Supervised Machine Learning-Based Decision Support for Signal Validation Classification.

Journal: Drug safety
Published Date:

Abstract

INTRODUCTION: Signal validation in pharmacovigilance is the process of evaluating data to decide whether evidence is sufficient to justify further assessment of a detected signal. During the signal validation process, safety experts in our organization are required to review signals of disproportionate reporting (SDRs) and classify them into one of six predefined categories.

Authors

  • Muhammad Imran
    Institute of Biochemistry and Biotechnology, University of Veterinary and Animal Sciences, 54000 Lahore, Pakistan.
  • Aasia Bhatti
    Bayer US LLC, Pharmaceuticals, Pharmacovigilance, Benefit-Risk Management TA Radiology, Whippany, NJ, USA.
  • David M King
    Bayer US LLC, Digital Transformation and Information Technology Pharma, Adverse Event Management, Morristown, NJ, USA.
  • Magnus Lerch
    Lenolution GmbH, Berlin, Germany.
  • Jürgen Dietrich
    Bayer AG, Pharmaceuticals, Pharmacovigilance, Innovation and Digitalization, Berlin, Germany.
  • Guy Doron
    Bayer AG, Pharmaceuticals, Pharmacovigilance, R&D, Data Sciences, Berlin, Germany.
  • Katrin Manlik
    Bayer AG, Pharmaceuticals, Pharmacovigilance, Data Science and Insight Generation, Berlin, Germany.