Blog Archives

Blog

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S)…

CertaraApril 23, 2015

Blog Knowledge Base

Calculating the Elimination Rate Constant

The elimination rate constant is the rate at which drug is cleared from the body…

CertaraFebruary 2, 2015

Blog

Common Misconceptions About Computer System Validation

Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and…

CertaraJanuary 28, 2015

Blog

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…

CertaraJanuary 15, 2015

Blog

FDA DataFit: an introduction

Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays,…

CertaraAugust 19, 2014

Blog

FDA JumpStart: an introduction

Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…

CertaraJuly 16, 2014

Blog Knowledge Base

Understanding LC/MS/MS

The most common bioanalytical method in use today is LC/MS/MS, or liquid chromatography (LC) tandem…

CertaraJuly 15, 2014

Blog Knowledge Base

What Can We Learn from Dose Normalization?

Dose normalization is a common calculation performed with pharmacokinetic parameters. The general process is to…

CertaraMay 19, 2014

Blog

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…

CertaraFebruary 5, 2014

Blog Knowledge Base

What is GLP (Good Laboratory Practice)?

Good laboratory practice or GLP is a set of principles intended to assure the quality…

CertaraDecember 9, 2013

Blog

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

Calculating the Elimination Rate Constant

Common Misconceptions About Computer System Validation

Using Modeling and Simulation to Quantify the PK of an Anti-HIV Drug for Babies

FDA DataFit: an introduction

FDA JumpStart: an introduction

Understanding LC/MS/MS

What Can We Learn from Dose Normalization?

Hyperlinking: Making the Most of Navigation in eCTD Submissions

What is GLP (Good Laboratory Practice)?

Newsletter sign up

Quick links

Solutions

Contact