Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator Blog Post
Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies for 40 Kinase Inhibitor (KI) drugs.
Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies Blog Post
癌症治疗已从一般细胞毒性疗法发展为针对癌细胞中特定通路和变异的药物。Patients tolerate targeted therapies better, and their treatment continues over a…
FDA Trends for Accelerated Drug Approvals in Oncology Indications Blog Post
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…
Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset Blog Post
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…
AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists? Blog Post
历史上，FDA 要求药物发现与开发项目必须包含动物试验。With the 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical…
Understanding the Impact of FDA Modernization Act 2.0 on Drug Development Blog Post
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。
FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers Blog Post
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…
What you should know about FDA Project Optimus for your oncology drug approval Blog Post
一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely…
FDA Modernization Act 2.0 — 它对药品开发人员意味着什么？ Blog Post
历史上，FDA 要求药物发现与开发项目必须包含动物试验。这一要求已随 2022 年 FDA Modernization Act 的通过而终止。This change has…
FDA awards new grants to support developing & assessing complex generic drugs Blog Post
Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) of complex generic drugs PRINCETON, N.J.— 2023 年 2 月 7 日. Certara…
