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However, methodological heterogeneity still limits inter-study comparability and hinders integrated interpretation, calling for more consistent experimental frameworks

Jan 1992;55(1 Suppl):314s-317s
The ability to detect a safety signal in an FIH study is determined by the total number of subjects in the study as a whole as well as the size of each dose cohort, the actual event rate that the experimental agent would cause if given to a large population and the spontaneous background rate (nondrugrelated toxicity) of a given event
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This is where the concept of bioavailabilityhow well your body can actually absorb and use what it takes inbecomes the most important part of the conversation
