The effect of plasmapheresis on blood pressure in voluntary plasma donors

Donor plasmapheresis involves the removal of a weight-adjusted volume of plasma and the return of cellular components to the donor. Although plasma volume generally returns to normal, some residual effect on vital signs may be possible. This analysis was performed to determine the possible effects of plasmapheresis on blood pressure. A 16-week study was conducted […]

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Pharmacokinetics of Injectable, Long-acting Nevirapine for HIV Prophylaxis in Breastfeeding Infants.

Mother-to-child transmission (MTCT) of HIV-1 remains a global health problem. The World Health Organization (WHO recommendations advise the administration of a once-daily, oral, prophylactic regimen of the nonnucleoside reverse transcriptase inhibitor nevirapine (NVP) from birth until four to six weeks of age for infants born to HIV-infected mothers in regions without access to safe and […]

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Automated Prediction of First In Man Dosing Using Pre Clinical PK Data

Humans differ from commonly used pre-clinical model organisms (rats, dogs, monkeys) in terms of their biochemistry, physiology, and anatomy. Predicting a drug’s pharmacokinetic (PK) profile in humans using animal PK data must account for these differences. Allometric scaling is used to predict human PK parameters based on animal data. While allometric scaling has been used […]

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Using Modeling & Simulation to Optimize Dosing of an Anti-Infective for Children

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. Biosimulation methods, including population PK modeling, are reshaping the […]

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Population Analysis of Complex Multidimensional Responses using Phoenix NLME

During this webinar, Dr. Serge Guzy demonstrated how Phoenix NLME’s unique interface facilitates a whole new way of thinking about Pop PK/PD that is well-suited to both beginning and advanced modelers. He also highlighted Phoenix NLME’s robust optimization engines, including the recent updates to the QRPEM engine. The webinar showed how easy Phoenix NLME makes […]

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A student’s perspective on using Phoenix NLME for popPK analysis of an intranasal combination drug

The pharmacokinetic dispositions and the underlying variability of Kovacaine Mist®, a combination product containing oxymetazoline and tetracaine, were investigated by nonlinear mixed effects modeling using Phoenix® NLME. The project utilized the different plugins in the Phoenix® platform allowing all steps of model development right from data setup to producing publication quality graphs in a single […]

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