Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry Case Study 提供全天候监管支持,同时提升团队凝聚力 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 Case Study 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) Announcement 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 Announcement 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 Case Study 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 Announcement 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 Blog 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
Using Real-world Evidence to Advance Market Access for New Therapeutics White Paper 运用真实世界证据推动新疗法市场准入 Certara2021 年 9 月 29 日
The Scary Future of Rare Disease Management On-Demand Webinar 罕见病管理的“可怕”未来 In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…Certara2021 年 9 月 23 日