Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …

Developmental changes in children can affect the disposition and clinical effects of a drug,
indicating that scaling an adult dose simply down per linear weight can potentially lead to …

This commentary provides an update on the status of physiologically based pharmacokinetic
modeling and simulation at the US Food and Drug Administration's Office of Clinical …

The liver represents a major eliminating and detoxifying organ, determining exposure to
endogenous compounds, drugs, and other xenobiotics. Drug transporters (DTs) and drug …

Purpose: The increasing burden of invasive fungal infections results in growing challenges
to antifungal (AF) therapeutic drug monitoring (TDM). This review aims to provide an …

Drugs in solid dispersion (SD) take advantage of fast and extended dissolution, thus attains
a higher bioavailability than the crystal form. However, current development of SD relies on …

The purpose of this review was to assess the advancement of applications for
physiologically based pharmacokinetic (PBPK) modeling in various therapeutic areas. We …

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 …

Interest in determining safe and efficacious doses for drug administration in pediatric
patients has increased dramatically in recent years. However, published pediatric clinical …

Therapeutic hypothermia (TH) is standard treatment for neonates (≥ 36 weeks) with
perinatal asphyxia (PA) and hypoxic–ischemic encephalopathy. TH reduces mortality and …