Modeling and Simulations in Latin-American Generic Markets: Perspectives from Chilean Local Industry, Regulatory Agency, and Academia.

In the last 20 years, modeling and simulations (M&S) have gained increased attention in pharmaceutical sciences. International industry and world-reference agencies have used M&S to make cost-efficient decisions through the model-informed drug development (MIDD) framework. Modeling tools include biopredictive dissolution models, physiologically based pharmacokinetic models (PBPK), biopharmaceutic models (PBBM), and virtual bioequivalence, among many others.

Population pharmacokinetics of amikacin in suspected cases of neonatal sepsis.

Aims: This study aimed to characterize the population pharmacokinetic parameters of intravenously administered amikacin in newborns and assess the effect of sepsis in amikacin exposure.

Methods: Newborns aged ≥3 days who received at least 1 dose of amikacin during their hospitalization period were eligible for the study. Amikacin was administered intravenously during a 60-min infusion period.

Determination of prednisolone and prednisone in plasma, whole blood, urine, and bound-to-plasma proteins by high-performance liquid chromatography.

A high-performance liquid chromatographic technique for the simultaneous determination of prednisolone and prednisone in human plasma, whole blood, urine, and bound-to-plasma proteins, using betamethasone as internal standard, is presented. Liquid-liquid extraction is used for whole blood samples, and solid phase extraction is used for plasma, urine, and proteins bound to plasma. The accuracy, precision, specificity, linearity, and repeatability meet the requirements of current recommendations in bioanalytical method validation.

Impact of a pharmaceutical care program in a community pharmacy on patients with dyslipidemia.

Background: Inappropriate use of medications is a significant problem in health care today. A possible solution to this problem may be achieved through better control of patients' drug therapy.

Objective: To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications, while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life.