Life Sciences PK/PD Modeling and Simulation Services
PK/PD Modeling and Simulation services by SGS Exprimo.
The implementation of model-based approaches in drug development helps to bring new, safe and effective medicines to patients more efficiently. At SGS Exprimo, we are focused on the application of quantitative, model-based approaches at all stages of pharmaceutical development.
With many years’ experience and the latest software, our modeling and simulation experts provide input that can lead to fewer failed compounds, fewer study failures, and a smaller number of studies needed for registration. We can support to predict the expected results of prospective trials, while optimizing study design to increase the probability of a successful efficacy and safety outcome.
With SGS Exprimo modeling and simulation services, you will benefit from:
- The expertise of a solid team of more than 15 dedicated scientists
- Our extensive experience, gained through performing over 300 modeling and simulation projects
- The latest technologies
- A proven ability to partner and build strong, long-term relationships with our clients
SGS Exprimo services
As a standalone service in collaboration with your own modeling and clinical teams, we can assist in regulatory discussions, or even be part of a full-scope contract research service. At every step of the project, you can expect reporting up to all regulatory standards. We offer the following services:
- Population pharmacokinetics modeling:
- Study design, analysis and interpretation
- State of the art absorption/covariate model building
- Extensive model evaluation
- Advanced PK/PD modeling:
- Design of studies and interpretation of results
- Cutting-edge model development
- Extensive model evaluation
- Simulations based on final model to aid design the next study
- PK/PD modeling for biologics and antibodies
- Pre-clinical PK/PD modeling and inter-species scaling
- Target mediated drug disposition models
- Drug-disease modeling:
- Mechanistic and empirical disease model building
- New drug positioning in therapeutic area
- Linking biomarkers to clinical outcome
- Simulating likelihood of success for clinical trials
- Scaling/extrapolation from adult PK and PD data
- Simulations to aid study design
- Pediatric Investigation Plan (PIP) preparation and/or review
- Regulatory consulting/advice for all aspects of modeling during drug development:
- Reviewing documents prior to regulatory submission
- Writing summaries of M&S work
- Mock advisory committee meeting participation
- Customized training:
- Basic NONMEM Course (public and on-site)
- Clinical trial simulation course (public and on-site)
SGS Exprimo developed Simulo, an in-silico modeling and simulation platform that facilitates complex clinical trial simulations. Simulo offers a modern software solution that implements pharmacokinetic (PK), pharmacodynamic (PD) and disease progression models, run in an accessible, user-friendly, interface. This simulation tool has been developed to explore:
- The time course of drug exposure
- Biomarker response and outcome
- Therapeutic and adverse – observed in clinical studies, in both the individual subject and at population level
Contact SGS Exprimo today to learn how we can help with your PK/PD modeling and simulation requirements.
Visit our SGS Exprimo Modeling & Simulation website page at www.exprimo.com or contact us directly.
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