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Duration must be evaluated for each: Biological model and control group Administration route and schedule Measurement period Molecular, histological, biomechanical or behavioural endpoint Relationship between peptide concentration and response A PK-PD relationship requires pharmacokinetic exposure and pharmacodynamic effects to be measured within a compatible study design

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Thereby, the extent of the obtained beneficial effects largely overrides the range of the beneficial effects commonly reported with the standard cytoprotective agents (for review, see, i.e., [2,3,4,5,6,7,8]) (i.e., prostaglandins’ beneficial effects on stomach [10], intestine [13], liver [80], pancreas [13], kidney [81], and heart [82])