Modeling and simulation

Our modeling and simulation team

Our M&S activities span from early clinical development through to lifecycle management and are tailored to answer your specific needs. We offer services in either a standalone capacity or integrated with a clinical study conducted at Quotient Sciences that help you:

• 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 (MR) drug product development
• Construct and validate both numerical and mechanistic in-vitro/in-vivo correlations (IVIVCs), which 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
• Predict outcomes in special populations (e.g. pediatrics, renal or hepatic impairment, diverse ethnicities) and conduct virtual clinical trials, such as bioequivalence assessments

Why perform modeling and simulation with Quotient Sciences?

• Using our integrated Translational Pharmaceutics® approach, your first-in-human (FIH) or drug optimization program benefits from the simulation of exposure profiles, which help to select doses and define robust formulation strategies
• The complex interplay between the properties influencing your drug’s bioavailability can be described, understood, and applied in risk assessment and decision-making
• Our multidisciplinary experts use GastroPlus™ to model your drug product’s physicochemical, biopharmaceutic, and drug metabolism and pharmacokinetic (DMPK) data
• Our team have successfully provided GastroPlus™ consultancy services for over 5 years, partnering with virtual biotech to large pharmaceutical companies