Science Pool

Modelling Antibiotic Efficacy using PK/PD

PK/PD modelling is an important aspect of dose prediction of antibiotics for both preclinical and clinical development and is a requirement of both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). This technique facilitates efficient dose-response study designs and assists in identifying optimal dosing regimens to ensure clinical efficacy and to suppress drug resistance.

Cyprotex is increasingly supporting its parent company, Evotec, in the modelling and simulation area. For example, mathematical modelling techniques have been applied in the rational design of antibiotic efficacy studies to reduce the number of animals required to determine the magnitude of efficacy and pharmacodynamic driver and promote acceptance of such data by regulatory authorities.

Our research poster, titled Pharmacokinetic/Pharmacodynamic Modelling of Antibiotic Efficacy, was presented at the Alderley Park 3R’s Poster Event on 17th October 2018. The event was jointly hosted by AstraZeneca, Cancer Research UK and Agenda Life Sciences. The poster was awarded 1st prize in the event for its contribution to the 3R’s concept of Replacement, Reduction and Refinement.

The contemporary definitions of the 3Rs are:
• Replacement: accelerating the development and use of models and tools, based on the latest science and technologies, to address important scientific questions without the use of animals.
• Reduction: appropriately designed and analysed animal experiments that are robust and reproducible, and truly add to the knowledge base.
• Refinement: advancing animal welfare by exploiting the latest in vivo technologies and by improving the understanding of the impact of welfare on scientific outcomes.

In silico modelling and simulations can be used to improve study designs leading to a significant reduction in the number of animals required to achieve experimental objectives.

You can read more in our poster.