Assessment of Gastrointestinal and Pancreatic Toxicities

Adverse gastrointestinal events are not uncommon in early clinical trials because one objective of these studies is to assess tolerability however, these effects are not always related to the pharmacology of the compound. Of the top 100 most frequently prescribed medications, 44 have been implicated in episodes of acute pancreatitis (Trivedi and Pitchumoni 2005). There is an objective to improve assessment of gastrointestinal toxicities by biochemical analyses in addition to enhancing safety pharmacology studies. Many of the mechanisms that cause gastrointestinal and pancreatic toxicity are poorly understood. 

Although several enzyme measurements are available for assessing gastrointestinal function, these assays are not frequently used amylase and/or lipase are perhaps measured more often than other enzymes in order to evaluate pancreatic toxicity. Some enzyme measurements require the invasive collection of gastric, pancreatic, and intestinal fluids, or tissues and therefore are not suitable for many toxicological studies. 

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