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The assay was fully validated according to the guidelines for validation of analytical procedures and the results were satisfactory.
A dengue plaque reduction neutralization test (PRNT) to measure dengue serotype specific neutralizing antibodies for all four virus serotypes was developed, optimized, and validated in accordance with guidelines for validation of bioanalytical test methods using human serum samples from dengue-infected persons and persons receiving a dengue vaccine candidate.
The method used was developed and validated as per ICH (Q2-R1) guidelines for validation of analytical methods [34].
The proposed method is validated according to the ICH Q2 (R1) guidelines for validation of analytical methods.
Recent advances in establishing harmonized guidelines for validation of screening methods are reviewed.
The limit of detection (LOD) and limit of quantification (LOQ) were determined according to ICH guidelines for validation of analytical procedures [19].
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The proposed methods were validated according to the ICH-guidelines for validation of the analytical procedures [20] in terms of the linearity, sensitivity, accuracy, specificity, repeatability and reproducibility.
The validation data, adhered to EMA guideline for validation of bioanalytical methods, showed that the proposed method provides accurate and reproducible results in range of 0.1 50 mg/L with a lower limit of detection of 0.02 mg/L.
Validation according to the new guideline for validation of qualitative screening methods [ 31] is performed.
The method was successfully validated according to the USP<1225> Validation of Compendial Procedures and International Conference on Harmonization (ICH) guidelines Q2 (R1) for validation of analytical procedures: text and methodology [10, 11].
Guidelines for validation and application of typing methods for epidemiology [ 20] proposed that the discriminatory index value for the evaluation of epidemiological data should be upper than 0.95.
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