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.

Bioequivalence
Dynakin/ DMC has extensive experience with bioequivalence problem solving employing population PK methods. This rare capability permits a more thorough understanding of the overall equivalence that may exist across separate studies performed by the sponsor but cannot be resolved by classical NCA bioequivalence methods.

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.