, with defined acceptance criteria applied consistently across the studies that rely on the method.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Bioanalytical method validation under this guideline underpins the reliability of pharmacokinetic and bioequivalence data, meaning a poorly validated bioanalytical method can undermine the scientific credibility of an entire clinical or nonclinical study built on its results.
• Because bioanalytical methods are often used across many studies over an extended period, this guideline places particular emphasis on ongoing method performance monitoring, not just a one-time validation exercise.
• Incurred sample reanalysis, a specific check built into this guideline, is used to confirm that a validated method continues to perform reliably on actual study samples, not just validation standards.

What inspectors look for

• Whether bioanalytical method validation data supports the specific concentration range and matrix actually used in the studies relying on that method.
• Whether incurred sample reanalysis was performed and met acceptance criteria, confirming ongoing method reliability on real study samples.
• Whether any change to a validated bioanalytical method during its period of use was evaluated for whether partial or full revalidation was required.

Related regulations