Projects

Background and rationale: Pharmacometrics (mixed effects) modelling and simulation is increasingly used to characterise, understand, and predict the dose-exposure-response relationships of drugs. Consequently, model-informed drug development (MIDD) has become an established business value, facilitating a cost-efficient drug development process. Population-level dosing is the preferred dosage strategy, followed by group-level dosing ...

In clinical drug development, “one dose fits all” is a key objective. However, variability in exposure and thus response 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 exposure target by guiding individualised drug dosing based upon drug concentrations. “Population ...

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 ...

In clinical drug development, “one dose fits all” is a key objective. However, variability in exposure (E) and response (R) is common and can result in suboptimal treatment of individual patients. To hit a predefined E/R target in each patient, “therapeutic drug monitoring” or TDM is often implemented. TDM helps improving attainment of a desired E/R target by guiding individualised drug dosing based upon drug concentrations. “Population ...

Inflammatory bowel diseases (IBD) are chronic, relapsing, inflammatory conditions of the gastrointestinal (GI) tract. Ulcerative colitis (UC) and Crohn’s disease (CD) are the primary subtypes of IBD. Although the etiology remains incompletely understood, it is generally accepted that IBD is the result of an inappropriate host response to environmental factors in genetically susceptible individuals. In Western Europe, prevalence of UC is ...

Crohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD). Approximately 2.2 million patients suffer from these incurable disabling diseases in Europe. State-of-the-art anti-tumour necrosis factor (TNF) alpha treatment (e.g. infliximab, adalimumab) is increasingly used throughout the disease course to induce and maintain clinical remission in IBD patients. Notwithstanding these drugs are very efficacious; nearly 40% ...