Gastrointestinal (GI) diseases may affect one or more regions of the gastrointestinal tract, including the esophagus, stomach, small intestine, large intestine, or accessory organs such as the liver, gallbladder, and pancreas.
This disease class includes both functional and structural disorders. GI disorders may arise from diverse etiologies, including genetic abnormalities, environmental insults, pathogen exposure, abnormal cell growth, stress, diet, certain medications, and more.
Most gastrointestinal drugs are designed to act locally, with systemic absorption minimized as much as possible. When a drug is absorbed systemically at low levels, informative pharmacokinetic and pharmacodynamic (PK/PD) drug profiles are difficult to obtain and often require modeling and simulation. High quality PK analysis is critical for making substantive arguments regarding exposure-response relationships. Nuventra has extensive experience navigating the hurdles associated with minimal and highly variable PK data.
Nuventra’s Gastrointestinal Experience
Nuventra can perform any of our wide range of services for drugs to treat Gastrointestinal indications. Some of our recent project experience in this area includes:
- Authoring Peer-Reviewed Manuscripts
- Bioanalytical Support
- Clinical Study Design
- CMC Support
- Data Analysis
- Dose Selection
- Modeling and Simulation
- Pediatric Study Plans
- Regulatory Strategy
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Nuventra has experience with a number of gastrointestinal indications, including:
- Eosinophilic Esophagitis
- Fecal Incontinence
- Irritable Bowel Syndrome
- Ulcerative Colitis