Month: March 2013
Pharmacokinetic Model to Simulate Oral Drug Bioavailability of Atorvastatin Acid and Cyclosporine Post Bariatric Surgery
Modeling and Simulations to Support Dosing Regimen of a Fixed-dose Combination Product of Immediate-release Phentermine and Modified-release Topiramate (VI-0521) in Patients with Renal Impairment
Modeling and Simulations of a Fixed-dose Combination Product of Immediate-release Phentermine and Modified-release Topiramate (VI-0521) on Heart Rate in Obese Patients
Modeling and Simulations of a Fixed-dose Combination Product of Immediate-release Phentermine and Modified-release Topiramate (VI-0521) to Support Dosing Regimen in Patients with Hepatic Impairment
Development of Sparse Sampling Strategies During First-in-human Oncology Studies: A Potential Approach to Minimize Confinement and Facilitate Enrollment of Cancer Patients
Race and Drug Formulation Influence on Mycophenolic Acid Pharmacokinetics in Stable Renal Transplant Recipients
Limited mycophenolic acid (MPA) data are available comparing racial influence on mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) pharmacokinetics. Intrapatient MPA pharmacokinetics of MMF versus EC-MPS were compared in 13 male African American (AA) and 14 Caucasian (C) renal transplant recipients (RTRs). RTRs were switched to equivalent doses of the alternate formulation for at … Continued
Plasma Topiramate Concentrations from Doses Associated with Neuroprotection Against White Matter Injury and Stroke in Two Strains of Rat Pups
Cerebral white matter (WM) injury and stroke are common neuropathological injuries in newborns with congenital heart defects (CHDs) requiring surgery. Previous investigations in Long Evans rat pups subjected to hypoxia-ischemia found that intraperitoneal (i.p.) topiramate (TPM) at 30 mg/kg, but not 50 mg/kg, conferred neuroprotection. In Sprague-Dawley pups, a dose of 30 mg/kg protected against … Continued
Pharmacokinetic and Pharmacodynamic Modeling to Determine the Human Dose of ST-246(R) to Protect Against Smallpox
Although smallpox has been eradicated, the United States government considers it a “material threat” and has funded the discovery and development of potential therapeutic compounds. As reported here, the human efficacious dose for one of these compounds, ST-246, was determined using efficacy studies in nonhuman primates (NHPs), together with pharmacokinetic and pharmacodynamic analysis that predicted … Continued
In Vitro to Human In Vivo Translation—Pharmacokinetics and Pharmacodynamics of Quinidine
The translational sciences aim to transfer results from basic research to the treatment of animals or patients. One of the approaches that could be utilized to achieve this goal is the in vitro in vivo extrapolation (IVIVE) of pharmacokinetic (PK) and pharmacodynamic (PD) properties using in silico methods. Such methodology, if properly applied, could help substantially … Continued