An indecent proposal or improved quality of bioanalytical data in clinical studies


“…it is sad that within regulated bioanalysis today, there is little room for experiments and few opportunities to test alternative bioanalytical approaches.” Since the late 1970s and early 1980s, technology in bioanalysis has developed tremendously. I think the most obvious improvement is the increase in sample analysis throughput. However, my aim in this article is to show that the bioanalytical data obtained in those old days were not qualitatively inferior, but to some extent were superior to the data obtained in contemporary bioanalysis. Approximately 30 years ago, samples in clinical pharmacokinetic (PK) investigations were often analyzed as duplicates, a procedure...

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