P21 Releases New PMDA Validation Engine
New PMDA Engine Pinnacle 21 is happy to announce the latest Validation Engine for submissions…
Certara2021 年 12 月 20 日
Industry Metrics for CDISC Controlled Terminology
Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…
Certara2021 年 11 月 17 日
The Scary Future of Rare Disease Management
In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…
Certara2021 年 9 月 23 日
Preparing Vaccine Studies for Regulatory Submissions
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…
Certara2021 年 9 月 10 日
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…
Certara2021 年 9 月 10 日
Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children
Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…
Certara2021 年 8 月 26 日
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs
In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…
Certara2021 年 8 月 26 日
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification
Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…
Certara2021 年 8 月 12 日
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib
Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…
Certara2021 年 8 月 12 日
