The implementation of the In Vitro Diagnostic Regulation (IVDR) has significantly transformed the regulatory and operational ...

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 ...

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. The words ‘method’ and ‘validation’ do not ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

This classroom-based training course looks at all aspects of method validation from start (initial planning) to finish (on-going tracking of performance statistics), including explanations of each ...

Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...