Population PK/PD Modeling
Regulatory-compliant, population PK and PK/PD analysis and reporting as basis of a regulatory submission package. Analysis and study results are leveraged for supporting dose selection, trial design and clinical development plan strategies.
Integrated drug-disease-trial models accounting for placebo response model are used to optimize clinical development plans by maximizing the therapeutic potential and commercial value of new compounds.
The drug's clinical and commercial potentials and study design performances can be evaluated in-silico using virtual clinical trials by assessing the impact of alternative designs on the study outcomes, and the "what-if" scenarios (e.g., doses, arms, and inclusion/exclusion criteria) before embarking on costly and time-consuming trials.
Clinical Trial Simulation
Clinical Trial Simulation (CTS) are developed for: hypothesis testing, anticipating studies outcomes, evaluating benefit/risk ratio in a future trial, evaluating the potential benefit/interest of alternative designs, reducing the risk of an inadequately informative trial, providing rational criteria for an efficient clinical development plan and for providing quantitative criteria to support strategic decisions.
Modelling and simulation approaches are deployed to prepare and review the Pediatric Investigation Plan (PIP) and to develop extrapolation plan in a pediatric population accounting for differences of pharmacokinetics/pharmacodynamics (PK/PD), disease progression, and clinical response to treatment between adult and target populations.
Submission preparation and attendance to regulatory meetings. Reviewing Clinical Pharmacology sections of the FDA and EMEA briefing documents prior to regulatory submission. Writing summaries of Modelling and Simulation analyses. Support EOP2 regulatory submission
A Model-Based approach provides a quantitative framework to support decision analysis:
Creating alternative development strategies or trial designs to be evaluated;
Constructing a drug-disease model, commercial model and/or a model of the trial or program being evaluated;
Quantifying the clinical and/or economic risk involved in each strategy or trial design and conducting sensitivity analysis;
Documenting the information and logic used in the evaluation; and presenting results and recommendations to the client development team and senior management.
PharmacoMetrica has well documented track records across all development phases and in all major therapeutic areas, including: