PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA
In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…
Certara2022年6月2日
P21 Adds Support for CDISC Open Rules Engine (CORE)
P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available…
Certara2022年4月25日
Pinnacle 21 Releases P21 Community 4.0
As of 2022年4月25日, we have released P21 Community 4.0 to general availability! Install…
Certara2022年4月25日
PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials
Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…
Certara2022年4月11日
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
