Bioanalysis Zone

Trends in microdosing and other exploratory human pharmacokinetic studies for early drug development

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“…the manufacturing of the drug product for early exploratory studies should occur in a flexible small-scale unit at the site of the clinical study.”

During the last decade there has been considerable attention and efforts by all stakeholders to improve the science and efficiency of drug development. It was the focus of global conferences in the late 1990s and recommendations from these conferences were summarized and discussed in a publication by Lesko et al. with the input of many leading scientists [1]. In their critical path initiative, the US FDA emphasized the need for a new development toolkit to improve predictability and efficiency along the critical path from laboratory concept to commercial product [101].

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