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Pancrelipase / Lipase / Digestive enzyme / Enteric coating / Pancreatic lipase / Exocrine pancreatic insufficiency / Chronic pancreatitis / Bioavailability / Infant formula / Enzymes / Chemistry / Biology


022523_Pancreaze_ClinPharm_PREA Pediatric Review
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City

Nutricia / /

Company

Johnson & Johnson / USP / Remaining Lipase Activity After Various Incubation Times / Johnson & Johnson Pharmaceutical Research & Development L.L.C. / /

Country

United States / Netherlands / /

Event

FDA Phase / /

IndustryTerm

food matrix / baby food matrices / acidic food / comparable food compatibility results / soft food / in vitro food compatibility study / drug products / food digestion / pancreatic enzyme products / food / /

MedicalCondition

severe exocrine pancreatic insufficiency / exocrine pancreatic insufficiency / pancreatic insufficiency / inflammatory disorder / diabetes mellitus / diseases / chronic pancreatitis / steatorrhea / cystic fibrosis / /

MedicalTreatment

bypass surgery / enzyme replacement therapy / /

NaturalFeature

PANCREASE MT / /

Organization

Food and Drug Administration / Clinical Division / FDA / OCP Division / /

Person

Tien-Mien Chen / Lanyan Fang / Jang-Ik Lee / /

/

Position

General / Question Based Review General / /

Product

Pancreaze capsules / Pancreaze capsule / Pancrelipase Capsules / The Pancreaze capsules / Pancreaze (pancrelipase) Capsules / Executive Summary Pancreaze (pancrelipase) capsule / /

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