Rare Disease and Orphan Drug Development
There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…
CertaraAugust 3, 2016
Assessing Drug-Smoking Interactions Using PBPK Modeling
The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn't…
CertaraJuly 29, 2016
How to Prepare a Study Data Standardization Plan (SDSP) for FDA
Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…
CertaraJuly 25, 2016
Model-based Meta-analysis: An Innovative Methodology Comes of Age
MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…
CertaraJuly 14, 2016
Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment
Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime…
CertaraJuly 12, 2016
A Tutorial on Pharmacodynamic Scripting Facility in Simcyp
The Simcyp® Simulator provides a framework for mechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic modelling of potentially interacting drugs.…
CertaraJuly 9, 2016
Status of QSP Modeling in the Pharmaceutical Industry
A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…
CertaraJuly 6, 2016
