A study on pharmacokinetics of bosentan with systems modeling, Part 2: prospectively predicting systemic and liver exposure in healthy subjects
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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...
متن کاملCorrection 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...
متن کاملA study on pharmacokinetics of bosentan with systems modeling, Part 1: translating systemic plasma concentration to liver exposure in healthy subjects
Systems Modeling and Simulation, Medicine Design, Pfizer Worldwide R&D, Cambridge, MA (RL, DAT, TSM); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Pfizer Worldwide R&D, Groton, CT (MN, NJ, EK, JL, XY, KAR, SR, LMT, LD); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Pfizer Worldwide R&D, Cambridge, MA (AFE). This article has not been copyedited and formatted. The fin...
متن کاملPharmacokinetic 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...
متن کاملMutual pharmacokinetic interactions between bosentan and lopinavir/ritonavir in healthy participants.
BACKGROUND We aimed to investigate the extent of pharmacokinetic drug interactions between bosentan and a fixed combination of lopinavir/ritonavir. METHODS This was a three-way crossover study in 12 healthy male participants treated with bosentan (125 mg twice daily) and lopinavir/ritonavir (400/100 mg twice daily) alone or in combination for 9.5 days. RESULTS Combination treatment resulted...
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تاریخ انتشار 2018