Bioanalytical Method Validation

The Bioanalytical method validation includes all of the procedures that demonstrate a particular method used for a quantitative measurement of analytes in a given biological matrix is selective, sensitive, reliable and reproducible for the deliberate use. Measurement of drug concentrations in biological matrices is an important aspect of medicinal product development for those products containing new active substances and generic products. Such data may be required to support new applications as well as variations to licensed drug products. The results of toxic kinetic, pharmacokinetic and bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a medicinal drug substance or product. It is therefore paramount that the applied Bioanalytical methods used are well characterized, fully validated and documented to a satisfactory standard in order to yield reliable results.