Achieving Tactical and Strategic Benefits of PKS

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