A study on pharmacokinetics of bosentan with systems modeling, Part 1: translating systemic plasma concentration to liver exposure in healthy subjects

Correction to "A Study on Pharmacokinetics of Bosentan with Systems Modeling, Part 1: Translating Systemic Plasma Concentration to Liver Exposure in Healthy Subjects".

Understanding liver exposure of hepatic transporter substrates in clinical studies is often critical, as it typically governs pharmacodynamics, drug-drug interactions, and toxicity for certain drugs. However, this is a challenging task since there is currently no easy method to directly measure drug concentration in the human liver. Using bosentan as an example, we demonstrate a new approach to...

A study on pharmacokinetics of bosentan with systems modeling, Part 2: prospectively predicting systemic and liver exposure in healthy subjects

Correction to "A Study on Pharmacokinetics of Bosentan with Systems Modeling, Part 2: Prospectively Predicting Systemic and Liver Exposure in Healthy Subjects".

Predicting human pharmacokinetics of novel compounds is a critical step in drug discovery and clinical study design but continues to be a challenging task for hepatic transporter substrates, particularly in predicting their liver exposures. In this study, using bosentan as an example, we prospectively predicted systemic exposure and the (pseudo) steady-state unbound liver-to-unbound plasma rati...

Pharmacokinetic and clinical profile of a novel formulation of bosentan in children with pulmonary arterial hypertension: the FUTURE-1 study

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Exposure to bosentan was lower in paediatric pulmonary arterial hypertension (PAH) patients treated with the marketed adult formulation at a dose of about 2 mg kg(-1) when compared with adult PAH patients. * In healthy adult subjects, bosentan pharmacokinetics are less than dose-proportional at doses of >or=500 mg. WHAT THIS STUDY ADDS * The pharmaco...

Pharmacokinetics and Bioavailability Comparison of two oral Tablet Formulations of Escitalopram 20 mg: A Single-Dose, Open-Label, Two-Period Crossover Study in Healthy Indian Adult Subjects

This study was done to assess bioequivalence between test and reference formulations of escitalopram oxalate 20 mg in healthy Indian male subjects. This single-dose, randomized, open-label, 2-period crossover study was carried out in 12 Healthy Indian Male volunteers aged 18 to 55 years under fasting conditions with a wash out of 14 days.  The subjects were randomly assigned to receive the test...