The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

Analytical methods and bioassays require a well-thought-out manner of evaluating method validity (truthfulness) and systems suitability (a known positive control) to ensure the method is correct, ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

Calibration in analytical chemistry is fundamental to quantifying substances and ensuring the metrological integrity of measurement systems. By establishing a reliable relationship between the ...