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FDA Trends for Accelerated Drug Approvals in Oncology Indications

The FDA has modified and increased expectations around data needed to support accelerated approvals in oncology Unlike prior trends, randomized controlled trials will be the preferred approach to support an application for accelerated approval moving forward the acceptability of single arm trials for accelerated approval will receive significant scrutiny Prolonged duration on the market for … Continued

https://www.certara.com.cn/poster/fda-trends-for-accelerated-drug-approvals-in-oncology-indications/

Certara Simcyp™ Group Awarded Two New Grants from US FDA

Programs focus on use of physiologically-based pharmacokinetic (PBPK) modeling for demonstrating virtual bioequivalence and predicting drug absorption of topical formulations PRINCETON, N.J.— 2023 年 8 月 29 日– Certara (Nasdaq: CERT), a global leader in biosimulation, today announced that the Simcyp group has been awarded two new grants from the U.S. Food and Drug Administration (FDA) to expand its … Continued

https://www.certara.com.cn/pressrelease/certara-simcyp-group-awarded-two-new-grants-from-us-fda/

Certara 与韩国毒物学研究所合作，确保 SEND 数据集可供 FDA 提交使用

Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines. Seoul, SOUTH KOREA August 4rd – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical … Continued

https://www.certara.com.cn/announcement/certara-collaborates-with-korea-institute-of-toxicology-to-ensure-fda-submission-ready-send-dataset/

AAPS eChalk talk: FDA Modernization Act — 对制药科学家意味着什么？

Historically, the FDA has required drug discovery and development programs to include animal testing. With the 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical development has been broadened to include adjunct and complementary testing methods. In this webinar with Certara’s Dr. Jim Herman, he will discuss how scientists can use innovative, … Continued

https://www.certara.com.cn/on-demand-webinar/aaps-echalk-talk-fda-modernization-act-what-does-it-mean-for-pharmaceutical-scientists/

了解 FDA 现代化法案 2.0 对药物开发的影响

了解 FDA 现代化法案 2.0 将如何通过允许动物试验的替代方法来改变药物研发格局。

https://www.certara.com.cn/white-paper/understanding-the-impact-of-fda-modernization-act-2-0-on-drug-development/

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus. Reprinted with permission from Applied Clinical Trials. Applied Clinical Trials is a copyrighted publication of MultiMedia Healthcare, LLC. 保留所有权利。

https://www.certara.com.cn/article/fdas-project-optimus-guidance-highlights-and-tips-for-success-for-oncology-drug-developers/

Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year

Asserts Certara’s leadership in advancing the development and approval of new drugs for patients PRINCETON, N.J.— 2023 年 4 月 27 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received … Continued

https://www.certara.com.cn/pressrelease/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year/

By Eliminating Requirement for Animal Testing, FDA Modernization Act Allows Faster, More Cost-effective Drug Development

By easing regulatory requirements for animal testing, the Act allows scientists to use innovative, leading-edge technologies more fully in future drug development strategies.

https://www.certara.com.cn/article/by-eliminating-requirement-for-animal-testing-fda-modernization-act-allows-faster-more-cost-effective-drug-development/

关于 FDA Project Optimus，您应该了解哪些有关肿瘤药物审批的信息

一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。这导致药物的药代动力学（PK）特征、药代动力学/药效学（PK/PD）关系以及临床靶点抑制作用在很大程度上被忽视。Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many … Continued

https://www.certara.com.cn/on-demand-webinar/what-you-should-know-about-fda-project-optimus-for-your-oncology-drug-approval/

FDA Modernization Act 2.0 — 它对药品开发人员意味着什么？

Historically, the FDA has required drug discovery and development programs to include animal testing. This requirement has ended with the 2022 passage of the FDA Modernization Act. This change has opened the door for expanded use of alternatives to animal testing including biosimulation, organ-on-a-chip, and cell based assays. In this panel discussion with Nasdaq’s David … Continued

https://www.certara.com.cn/on-demand-webinar/fda-modernization-act-2-0-what-does-it-mean-for-drug-developers/

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