The Dynamic Gastric Model
— A biorelevant in vitro model of the human GI tract
Get insights into oral drug behavior with unparalleled accuracy
Our unique Dynamic Gastric Model (DGM), also referred to as the Dynamic GastroIntestinal Model, is an advanced in vitro system for oral drugs that simulates the complex dynamics of the stomach and intestine, providing key insights under gastrointestinal conditions.
With the DGM we replicate your exact clinical or pre-clinical protocol and predict oral drug dosage form behavior and Pharmacokinetics profiles (PK).
Examples of Collaborations:
The Dynamic Gastric Model
— A biorelevant in vitro model of the human GI tract
Get insights into oral drug behavior with unparalleled accuracy
Our unique Dynamic Gastric Model (DGM), also referred to as the Dynamic GastroIntestinal Model, is an advanced in vitro system for oral drugs that simulates the complex dynamics of the stomach and intestine, providing key insights under gastrointestinal conditions.
With the DGM we replicate your exact clinical or pre-clinical protocol and predict oral drug dosage form behavior and Pharmacokinetics profiles (PK).
Examples of Collaborations
Bioneer is a center of excellence for gastro-intestinal (GI) modelling. Watch how the model works.
Bioneer is a center of excellence for gastro-intestinal (GI) modelling. Watch how the model works.
With the DGM you gain valuable insights into:
- Clinical performance
- Preclinical performance
- Formulation ranking
- Bioequivalence
- Food effects
- Hypochlorhydria effects
- Modified/targeted release
- Dose dumping
- Formulation digestion/degradation
- Gastric integrity
Cost-effective and ethical alternative
In April 2025 the FDA announced a plan to phase out the animal testing requirement for monoclonal antibodies and other drugs — a significant step toward making non-animal methods a regulatory standard.
We support the shift to replace animal testing with human-based in vitro models such at the Dynamic Gastric Model, wherever applicable.
The model provides a cost-effective and ethical alternative to improve the design of clinical trials and reduce reliance on animal studies by closely mimicking human gastrointestinal physiology.
How the Dynamic Gastric Model works
As illustrated above, the Dynamic Gastric Model reproduces the human stomach and intestine in vitro.
With the DGM you can:
• Recreate the body/fundus and antrum, where storage, digestion, and peristaltic movements are simulated through hydrodynamics.
• Select fasted or fed state to match your clinical protocol.
• Simulate gastric digestion and emptying into the intestine.
• Assess the influence of pH, bile, enzymes, food, and fluid dynamics on drug release and dissolution.
• Generate PK predictions with reliable in vitro–in vivo correlation (IVIVC).
Optional pre-screening
As an optional, but natural add-on to DGM modelling, we offer a standard dissolution screening of your candidates. This extra step provides a baseline dissolution profile, helping you prioritize the most promising compounds for further study in the DGM and makes your studies more efficient, focused, and informative.
Our dissolution services draw on advanced methodologies such as the MicroDISS and the MicroFLUX for precise small-scale testing and lipolysis for simulating digestive processes. This ensures you gain comprehensive insight into drug dissolution behavior before moving into dynamic gastric modelling.
FAQ: The Dynamic Gastric Model
General questions
How does the DGM differ to alternative technologies?
Most alternative in vitro models provide only static or semi-dynamic conditions, which cannot fully reproduce the complexity of the human stomach.
The Dynamic Gastrointestinal Model simulates the stomach’s hydrodynamics, biochemical composition, and peristaltic movements, and can extend into the small intestine for full upper GI simulation.
The model can furthermore contain the full amount of any given meal, giving the ability to replicate exact clinical or pre-clinical protocol with no need to scale on dosage amount.
This allows prediction of dosage form behaviour and drug dissolution under realistic gastro-intestinal conditions, supporting applications from bioequivalence and food-effect studies to complex modified-release systems — all with clinically relevant, non-animal data.
Can the Dynamic Gastric Model replace animal studies?
While not always a direct replacement, the DGM is a powerful in vitro-based alternative that can reduce reliance on animal models, de-risk clinical studies, and support the shift toward human-relevant testing methods in line with regulatory trends.
Service-related questions
What kind of studies can you run with the Dynamic Gastric Model?
The DGM is highly versatile and can be applied across a wide range of oral drug development studies — from understanding dosage form behaviour and bioequivalence to evaluating food effects, modified release systems, and special populations.
What kind of drug products can be tested?
The DGM can be used to study most APIs, especially BSC class I and II drugs, and drug delivery forms such as tablets, capsules, particulate systems, and more.
How reliable are the results?
The DGM has demonstrated strong in vitro–in vivo correlation (IVIVC), meaning the data often translate well into clinical outcomes.
Read our peer-reviewed article Predicting the pharmacokinetics and food effect of oral drug products using the dynamic gastrointestinal model (DGM) here
Who are your typical customers?
Typical customers for the DGM include pharmaceutical and biotech companies looking to optimize oral drug formulations, evaluate bioequivalence, study food effects, or reduce reliance on animal testing. See examples of DGM users at the top of the page.
Practical questions
How long does a typical study take?
Depending on the dosage amount and the study protocol, our studies typically run between 2-6 weeks. A single fasted-state run takes around 30 minutes and a single fed-state run takes around 5 hours.
How does a project usually proceed?
Prior to project start, we will coordinate with you on the study design. The samples in question will then be shipped to our DGM laboratory, where we will perform the analysis. Afterward, we will carry out the data analysis and provide a report along with a follow-up discussion. Throughout the process, we will stay in close contact and be available for any questions or clarifications.
Where are the DGM studies performed?
All DGM studies are conducted at the Bioneer Pharmaceutical Development site in Copenhagen, Denmark. This 180 m² facility includes offices and laboratories, and is fully equipped for DGM studies.
Our main site in Hørsholm, 20 minutes north of Copenhagen in the SCION-DTU Science Park, hosts additional offices and state-of-the-art lab and manufacturing facilities.
FAQ: The Dynamic Gastric Model
General questions
How does the DGM differ to alternative technologies?
Most alternative in vitro models provide only static or semi-dynamic conditions, which cannot fully reproduce the complexity of the human stomach.
The Dynamic Gastrointestinal Model simulates the stomach’s hydrodynamics, biochemical composition, and peristaltic movements, and can extend into the small intestine for full upper GI simulation.
The model can furthermore contain the full amount of any given meal, giving the ability to replicate exact clinical or pre-clinical protocol with no need to scale on dosage amount.
This allows prediction of dosage form behaviour and drug dissolution under realistic gastro-intestinal conditions, supporting applications from bioequivalence and food-effect studies to complex modified-release systems — all with clinically relevant, non-animal data.
Can the Dynamic Gastric Model replace animal studies?
While not always a direct replacement, the DGM is a powerful in vitro-based alternative that can reduce reliance on animal models, de-risk clinical studies, and support the shift toward human-relevant testing methods in line with regulatory trends.
Service-related questions
What kind of studies can you run with the Dynamic Gastric Model?
The DGM is highly versatile and can be applied across a wide range of oral drug development studies — from understanding dosage form behaviour and bioequivalence to evaluating food effects, modified release systems, and special populations.
What kind of drug products can be tested?
The DGM can be used to study most APIs, especially BSC class I and II drugs, and drug delivery forms such as tablets, capsules, particulate systems, and more.
How reliable are the results?
The DGM has demonstrated strong in vitro–in vivo correlation (IVIVC), meaning the data often translate well into clinical outcomes.
Read our peer-reviewed article Predicting the pharmacokinetics and food effect of oral drug products using the dynamic gastrointestinal model (DGM) here
Who are your typical customers?
Typical customers for the DGM include pharmaceutical and biotech companies looking to optimize oral drug formulations, evaluate bioequivalence, study food effects, or reduce reliance on animal testing. See examples of DGM users at the top of the page.
Practical questions
How long does a typical study take?
Depending on the dosage amount and the study protocol, our studies typically run between 2-6 weeks. A single fasted-state run takes around 30 minutes and a single fed-state run takes around 5 hours.
How does a project usually proceed?
Prior to project start, we will coordinate with you on the study design. The samples in question will then be shipped to our DGM laboratory, where we will perform the analysis. Afterward, we will carry out the data analysis and provide a report along with a follow-up discussion. Throughout the process, we will stay in close contact and be available for any questions or clarifications.
Where are the DGM studies performed?
All DGM studies are conducted at the Bioneer Pharmaceutical Development site in Copenhagen, Denmark. This 180 m² facility includes offices and laboratories, and is fully equipped for DGM studies.
Our main site in Hørsholm, 20 minutes north of Copenhagen in the SCION-DTU Science Park, hosts additional offices and state-of-the-art lab and manufacturing facilities.
Contact us for a free consultation
Interested in learning how we can support your project or pipeline?
We offer a free initial consultation to explore your needs.
For further information please contact Business Development Manager Philip Carlsen on pca@bioneer.dk or +4521679734
