Modeling & Simulation

How do I identify the clinical data needed for my program?

Enhance your clinical development program with modeling and simulation (M&S).

Overview of our modeling and simulation team

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 us?

Our M&S activities span from early clinical development through to lifecycle management and are tailored to answer your specific needs.

  • 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

Quotient Sciences Completes Qualification of GastroPlus® PBPK Modeling Software

Quotient Sciences’ Modeling and Simulation (M&S) team has recently completed qualification of GastroPlus, the software they use for physiologically based pharmacokinetic (PBPK) modeling. This 2-year project reflects Quotient Sciences’ commitment to conducting high-quality modeling work with regard to data integrity.

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