Press Coverage

How Modeling Can Help to Improve Children’s Access to Properly Evaluated Medications

Regulatory guidance paves the way to address ethical concerns in pediatric trials, and how additional…

Certara2023 年 10 月 5 日

On-Demand Webinar

Clinical Pharmacology Issues That Can Lead to Approvability Problems for Your Drug

临床药理信息占药品说明书的 50% 以上。Inadequate clinical pharmacology development…

Certara2023 年 10 月 4 日

Announcement

Certara Launches CoAuthor, a Regulatory and Medical Writing Tool

Using AI to gain efficiencies for medical writers PRINCETON, N. J.— 2023 年 10 月 3 日— Certara,…

Certara2023 年 10 月 3 日

On-Demand Webinar

Unlocking ROI through Omnichannel Stakeholder Engagement and Value Communication in Pharma

In a sector where both competition and stakeholder expectations are high, a comprehensive approach that…

Certara2023 年 10 月 2 日

Blog

开发针对不同种族群体的儿科 PBPK 模型

Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because…

Certara2023 年 9 月 29 日

Press Coverage

What recent paediatric guidelines mean for drug developers

Justin Hay, Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs…

Certara2023 年 9 月 25 日

Conference

2024 KIC: KoNECT-MOHW-MFDS International Conference

Certara2023 年 9 月 22 日

Blog

Maximizing reusability for drug submissions to different health authorities

Many drug developers have products that they want to submit for marketing approval in several…

Certara2023 年 9 月 21 日

Poster

FDA 加速批准肿瘤适应症药物的趋势

The FDA has modified and increased expectations around data needed to support accelerated approvals in…

Certara2023 年 9 月 20 日

Poster

肿瘤药物早期临床试验中患者报告结局（PROs）的采用：挑战与机遇

Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…

Certara2023 年 9 月 20 日

pre-update