Drug Modeling & Consulting
Population Pharmacokinetic (PK) and pharmacodynamic (PD) methods expanded by M&S techniques, leverage and integrate all available (proprietary and public) for optimal selection of compounds to facilitate clinical development and study designs.
Dynakin offers strong know-how to optimize drug development using pharmacostatistical models that sumarize PK/PD information from different phases of drug development.
This vision matches the FDA Critical Path Initiative in order to increase drug development management and decision making efficiency.
Clinical
Clinical drug development through Phases I, II and III is a key occasion for application of MBDD and adaptive approaches (see e.g. FDA Critical Path Initiative) where added value is produced since critical go/no-go decisions should (and can) be taken as early as possible.
DMC applies Modeling & (trial) Simulation within the learn – confirm paradigm across those Phases to leverage early proprietary and public domain (metadata) knowledge on the compound, the disease, the endpoints and the biomarkers.
DMC scientists have expertise with drug – disease modeling in many key therapeutic areas covering from pre-clinical to Phase IV.
Post marketing
Phase IV post marketing studies have regularly being part of DMC’s external collaborations, often in close contact with patient organizations and clinics.
Software and Data Management
Dynakin licenses industry standard software and custom made traceable scripting.
Software and Data Management
Dynakin licenses industry standard software and custom made traceable scripting.