We draw your attention to the fact that the website of the European regulatory agency has published a new guideline on bioanalytical method validation and study sample analysis, “ICH guideline M10 on bioanalytical method validation and study sample analysis” (EMA/CHMP/ICH/172948/2019).
It replaces and supplements the provisions set out in the Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2**) and the corresponding Guideline “Medicinal Products. Bioequivalence Studies” 42-7.3:2020, approved by MoH of Ukraine order No. 2538 of 06 November 2020.
The new guideline has been supplemented with tests on the specificity and reproducibility of repeat injection, and a number of requirements for tests of selectivity, matrix effect, stability, etc. have also been updated.
ICH guideline M10 on bioanalytical method validation and study sample analysis will come into effect on 21 January 2023.
We recommend paying attention to the above changes regarding pharmacokinetic studies when planning or evaluating new studies.
To read the Guideline, follow the link https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m10-bioanalytical-method-validation-step-5_en.pdf
The relevant explanations to the Guideline are provided at the link https://www.ema.europa.eu/en/bioanalytical-method-validation-scientific-guideline
