FDA SEND Dataset Requirements for Nonclinical Studies
https://www.certara.com.cn/white-paper/fda-send-dataset-requirements-for-nonclinical-studies/
393 个结果
SEND Dataset Services for FDA IND Submissions
Cleansing, mapping, programming and QC of in-scope nonclinical study data are all critical pieces of the regulatory submission process for both FDA Investigational New Drug (IND) Applications and New Drug Applications (NDAs). Certara’s expert biostats programmers provide submission ready CDISC SEND datasets and supporting documentation; these services are often utilized by biopharma companies without dedicated … Continued
https://www.certara.com.cn/services/send-dataset-services-for-fda-ind-submissions/Dual Filing Strategies: How to Jointly Publish Marketing Applications for EMA and FDA
Even if the product is the same, the applications for marketing authorization in Europe and the United States can look very different. This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency. Tips for … Continued
https://www.certara.com.cn/on-demand-webinar/dual-filing-strategies-how-to-jointly-publish-marketing-applications-for-ema-and-fda/示范主文件在与 FDA 共享、接受和交流方面的作用
https://www.certara.com.cn/publication/the-role-of-model-master-files-for-sharing-acceptance-and-communication-with-fda/
如何在 FDA 的监管下开发孤儿药
罕见病是公共卫生领域的优先事项。FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
https://www.certara.com.cn/blog/how-to-navigate-the-fda-landscape-for-an-orphan-drug/Thank You – Attain FDA Label Claims for Kinase Inhibitor Drugs with Simcyp – brochure
How about a free demo of the Simcyp™ PBPK Simulator? Complete the form to book your no-obligation demo of the standard software for Population-based Physiologically Based Modeling and Simulation… and see how better off you could be with Simcyp!
https://www.certara.com.cn/thank-you-attain-fda-label-claims-for-kinase-inhibitor-drugs-with-simcyp-brochure/Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator without the need to run clinical studies
The Simcyp™ Simulator has been used by large pharma and innovative biotech companies to inform, reduce and/or replace clinical studies for 40 Kinase Inhibitor (KI) drugs in the past decade. This 20+ year in silico technology has been accepted by global regulators, not just in oncology, but also inflammatory, rare, neurology and other diseases. While best known for … Continued
https://www.certara.com.cn/attain-fda-label-claims-for-kinase-inhibitor-drugs-with-the-simcyp-simulator-without-the-need-to-run-clinical-studies/第二届 FDA ASCO 年度研讨会 "正确把握剂量 "的主要经验：优化癌症联合疗法中的剂量选择策略
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。患者对靶向疗法的耐受性更好，治疗时间也从数周延长到数年。These improvements in cancer treatment spurred the FDA’s Project Optimus initiative which has altered the criteria used … Continued
https://www.certara.com.cn/blog/key-lessons-from-the-2nd-annual-fda-asco-workshop-on-getting-the-dosage-right-optimizing-dosage-selection-strategies-in-combination-cancer-therapies/FDA’s guidance and recent workshop on food effect supports use of PBPK
https://www.certara.com.cn/brochure/fdas-guidance-and-recent-workshop-on-food-effect-supports-use-of-pbpk/
The best practice to ensure your SEND dataset submission to FDA [Korean Webinar]
SEND datasets have become an integral part of the review, analysis, and interpretation of nonclinical toxicology studies as per FDA guidance and the needs and trend will only continue to grow. The SEND dataset creation process is challenging and often requires a combination of data integration and manual effort. The quality control process is critically … Continued
https://www.certara.com.cn/on-demand-webinar/the-best-practice-to-ensure-your-send-dataset-submission-to-fda-korean-webinar/
