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 date | 2014 → 2020 |
---|---|
Category of impact | Technological impacts, Economic, Health and wellbeing, Policy |
Impact level | Adoption |
Research Beacons, Institutes and Platforms
- Christabel Pankhurst Institute
- Lydia Becker Institute
Documents & Links
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Research output
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Combining the "bottom-up" and "top-down" approaches in pharmacokinetic modelling: Fitting PBPK models to observed clinical data
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Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: A marriage under the arch of systems pharmacology
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Anatomical, physiological and metabolic changes with gestational age during normal pregnancy: A database for parameters required in physiologically based pharmacokinetic modelling
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Why has model-informed precision dosing not yet become common clinical reality? Lessons from the past and a roadmap for the future
Research output: Contribution to journal › Article › peer-review