- Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crosGavin R Graff
Penn State Milton S Hershey Medical Center, Penn State Medical School, Department of Pediatrics, Hershey, Pennsylvania 17033 0850, USA
Clin Ther 32:89-103. 2010..The US Food and Drug Administration regulations now require all PERT products to undergo clinical efficacy and safety studies before they can be considered for marketing approval...
- Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm studyGavin R Graff
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, USA
Clin Drug Investig 30:351-64. 2010..In this study in children aged <7 years with EPI due to CF, the new formulation pancrelipase delayed-release capsules (CREON) were clinically comparable with standard therapy in terms of safety, tolerability and efficacy...