Novel approach to bioequivalence assessment based on physiologically motivated model.

The study was conducted to exemplify an approach capable of obtaining a new insight into bioequivalence (BE) assessment, by the use of a physiologically motivated model. Data from an oral BE study of two piroxicam (PXM) products was used as an example. The BE study was carried out with 24 healthy European subjects according to a two-sequence crossover-randomized design.

Computer controlled sequential simulation method: reconsidering evaluation of measurements from frequently sampled intravenous glucose tolerance test.

This work describes quantification of regulatory mechanisms glucose-insulin, using data from a frequently sampled intravenous glucose tolerance test (FSIVGTT) and a mechanistically motivated model with time delays. FSIVGTT was performed on 14 young healthy volunteers. The constructed model computationally takes into account the form of the short-time glucose infusion used.

Physiologically motivated time-delay model to account for mechanisms underlying enterohepatic circulation of piroxicam in human beings.

The study was conducted to formulate a physiologically motivated time-delay (PM TD) mathematical model for human beings, which incorporates disintegration of a drug formulation, dissolution, discontinuous gastric emptying and enterohepatic circulation (EHC) of a drug. Piroxicam, administered to 24 European, healthy individuals in 20 mg capsules Feldene Pfizer, was used as a model drug. Plasma was analysed for piroxicam by a validated high-performance liquid chromatography method.

Long-term follow-up of renal function in patients after surgery for obstructive uropathy.

In this prospective study, selected biochemical markers of glomerular and tubular function, proteinuria, and ultrasound findings in 62 pediatric patients who underwent surgery for obstructive uropathy were examined. Patients were younger than 12 months, normocreatininemic at the time of surgery, and examined at a mean age of 6.3+/-0.

Estimation of influence of gastric emptying on shape of glucose concentration-time profile measured in oral glucose tolerance test.

Aims: To develop a model for simulations of processes in the oral glucose tolerance test (OGTT), using tools of the theory of dynamic systems.

Methods: Frequent sampling OGTT was performed in 13 healthy subjects (6 males and 7 females). Subsequently, employing glucose and insulin concentration-time profiles of the subjects, the model was developed.

Etiology and epidemiology of end-stage renal disease in Dutch children 1987-2001.

In this retrospective study 351 children (<16.0 years) with end-stage renal disease (ESRD) accepted for renal replacement therapy (RRT) in the four Dutch pediatric centers were analyzed for the period 1987-2001. The data were compared with a previous study performed in 1979-1986.