Global Bioanalysis Consortium (GBC)


At a Glance
  • Status: Completed Consortium
  • Year Launched: 2010
  • Initiator Type: Industry
  • No disease focus
  • Location: International

Abstract

The Global Bioanalysis Consortium (GBC) is a worldwide organization consisting of representatives of scientific associations with the mission to harmonize and merge existing or emerging bioanalytical guidances to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.

Mission

GBC’s mission is to bring together stakeholders from the pharmaceutical industry, contract research organizations, and academia to share current understanding of bioanalysis guidelines and identify differences in these guidelines or differences in the interpretation or application thereof to routine regulated bioanalysis. Its goal is to formulate recommendations to health authorities and regulatory bodies worldwide on globally agreed best practices for bioanalytical method validation and application of such methods/technologies to the analysis of drugs of all molecular sizes in support of clinical and nonclinical studies.

Consortium History

May 2013: Held two webinars on the outcomes of the GBC harmonization teams on bioanalytical method validation

Structure & Governance

GBC is led by a Steering Committee that oversees a Scientific Leadership Team and several harmonization teams. Harmonization teams exist under three categories: all molecules, small molecules, and large molecules.


Last Updated: 04/18/2016

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