An accelerating pipeline of candidate drugs is emerging from discovery, waiting for in vivo evaluation of PK before they can be pushed through to later stages of development. The ever- increasing cost of clinical development is forcing more elaborate and intensive evaluations of PK/PD at earlier stages of development. The FDA Critical Path Initiative calls for greater use of PK/PD modeling. As a result, leading companies are turning to technology to improve productivity and leverage scarce scientific talent in PK/PD analysis, modeling, and reporting. This document covers the PK/PD data problem and the benefits of a clinical pharmacology data repository.
Managers of PK/PD data confront three growing and critical problems:
- How to provide high-quality, regulatory-compliant storage and analysis of PK data
- How to optimize PK/PD modeling and simulation workflows
- How to speed data transfer between users in different departments or across organizations for faster and efficient collaboration without compromising compliance