Challenges of analytical method validation for ATMPs
pharmaphorum
JUNE 22, 2023
Challenges of analytical method validation for ATMPs Mike.Hammerton Thu, 22/06/2023 - 08:00 Bookmark this
Method Validation Related Topics 
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EMA publishes updated Q&A for ICH M10
European Pharmaceutical Review
JANUARY 26, 2023
The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation 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.
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