Data Visualization with SEND Data to See What Happened at the Preclinical Phase
SEND is an implementation of CDISC’s (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation…
Certara2023 年 2 月 9 日
The eCTD Submission Process: Tips and Tricks for Drug Development Success
Our experts compiled the tips and best practices you need to know for a successful…
Certara2022 年 11 月 22 日
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…
Certara2022 年 6 月 3 日
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
