Introduction Obesity is associated with many physiological changes. We review available
evidence regarding five commonly accepted assumptions to a priori predict the impact of …

Pediatric drug development faces many difficulties. Traditionally, pediatric drug doses are
simply calculated linearly based on the body weight, age, and body surface area of adults …

Introduction: Obesity is associated with many physiological changes. We review available
evidence regarding five commonly accepted assumptions to a priori predict the impact of …

Capturing ontogeny of enzymes involved in phase I metabolism is crucial to improve
prediction of dose‐concentration and concentration‐effect relationships throughout infancy …

Cytosolic sulfotransferases (SULTs), including SULT1A, SULT1B, SULT1E, and SULT2A
isoforms, play noteworthy roles in xenobiotic and endobiotic metabolism. We quantified the …

Introduction When pediatric data are not available for a drug, allometric and other methods
are applied to scale drug clearance across the pediatric age-range from adult values. This is …

Adopted guidelines reflect a harmonised European approach to a specific scientific issue
and should reflect the most recent scientific knowledge. However, whilst EU regulations are …

Midazolam is metabolized by the developmentally regulated intestinal and hepatic drug‐
metabolizing enzyme cytochrome P450 (CYP) 3A4/5. It is frequently administered orally to …

The challenges of drug development in pediatric, pregnant and geriatric populations are a
worldwide concern shared by regulatory authorities, pharmaceutical companies, and …

Aims Drug disposition in children may vary from adults due to age‐related variation in drug
metabolism. Microdose studies present an innovation to study pharmacokinetics (PK) in …