PK/PD & Drug - disease models

DynaKin accompanies the pharmaceutical industry in the Clinical R&D process providing an integrated analysis of client data through the development of pharmacostatistical models that summarize key knowledge about the drug (PK and PD), subjects treated (through covariates) and the course of the disease: Model Based Drug Development. For many therapeutic areas with long term or chronic treatment and long term primary clinical outcomes, the PD part involves very complex usually custom designed disease models, which may include biomarker models as predictor of clinical outcome, disease progression – placebo models, drop-out models, etc. That effort in the translational approach starts at the pre-clinical stage and continues up to approval.

These predictive quantitative models can then simulate the plausible outcomes and constitute a basis for drug development knowledge management and for key decision making by providing conclusive and confirmatory information about safety and efficacy of a drug.

 

© 2009 Dynakin.com