Month: 2016年5月
Certara and The University of Manchester Co-host Inaugural Model-based Personalized Drug Dosing in Healthcare Conference
PRINCETON, NJ – 2016年5月25日 – Clinical healthcare researchers, academic, and industry experts from eight countries collaborate to advance the goal of identifying the right drug dose for each patient.
Getting at the HAART of Precision Dosing: Using PBPK Models to Optimize Dosing of an Antiviral
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. It is primarily metabolized by CY2B6. A standard dose of efavirenz has been associated with serious adverse reactions in poor metabolizers (PMs) of CYP2B6, necessitating a reduction … Continued
The Evolving Landscape of Drug Development in China
Pharma innovation will continue to increase in China as product differentiation grows in importance. As a result, the percent of generics on the Chinese market will continue to decrease and the number of novel new drug applications will increase.
Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an approved (ie, reference) drug in their rate and extent of absorption. The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under … Continued
Dr. Adam Darwich is Appointed Certara Lecturer in Precision Dosing at The University of Manchester, England
PRINCETON, NJ – 2016年5月12日 – This new role for Adam Darwich, PhD, furthers Certara’s mission to bring individual patient dosing into mainstream clinical care.
Submitting eCTD in Advance of a Milestone Application
While advanced GPS systems and the advent of Big Data analytics are negating some of their advantages, early birds are still capturing worms at a good clip. We’ve heard this slogan since childhood. For those of you planning to implement eCTD, the early bird’s experience rings true. Many people erroneously believe that your first eCTD … Continued
Can QSP Save Lives? Lessons from the Bial Trial Debacle
One of the biggest challenges for the pharmaceutical industry is the high rate of drug attrition in Phase 2 clinical trials, which wastes significant amounts of money and time. The major reasons for this attrition are that either candidate drugs do not show efficacy or have unexpected toxicity, in turn implying that we did not fully understand the complexity of the biology the candidate drugs were designed to modulate.
Developing an Adaptive Trial Design that Accounts for Rapidly Changing Pediatric Physiology
In this webinar, we discussed a population pharmacokinetic modeling and simulation approach to design a raltegravir dosing regimen for the prevention or treatment of HIV in newborns up to 6 weeks of age.
Optimization of Vancomycin Dosing Regimens to Achieve Therapeutic Targets in Critically Ill Patients in Thailand
It is essential to rapidly achieve therapeutic vancomycin concentrations in critically ill patients with gram-positive bacterial infections. This study aimed to determine optimal vancomycin dosing regimens for critically ill patients. Using an external dataset – therapeutic drug monitoring concentration data from 51 critically ill patients receiving vancomycin, we validated a population pharmacokinetic model to describe … Continued
