BIOANALYTICAL METHOD VALIDATION (ICH M10, FDA & EMA)

 The Food and Drug Administration (FDA), European Medicinal Agency (EMA), and International Consortium for Harmonization (ICH)  have issued guidances that are intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples. 


Type of Bioanalytical Method Validation
Full Validation 
Bioanalytical method validation is essential to ensure the acceptability of assay performance and the reliability of analytical results. A bioanalytical method is defined as a set of procedures used for measuring analyte concentrations in biological samples. 

Full Validation

Full validation of a bioanalytical method should be performed when establishing a bioanalytical method for the quantification of an analyte in clinical and in pivotal nonclinical studies. Full validation should also be performed when implementing an analytical method that is reported in the literature and when a commercial kit is repurposed for bioanalytical use in drug development.
A specific, detailed, written description of the bioanalytical method should be established a priori. This description may be in the form of a protocol, study plan, report, or Standard Operating Procedure (SOP).

Partial Validation
Modifications to a fully validated analytical method may be evaluated by partial validation. Partial validation can range from as little as one accuracy and precision determination to nearly full validation. The items in a partial validation are determined according to the extent and nature of the changes made to the method. 

Cross-Validation
Where data are obtained from different methods within or across studies, or when data are obtained within a study from different laboratories applying the same method, comparison of those data is needed and cross-validation of the applied analytical methods should be carried out.

Method Validations Parameter Include: 
Reference standards
Critical reagents
Calibration curve
Quality control samples (QCs) 
Selectivity and specificity 
Sensitivity
Accuracy
Precision
Recovery
Stability of the analyte in the matrix
Minimum Required Dilution (MRD)

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