ICH M10 guideline - a harmonized global approach to bioanalysis
Elżbieta Gniazdowska,
Edyta Gilant,
Katarzyna Buś-Kwaśnik
Abstract:Bioanalytical methods are used in research on small-molecule and large-molecule drug products to determine analytes and their metabolites in biological matrices such as blood, plasma, serum, urine, feces, saliva, other biological fluids, or tissues. Validation of a bioanalytical method is the essential step before the implementation of the method into routine use in toxicokinetic or pharmacokinetic studies. Harmonization of recommendations for the validation of bioanalytical methods has been advocated for many… Show more
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