WHO Draft Working Document on Bioanalytical Method Validation published for Comments

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14/15 December 2023

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The World Health Organization (WHO) has published a draft working document entitled Bioanalytical Method Validation and Study Sample Analysis (QAS/23.925).

Content

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:

• 1. Introduction
• 2. General principles
• 3. Chromatography
• 4. Ligand binding assays
• 5. Incurred Sample Reanalysis (ISR)
• 6. Partial and cross validation
• 7. Additional considerations
• 8. Documentation
• 9. Glossary

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:

• ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis
• ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments

Download and Comments

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.