FDA guideline on Population Pharmacokinetics.

PERSPECTIVE FDA Withdraws LAL Test Guideline

On June 22, 2011, the U.S. Food and Drug Administration (FDA) withdrew the “Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-product Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices,” which was issued in 1987. Elements of the Guideline continue to impact current methods because they can be found in other references relied on by the indus...

Population pharmacokinetics of omeprazole in a random Iranian population

Background: Omeprazole is metabolized predominantly by CYP2C19, a polymorphically expressed enzymes that show marked interindividual and interethnic variation. These variations cause a substantial differences that have been reported in the pharmacokinetics of omeprazole. The aim of the present study was to evaluate the pharmacokinetic parameters of omeprazole in a random Iranian population. Met...

Pharmacokinetics in pediatric population

Population Pharmacokinetics -- final

Population pharmacokinetics of exenatide

AIM The aim of the present analysis was to develop a core population pharmacokinetic model for the pharmacokinetic properties of immediate-release (IR) exenatide, which can be used in subsequent analyses of novel sustained-release formulations. METHODS Data from eight clinical trials, evaluating a wide range of doses and different administration routes, were available for analysis. All modell...