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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/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/pressrelease/certara-simcyp-group-awarded-two-new-grants-from-us-fda/

Korea Institute of Toxicology 、FDA申請可能なSENDデータセット作成のためサターラと協力

グローバルガイドラインに沿って前臨床試験データ管理を最適化するのに役立つソフトウェアの導入Seoul, SOUTH KOREA August 4rd –  Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) は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/announcement/certara-collaborates-with-korea-institute-of-toxicology-to-ensure-fda-submission-ready-send-dataset/

AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?

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/on-demand-webinar/aaps-echalk-talk-fda-modernization-act-what-does-it-mean-for-pharmaceutical-scientists/

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. 無断複写・転載を禁じます

https://www.certara.com/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. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) は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/pressrelease/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year/

What you should know about FDA Project Optimus for your oncology drug approval

歴史的に、がん治療薬の投与戦略は最大耐容量に焦点が当てられてきました。そのため、薬剤の薬物動態（PK）プロファイル、薬物動態/薬力学（PK/PD）関係、臨床標的の阻害などがほとんど無視された状態になっています。そのため、がん患者は長期間の薬物投与に耐えられないことが多く、減量や休薬などの用量変更を余儀なくされています。What’s more, for many … Continued

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

FDA Modernization Act2.0：創薬研究者はどこに注目すべきか？

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/on-demand-webinar/fda-modernization-act-2-0-what-does-it-mean-for-drug-developers/
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