Sound science versus anxiety: validation of bioanalytical assays for small molecules

“Where shall we place the burden of proof when designing validations? We need some guidance in deciding what to investigate, because we have neither the time nor the money to investigate everything.” When we report final bioanalytical quantitative data we occasionally feel some degree of anxiety. Are our data correct? Have the guidelines criteria from authorities been fulfilled and did we follow all our internal standard operation procedures? Are all study data and peripheral data traceable and properly archived? Would the data pass an inspection by authorities if it were to be scrutinized? To a certain degree, anxiety can be...

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