A New Paradigm of Real-Time Data Assembly to Support Knowledge-Based Decision Making: A Case Study

Authors: McPhee ME, Corey A, Reitz K, Grasela TH, Bramer S
Conference: DIA
Keywords: data, data assembly, data warehouse, drug development process, hypertext data analysis mapping, PERSPECTIVE, PKPD methodology, RTDA
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Abstract

Objectives: Real-time data assembly (RTDA) to support knowledgebased decision making was implemented for the development of a compound during Phase II. Program goals were to develop a data warehouse to expedite pharmacokinetic/pharmacodynamic (PK/PD) analyses and perform assessments of factors influencing PK and safety outcomes while maintaining study blinding.

Drug Information Association (DIA), Chicago, Illinois, June 2002

By M. E. McPhee, A. Corey, K. Reitz, Thaddeus H. Grasela, S. Bramer