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

Poster

PBPK Application in Drug Discovery and Development

Real-World Application of Physiologically Based Pharmacokinetic Modeling (PBPK) in Support of Decision-Making During Drug Discovery;…

Certara2023 年 9 月 20 日

Blog

Top Lessons Learned from 300 Regulatory Submissions

Who would have thought when we completed work on the first submission for which we…

Certara2023 年 9 月 20 日

Announcement

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software PRINCETON, N.J.— 2023 年 9 月 19 日…

Certara2023 年 9 月 19 日

Press Release

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Dedicated team of global regulatory experts delivers submissions in increasingly shorter timelines. PRINCETON, NJ –…

Certara2023 年 9 月 19 日

Fact Sheet

Simcyp® Biopharmaceutics Factsheet

提升生物制药、药物制剂与 CMC 专家的“金标准” PBPK 技术

Certara2023 年 9 月 18 日

博客

What is ICER & How Does it Impact the Pharmaceutical Industry?

The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization.…

Certara2023 年 9 月 15 日

Poster

Modelling of the in vitro Biokinetics of Tebufenpyrad for in vivo Dose Estimation

Certara2023 年 9 月 14 日

Press Coverage

Pharma Focus America: Big Data Analytics – A Revolution in the Pharmaceutical Industry

In this panel discussion, our panelists will explore how big data analytics is reshaping drug…

Certara2023 年 9 月 11 日

pre-update

FDA 加速批准肿瘤适应症药物的趋势

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

PBPK Application in Drug Discovery and Development

Top Lessons Learned from 300 Regulatory Submissions

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Simcyp® Biopharmaceutics Factsheet

What is ICER & How Does it Impact the Pharmaceutical Industry?

Modelling of the in vitro Biokinetics of Tebufenpyrad for in vivo Dose Estimation

Pharma Focus America: Big Data Analytics – A Revolution in the Pharmaceutical Industry

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