Bioanalytical Method Validation and Study Sample Analysis

New ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” becomes effective 21 January 2023

Concentration measurements of chemical and biological drugs in biological matrices from non-clinical and clinical studies are used as part of regulatory decisions regarding the safety and efficacy of (new) drug products. Therefore, it is important that these measurements are reliable, reproducible and generated by suitable, robust and thoroughly validated bioanalytical methods.

In an effort to provide recommendations and guidelines for bioanalytical method validations, over the years an increasing number of country-specific documents were released. Although all these guidelines pursued the same goal; providing robust, valid bioanalytical methods to generate reliable and reproducible concentration data within bioanalysis, the recommendations adopted were not always consistent and equally complete. This gave the bioanalytical world a lot of challenges, extra work, and discussion.

Therefore, the initiative to work towards a harmonized global guidance under the umbrella of ICH was very much welcomed by the bioanalytical community. After a number of years, following a lot of discussions and hard work by the community and regulators, the final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was published and adopted by e.g. EMA and FDA on 24 May 2022. Ultimately, the new guideline will come into effect on 21 January 2023.

Compared to the previously existing guidelines, ICH M10 provides not only harmonization, but also notable differences that can impact bioanalytical method validation and analysis procedures. This means that existing procedures need updates to adhere to the new guideline. Progress consultants can help you by performing a quickscan or an extensive assessment of your current procedures, or those of your suppliers, with respect to the new ICH M10 guidance.