Electroanalytical methods are chosen for the sensitive analysis of pharmaceutically active compounds in their dosage forms and biological samples. Electroanalytical method validation is the process used to confirm that the determination procedure employed for a specific test is suitable for its intended use like other analytical methods. Results from electroanalytical method validation can be u...

abstract: An analytical method validation represents a complete investigation of the materials’ properties, following certain steps, being necessary for “proving the fit for purpose of an analytical method”. The validation procedure demonstrate that a defined validation protocol for an analytical method applied to a specified testing material and a defined concentration of the analyt – named an...

The paradigm of contractual specification provides a transparent way of specifying object-oriented systems. In this paradigm, system consistency is specified using so-called invariants. Runtime validation of invariants is a complex problem. Existing validation methods require either exhausting validation of an invariant for all objects of the corresponding class or the use of restrictive type s...

It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. In this update on analytical quality, we place validation of analytical methodologies in the broader context of quality assurance (QA). We discuss different approaches to validation, giving atte...

The introduction of new anticancer drugs into the clinic is often hampered by a lack of qualified biomarkers. Method validation is indispensable to successful biomarker qualification and is also a regulatory requirement. Recently, the fit-for-purpose approach has been developed to promote flexible yet rigorous biomarker method validation, although its full implications are often overlooked. Thi...