Streamlining the PK/PD data transfer process — 1 year later

Abstract

AbstractThis paper is a follow-up to a paper in issue 3.1 of the Pharmaceutical Programming Journal where we provided an overview of the pharmacokinetics and pharmacodynamics (PK/PD) component of clinical trials as well as an initiative taken by the Biostatistics and Drug Metabolism and Pharmacokinetics (DMPK) departments at Biogen IDEC to develop more efficient processes for the handling and flow of PK/PD data in clinical trials. In this paper we describe the implementation of procedures developed in the initiative and the impact they have had on several clinical programs at Biogen. We have concluded that having a formal PK/PD data flow process has given the DMPK Scientists a place at the table when designing and conducting clinical trials as well as creating efficiencies for all involved functions.