Using Modeling and Simulation to Quantify the PK of an Anti-HIV Drug for Babies
As a scientist at Certara and proud Dad to my three kids, pediatric drug development…
Certara2015年1月15日
FDA DataFit: an introduction
Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays,…
Certara2014年8月19日
FDA JumpStart: an introduction
Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…
Certara2014年7月16日
Understanding LC/MS/MS
The most common bioanalytical method in use today is LC/MS/MS, or liquid chromatography (LC) tandem…
Certara2014年7月15日
What Can We Learn from Dose Normalization?
Dose normalization is a common calculation performed with pharmacokinetic parameters. The general process is to…
Certara2014年5月19日
Hyperlinking: Making the Most of Navigation in eCTD Submissions
When authors generate documents intended for electronic submission they use blue-colored font to indicate where…
Certara2014年2月5日
What is GLP (Good Laboratory Practice)?
Good laboratory practice or GLP is a set of principles intended to assure the quality…
Certara2013年12月9日
Understanding Steady State Pharmacokinetics
“Steady state” is an important term in pharmacokinetics, but it can often seem a bit…
Certara2013年11月25日
Mean Residence Time (MRT): Understanding How Long Drug Molecules Stay in the Body
When I first began learning about pharmacokinetics, I was often confused by the mean residence…
Certara2013年3月28日
What is a Loading Dose?
Drug therapy in chronic disease situations requires systemic drug levels to reach target steady-state levels…
Certara2013年3月22日
