PURPOSE The benefits of antioxidant micronutrients in slowing progression to advanced stages of age-related macular degeneration (AMD) was supported by the 4/day tablet form investigated in the Age-related Eye Disease Study 1 (AREDS1) and the 2/day softgel form in the Age-related Eye Disease Study 2 (AREDS2). However, the choices of excipient, dosage form, and ingredient chemistry as well as th...

OBJECTIVE To review the basis for the estimated comparative daily dosages of inhaled corticosteroids for children and adults that are presented in the National Heart, Lung, and Blood Institute's Expert Panel Report 3; in addition, the pharmacodynamic and pharmacokinetic basis for potential clinical differences among inhaled corticosteroids is discussed. DATA SOURCES A complete MEDLINE search ...

The achievement of optimal folate status to prevent neural-tube defects, and possibly other diseases, is hindered by the well-recognised incomplete bioavailability of the natural folates found in foods compared with the synthetic vitamin, folic acid. Folate bioavailability from different foods is considered to be dependent on a number of factors, including the food matrix, the intestinal deconj...

Modeling and simulation methods are now commonly used in drug product development and regulatory drug review process. These applications include, but are not limited to: the development of biorelevant specifications, determination of bioequivalence matrixes for modified release products with rapid therapeutic onset, design of in vitro-in vivo correlations in a mechanistic framework, and predict...

Atorvastatin is a lipid-lowering agent, approved for treatment once daily at 10-80 mg doses in adults and at 10-20 mg doses in children aged 10 years or older [15]. Following oral administration, atorvastatin is rapidly absorbed, and maximum plasma concentrations are achieved within 1 to 2 hours. Atorvastatin is extensively metabolized by cytochrome P450 3A4 to active metabolites: orthoand para...

A single-dosed, open-label, randomized two-way crossover design under fasting period with two weeks wash out period was evaluated in 24 subjects. For the analysis of pharmacokinetic properties, the blood samples were drawn taken up to 72 hours after dosing. Plasma concentration of ramipril and ramiprilat were determined using liquid chromatography – tandem mass spectrometry method with TurboIon...

The best bile acid therapy currently available is ursodeoxycholic acid (UDCA), which is a bile salt that both reduces the secretion of cholesterol into bile and increases cholesterol solubility. The aim of this study is to compare pharmacokinetic parameters as well as relative bioavailability of the developed enteric coated tablet of UDCA 300 mg prepared from micronized drug (MCUDCA) with respe...

Ceftiofur sodium administered as a single dose (2.2 mg/kg, IV and SC) resulted in plasma concentrations of active drug similar to those achieved with the approved IM route. By varying dosing intervals after appropriate concentrations are achieved by IV, SC or IM administration should be effective for treatment of bacterial infections caused by susceptible organisms. Therefore, dosage intervals ...

A standard 2x2 crossover design has been widely used in drug clinical trials, but it is not optimal because of some undesirable statistical properties such as the low power to test carry-ov er effect. Higher-order crossov er designs address this defficiency and, theref ore, have drawn more attention recently. Howev er, exact power calculation of higher-order crossov er designs poses difficulity...