Common Clinical Trial Disclosure Challenges & Potential Solutions Blog Common Clinical Trial Disclosure Challenges & Potential Solutions Pharmaceutical companies are being required to be more transparent through the timely disclosure of more…Certara2023 年 2 月 24 日
FDA Modernization Act 2.0 — 它对药品开发人员意味着什么? 网络研讨会点播 FDA Modernization Act 2.0 — 它对药品开发人员意味着什么? 历史上,FDA 要求药物发现与开发项目必须包含动物试验。This…Danielle Pillsbury2023 年 2 月 21 日
RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act On-Demand Webinar RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act The Inflation Reduction Act (enacted in August 2022) contains profound changes for the healthcare and…Danielle Pillsbury2023 年 2 月 10 日
Data Visualization with SEND Data to See What Happened at the Preclinical Phase On-Demand Webinar 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…Danielle Pillsbury2023 年 2 月 9 日
A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit White Paper A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit Jim Gallagher2023 年 2 月 8 日
Podcast interview with Dr. Elvira Müller. EU joint HTA – decided, but how will it be executed and how should companies prepare Podcast Podcast 采访 Dr. Elvira Müller 欧盟联合 HTA - 已决定,但将如何执行,企业应如何准备 In Europe, there are at least as many reimbursement assessment processes in place as European…Danielle Pillsbury2023 年 2 月 7 日
FDA awards new grants to support developing & assessing complex generic drugs Announcement FDA awards new grants to support developing & assessing complex generic drugs Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models…Certara2023 年 2 月 7 日
Artificial Intelligence: What is it & how can it accelerate rare disease drug development? 博客 人工智能:它是什么,以及它如何加速罕见病药物开发? Large & complex information streams present opportunities for the AI data scientist to aid in…Certara2023 年 2 月 3 日
Machine learning model selection with Darwin in Pirana On-Demand Webinar 在 Pirana 中使用 Darwin 选择机器学习模型 探索如何通过 Pirana Darwin 模块优化机器学习模型筛选。Watch this on-demand…Danielle Pillsbury2023 年 2 月 3 日
Certara’s combined PBPK/QSP model predicts safety and efficacy biomarker outcomes in Alzheimer’s Disease, as demonstrated in recent lecanemab work with Eisai White Paper Certara’s combined PBPK/QSP model predicts safety and efficacy biomarker outcomes in Alzheimer’s Disease, as demonstrated in recent lecanemab work with Eisai Jim Gallagher2023 年 2 月 2 日