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Year: 2015

Understanding the Relationship Between Systemic and Hepatic Exposure of Obeticholic Acid for the Treatment of Liver Disease in Patients with Cirrhosis

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Obeticholic acid (OCA) is a selective and potent farnesoid X receptor (FXR) agonist in development for several chronic liver diseases. OCA is a semi-synthetic analogue of chenodeoxycholic acid (CDCA) with similar pharmacokinetic (PK) properties. There was a significant increase in systemic exposure of OCA in patients with hepatic impairment. A proportionally similar increase in systemic … Continued

Using Modeling and Simulation to Optimize Dosing of an Anti-infective for Children

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Pediatric drug development can, in many ways, be described as a “Catch 22.” It is extremely challenging (both logistically and ethically) to enroll children in clinical trials, yet without a proper and approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children. Modeling and simulation methods, including population PK modeling, are … Continued

Postcards from the Road: Phoenix Fall Tour

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We’ve just returned from the third leg of our now annual Phoenix roadshow. In this leg, I helped deliver workshops in Beijing, Osaka and Tokyo. In total, our product development team has visited eight cities in the US, Europe and Asia.  We gave both technical and scientific PK/PD modeling presentations to more than 250 clients. … Continued

9 Frequently Misunderstood Concepts in PK/PD Modeling

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In teaching pharmacometrics, I’ve noticed that scientists have difficulty with certain PK/PD modeling concepts. Maybe you’ve read about some of these terms in journal articles, but didn’t know what they meant? Or you’ve heard these terms bandied about by colleagues, but felt too shy to ask them what they meant? I’ll clarify some important concepts … Continued

FDA Equips its Pharmacometrics Teams with Certara’s Phoenix Software

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Partnership provides pharmacometric biosimulation solutions for multiple FDA centers PRINCETON, NJ – Nov. 2, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that the United States Food and Drug Administration (FDA) has outfitted its pharmacometrics teams with Certara’s Phoenix® software. Phoenix is the industry’s premier software platform for managing, analyzing and reporting … Continued

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

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Bioavailability of orally administered drugs can be influenced by a number of factors including release from the formulation, dissolution, stability in the gastrointestinal (GI) environment, permeability through the gut wall and first-pass gut wall and hepatic metabolism. Although there are various enzymes in the gut wall which may contribute to gut first pass metabolism, Cytochrome … Continued

Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects

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Tramadol is frequently used in geriatric patients; however, pharmacokinetic (PK) publications on tramadol and O-desmethyltramadol (ODM) in elderly patients are rare. Our objective was to characterize the PK of tramadol and ODM, including absorption processes and covariates for tramadol, in elderly and young subjects after single-dose administration of 200-mg extended-release tablets. We conducted a PK … Continued

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