Microarrays in drug development: regulatory perspective

  • Roland Frötschl
  • Peter Kasper
Part of the Progress in Inflammation Research book series (PIR)


This chapter describes the current status and impact of data from microarray applications on drug development and approval from a European regulator’s point of view.

Microarray technology is regarded as a new, valuable and increasingly important tool in drug development and risk evaluation. The technique may enable faster development of new and safer drugs, even for diseases as yet incurable. Scientists in industry, academia, and regulatory bodies are currently evaluating and discussing what prerequisites are needed to implement microarray data from pharmacogenetic, pharmcogenomic, and toxicogenomic experiments in the regulatory process and for use in risk/benefit evaluations.

The areas where microarray applications are considered meaningful are identified and the activities and expectations of regulatory bodies discussed. The proposed measures of quality control and assurance are presented as outlined in the draft guidance paper by FDA and a draft reflection paper by EMEA. The current discussion on how to define and qualify biomarkers for prediction of pharmacologic/toxicologic effects, and their implementation in the regulatory framework and decision making is described.

In an overview, regulatory experience with microarray data submissions so far is presented. Our general expectation is that requests for pharmacogenetic briefing meetings and voluntary genomics data submission will increase substantially in the near future, also leading the way to increasing data submissions with marketing applications.


Microarray Data Drug Development Regulatory Body Risk Evaluation Regulatory Framework 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Birkhäuser Verlag Basel/Switzerland 2008

Authors and Affiliations

  • Roland Frötschl
    • 1
  • Peter Kasper
  1. 1.Federal Institute for Drugs and Medical Devices (BfArM)BonnGermany

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