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
