ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis

The European Medicines Agency (EMA) published an updated Q&A document regarding ICH M10 "Bioanalytical Method Validation and Study Sample Analysis". The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

Background

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. Such concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The draft ICH M10 guideline was published for comments in 2019. The document reached Step 4 of the ICH process in May 2022 including a title change from “Bioanalytical Method Validation” to “Bioanalytical Method Validation and Study Sample Analysis”. Following its implementation on 21 January, the final ICH M10 guideline will replace EMA´s Bioanalytical method validation - Scientific guideline (the US FDA implementation date was 7 November 2022).

How should trends be investigated?

During the ICH M10 comment period, a number of questions have been raised around some of the bioanalytical issues covered in the Guideline. Therefore, the additional Questions and Answers (Q&A) document is intended to provide further clarification. One of the Q&As deals for example with the question on how "Trends of Concern" should be investigated. The Q&A document answers this question as following: "The investigation should be driven by an SOP and should take into account the entire process, including sample handling, processing and analysis. This should also include a scientific assessment of whether there are issues impacting the bioanalytical method, such as interferences and instability".

More information is available under ICH M10 on bioanalytical method validation - Scientific guideline on the EMA webpage.