Modeling and simulation

How do I enhance my clinical development program using modeling and simulation?

Enhance your clinical development program with our modeling and simulation (M&S) services. Quotient Sciences’ experts help you pinpoint the question you need to answer and identify the data you need to collect.

Our M&S team have vast experience performing physiologically based pharmacokinetic (PBPK) modeling. We can provide a mechanistic understanding of the likely performance and disposition of your drug product (generic or new chemical entity [NCE]) in vivo and inform risk-based decisions on formulation and clinical design, ultimately reducing the cost of development. 

The valuable role of M&S in drug development programs is being acknowledged through increasing inclusion in global regulatory submissions. We work collaboratively with you and can provide long-term support to your development programs, from drug discovery to lifecycle management.

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

Our modeling and simulation team

  • 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

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.

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