Enhance your clinical development program with our modeling and simulation services. Quotient Sciences’ experts’ help you pinpoint the question you need to answer and identify the data you need to collect.
Our Modeling and Simulation (M&S) team possess 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 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 life-cycle management.
Why perform modeling and simulation with Quotient Sciences?
- Your first-in-human or drug optimisation program, using our integrated Translational Pharmaceutics approach, 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, drug metabolism and pharmacokinetic (DMPK) data
- Our team have successfully provided GastroPlus™ consultancy services for over five years, partnering with virtual biotech to large pharma 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 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 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 modeling and simulation activities span early clinical development through to life cycle 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.
PBPK Modelling & Simulation
Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies.
Tufts CSDD Study Assessing the Financial Benefits of Translational Pharmaceutics®: A Platform for Accelerating Product Development
This webinar will summarize the key findings of the recent Tufts CSDD research into Translational Pharmaceutics, the innovative approach to drug development. It demonstrates significant time savings of >12 months and financial gains of >$100 million per drug approved.
AAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug Development
Presented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.
AAPS 2019 Poster- Comparison of Two In-Silico Modeling Programs, ADMET Predictor® and Percepta® to Predict Intrinsic Solubility and pKa of Poorly Soluble Drugs
Presented at AAPS 2019: Aqueous solubility is a prerequisite for oral absorption of a drug and the pH-dependence of aqueous solubility is critical information to guide formulation development strategies. The purpose of this study was to evaluate the physical property modules in two commercially available in-silico modelling programs in predicting the pH solubility profiles as described by the ionization constant (pKa) and the intrinsic solubility of the unionized form.