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Measurement of drug concentrations in biological matrices (such as serum, plasma, faces, skin, blood, urine, saliva and other organ tissues) is an important aspect of medicinal product development. Such data may be required to support applications for new actives substances and generics as well as variations to authorised drug products. The results of animal toxicokinetic studies and of clinical trials, including bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a medicinal drug substance or product. This guideline provides recommendations for the validation of bioanalytical methods applied to measure drug concentrations in biological matrices obtained in animal toxicokinetic studies and all phases of clinical trials. Furthermore, this guideline will describe when partial validation or cross validation should be carried out in addition to the full validation of an analytical method. This comprehensive review paper describes the introduction, bioanalytical work flow, method development steps, types of extractions, types of method validation, validation parameters, and stability in matrix, micro extraction techniques, and examples of drugs using different sample techniques.