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The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical MethodValidation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.
Depending on the nature of the change, manufacturers may be required to maintain both the pre-and post-change equipment, processes, or methods until all approvals are received. Published November 2019. Published November 2019. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. 5 Ahluwalia, K.,
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