The absorption of oral drugs is frequently plagued by significant variability with potentially
serious therapeutic consequences. The source of variability can be traced back to …

Many lead compounds fail to reach clinical trials despite being potent because of low
bioavailability attributed to their insufficient solubility making solubility a primary and crucial …

Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

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 …

Many drugs are still prescribed off‐label to the pediatric population. Although off‐label drug
use not supported by high level of evidence is potentially harmful, a comprehensive …

Introduction Drug delivery systems with extended-release profiles are ideal in improving
patient compliance with enhanced efficacy. To develop devices capable of a prolonged …

Selecting the appropriate formulation and solubility-enabling technology for poorly water
soluble drugs is an essential element in the development of formulations for paediatric …

Despite much progress in regulations to improve paediatric drug development, there
remains a significant need to develop better medications for children. For the design of oral …

OBJECTIVES The safe use of medications in pediatric patients requires practitioners to
consider the unique pharmacokinetics and pharmacodynamics of drugs prescribed in this …

A drug is granted a license for use after a thorough assessment of risks and benefits based
on high‐quality scientific proof of its efficacy and safety. Many drugs that are relevant to …