The Role of a U.S. Agent
Foreign sponsors of drug applications who want to conduct business in the United States need…
CertaraSeptember 6, 2016
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
