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Project

A Pharmacometrics Approach to Guide Dose Optimization of anti-infective drugs in special patient populations

In drug development, “one dose fits all” is a key objective. However, variability in exposure, is common and can result in suboptimal treatment of individual patients. To hit a predefined exposure target in each patient, therapeutic drug monitoring (TDM) is often implemented. TDM helps improving attainment of a desired target by guiding individualized dosing based on drug concentrations. Population pharmacokinetic (popPK) models can be used to maximize the success of TDM. Model-informed TDM can be applied to predict future exposure and dosing can be adapted accordingly. The dictum of “one dose fits all” has been shown problematic for anti infective drugs in critically ill patients, where pathophysiological conditions associated with sepsis result in underexposure.Using real-world data, the applicant will develop popPK models to characterize the relationship between anti infectives dosws and exposure and to investigate dose optimization opportunities for

1. children receiving posaconazole prophylaxis against invasive fungal infections

2. critically ill patients with influenza on posaconazole to prevent invasive aspergillosis

3. critically ill patinets on anidulafungin

4. critically ill patinets on caspofungin

5. women undergoing natural delivery being administered cefazoline 

6. a pooled triazole popPK analysis will be performed (posa-, flu-, isavu-, and voriconazole), aiming to improve predictability of PK, while accounting for inter-drug variability

Date:1 Oct 2020 →  Today
Keywords:Therapeutic drug monitoring, Population pharmacokinetics, Pharmacometrics, Antimicrobials, Antibiotics, Pharmacokinetics, Modeling, Critically ill
Disciplines:Pharmogenetics and -genomics, Biopharmaceutics, Non-clinical studies
Project type:PhD project