Your partner for pharmaceutical modeling & simulation services
Our modeling & simulation studies are available in either a standalone capacity or integrated with a clinical study conducted at Quotient Sciences. We can help you construct and validate both numerical and mechanistic in-vitro/in-vivo correlations (IVIVCs) to offer significant downstream benefits to your development team, including drug product specification setting, managing pre-/post-approval CMC (chemistry, manufacturing, and controls) changes, and justifying biowaivers.
Other benefits of working with us on modeling & simulation studies include:
Perform FIH predictions
to predict fraction absorbed, maximum absorbable dose, starting dose, and potential dose range of your drug product
Conduct quality-by-design (QbD) assessments
to assess the impact of changes to your drug product’s particle size, shape, or dissolution rate
Assess feasibility of your drug for modified-release product development
for more informed drug development decisions
Predict outcomes in special populations
including pediatrics, renal or hepatic impairment, and diverse ethnicities, to better inform and conduct virtual clinical trials, such as bioequivalence assessments
Why choose Quotient Sciences for modeling & simulation services?
Using Translational Pharmaceutics®, your first-in-human clinical program or drug optimization program benefits from the simulation of exposure profiles, which help to select doses and define robust formulation strategies.
Using GastroPlus™ as well as other tools, we can model your drug product’s physicochemical, biopharmaceutic, and drug metabolism and pharmacokinetic (DMPK) data. We have provided GastroPlus™ consultancy services for over 5 years, partnering with virtual biotech to large pharmaceutical companies.
Learn more about how we can apply Translational Pharmaceutics® along with modeling & simulation services to your next drug program.
