Bioanalysis is a key component in the trialling of any investigational medicinal product (IMP) and generates the pharmacokinetic, toxicokinetic, and bioavailability/bioequivalence data used for new drug application (NDA) submissions. Accurate and precise bioanalytical methods ensure the integrity of clinical and non-clinical data. Therefore, the data generated from bioanalytical studies safeguards patient safety and drug efficiency. Thorough validation of bioanalytical methods demonstrates that a method is fit for its intended purpose and provides confidence in the data generated.
The implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M10 guidance has significantly impacted bioanalytical method validation. This guideline aims to harmonise global regulatory expectations, replacing the previous guidance documents from the EMA and FDA.
The main advantage of the ICH M10 is its global harmonisation. The reduction of various guidance across multiple territories streamlines the drug development process and reduces costs. The increased clarity and specificity regarding certain validation parameters, like incurred sample reanalysis (ISR) and stability, enhance the consistency and reliability of data from bioanalytical analysis.
In the past, laboratories would implement validation strategies covering the requirements of EMA and FDA guidance if the data would be needed for NDAs in multiple nations. A method validated in accordance with the ICH M10 guidance should not require additional method validation even if the laboratory doesn’t know where the NDA will be submitted.
While many of the requirements for bioanalytical method validation are consistent between the ICH M10 and EMA and FDA guidance (such as precision and accuracy, and selectivity) some parameters have changed. These changes include criteria applied to ISR and stability assessments. The changes required reflect the current best practices for method validation. Methods validated under EMA and FDA guidance can be shown to meet the requirements of ICH M10 with partial validation. A strategy that is common across the industry.
In summary, the ICH M10 guideline has ushered in a new era for bioanalytical method validation. While it demands careful adaptation and resource allocation, its benefits in terms of global harmonisation, enhanced data reliability, and risk-based approaches are undeniable. We must remain vigilant in ensuring that our organisations are effectively implementing these guidelines, thereby maintaining the highest standards of data integrity and patient safety.
