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.
Strategies for Accelerating the Development of Modified Release Oral Forms
MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
Accelerating the Developing of Orphan Drugs for Rare Diseases
Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.
Accelerating the Development of Oncology Medicines
Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.