Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to…
Certara2016年5月12日
Submitting eCTD in Advance of a Milestone Application
While advanced GPS systems and the advent of Big Data analytics are negating some of…
Certara2016年5月10日
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…
Danielle Pillsbury2016年5月4日
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…
Danielle Pillsbury2016年5月1日
A Six-stage Workflow for Robust Application of Systems Pharmacology
Quantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One…
Danielle Pillsbury2016年5月1日
