Modernising Drug Development Practices for Precision Dosing in Diverse Patient Populations

Impact: Technological impacts, Economic, Health and wellbeing, Policy

Narrative

Traditional drug development leads to drug doses that are sub-optimal for >40% of patients, thereby increasing the risk of adverse effects and/or reducing efficacy. This highlights the need to tailor the dose to the individual. The Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester (UoM) has demonstrated significant inter-individual variations in the level of drug-handling proteins. Physiologically-based pharmacokinetic (PBPK) modelling utilised by CAPKR has changed practice in drug development. PBPK is now:

•adopted by the global pharmaceutical industry, 

•part of filing for drug approval to world leading regulatory agencies: (USA, Food and Drug Administration (FDA); Europe, European Medicines Agency (EMA); UK, Medicines and Healthcare products Regulatory Agency (MHRA); and Japan, Pharmaceuticals and Medical Devices Agency), 

•formally regulated by inclusion in FDA/EMA/MHRA guidance for industry.

These processes are now facilitating individualized drug dosing.

Impact date2014 → 2020
Category of impactTechnological impacts, Economic, Health and wellbeing, Policy
Impact levelAdoption

Research Beacons, Institutes and Platforms

  • Christabel Pankhurst Institute
  • Lydia Becker Institute

Documents & Links

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