Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept

Application of the β-expectation tolerance interval to method validation of the M30 and M65 ELISA cell death biomarker assays

“…Its success is based on an accurate assessment of the error associated with each parameter by the accumulation of large sets of population data [35,41]. The third approach which is referred to as the difference approach, and is less frequently utilised in biomarker research, if at all, is performed using statistical hypothesis testing [36]. Fig.…”

“…There are 3 classic approaches in validation to decide whether the technical characteristics of an analytical method are performing within specifications to an acceptable level [34][35][36]. The first referred to as the descriptive or 'fixed' criterion [37] decision rule, is when an acceptance limit is set a priori to the experimental phase, normally based on the desired level of performance expected from the particular class of assay under investigation, usually agreed through international standardisation [38][39][40].…”

Critical review of near-infrared spectroscopic methods validations in pharmaceutical applications

“…From the reviewed literature, the decision methodologies used to assess the validity of analytical methods can be classified in four main categories [63]. The first category is the descriptive approach which uses statistical descriptive parameters that are compared to predefined acceptance limits.…”

Determination of binary polymorphic mixtures of fluconazole using near infrared spectroscopy and X-ray powder diffraction: A comparative study based on the pre-validation stage results

“…In previous works, accuracy profiles, a statistical approach based on ␤-expectation tolerance intervals was found to be advantageous to evaluate quantitative method accuracy in pre-validation and validation stages [18][19][20].…”