14/15 December 2023
The World Health Organization (WHO) has published a draft working document entitled Bioanalytical Method Validation and Study Sample Analysis (QAS/23.925).
The "guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples."
It is divided into the following main chapters:
The text is based on the ICH M10 Guidline from May 2022.
Please also see the following articles in our news archiv for further information:
You can download the document from the WHO Medicines website under "Working documents in public consultation".
Comments should be submitted by 21 January 2024. The WHO asks that comments should be submitted through the online platform PleaseReview™. Further information on the commenting process can be found on the first page of the new document.