Modeling and simulation

We can help you pinpoint the question you need to answer and identify the data you need to collect to enhance your clinical development program.

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

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.

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

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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