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…Jim Gallagher2022 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
Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3 On-Demand Webinar Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3 On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…Danielle Pillsbury2021 年 12 月 16 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 Jim Gallagher2021 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…Jim Gallagher2021 年 9 月 23 日
Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Case Study 使用 Simcyp Simulator 确定 Guanfacine 在儿童中的药物相互作用风险 Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…Jim Gallagher2021 年 8 月 26 日
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study 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…Jim Gallagher2021 年 8 月 26 日
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…Jim Gallagher2021 年 8 月 12 日