Pancreatic enzyme replacement therapy for pancreatic exocrine insufficiency in the 21st century

Table 5 Data needed to understand how to use new enzyme formulations

Results of all studies should not be withheld but should be published and/or placed on Clintrials.gov within 1 yr of completion

Trial data should provide the primary efficacy endpoint (e.g., coefficient of fat absorption) as mean, standard deviation, median, range, and proportion with coefficient of fat absorption > 90% as well as proportion with coefficient of fat absorption < 85%

Gastric emptying of enteric coated pellets studied for all products are needed and the data should be published and/or placed on Clintrials.gov within 1 yr of completion

Kinetics of dissolution of enteric-coated microbeads in intestinal fluid or simulated intestinal fluid are needed and should include data pH's starting at approximately pH 5 through 7 at increments (e.g., approximately 0.2 pH units)