13/14 October 2021
On 13 March, the EMA published the draft of the "ICH guideline M10 on bioanalytical method validation". In step 2 of the ICH process, the ICH Assembly sends a consensus text or guidance agreed by the relevant ICH Expert Working Group to the regulatory authorities of the ICH regions for internal and external consultation according to national or regional procedures. Accordingly, the EMEA has set a comment deadline of 1 September 2019.
Within the scope of this guideline, the user shall receive assistance for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples. The aim is to improve both the quality and the consistency of the bioanalytical data in the development and marketing approval of chemical and biological drugs by implementing the recommendations given in the document.
A deviation from the given recommendations can be possible, if it is justified with a corresponding scientific rationale. In case of changes or deviation in the validation methodology, the competent regulatory authority should be involved.
For both drugs and their metabolites, measurements of concentrations in biological matrices play a decisive role in development. Data from non-clinical toxicokinetic (TK)/pharmacokinetic (PK) studies and from clinical studies are of decisive importance for the assessment of the safety and efficacy of a drug. This also includes comparative bioavailability/bioequivalence studies (BA/BE). It is therefore essential that the bioanalytical methods used are characterized, validated and documented in detail. Only in this way can high-quality data be generated to enable the relevant regulatory decisions to be made.
This guideline is intended for the validation of bioanalytical methods for the measurement of concentrations of chemical and biological drugs and their metabolites in biological samples such as blood, plasma, serum, other body fluids or tissues. This applies to samples obtained in central non-clinical TK/PK studies and then used for regulatory decisions and all phases of clinical trials in the context of a marketing authorization application.
In the case of studies and trials that are not submitted for regulatory approval or are not considered for safety, efficacy or labelling (e.g. exploratory studies), the respective applicant can decide which level of qualification is sufficient for his internal processes.
Accordingly, the recommendations in this draft shall apply to:
Further details on the content and comments can be found directly in the draft "ICH guideline M10 on bioanalytical method validation".