FDA SEND Dataset Requirements for Nonclinical Studies
https://www.certara.com/white-paper/fda-send-dataset-requirements-for-nonclinical-studies/
393件の検索結果
FDA向けINDデータセット作成支援サービス
非臨床試験データのクレンジング、マッピング、プログラミング、およびQCはすべて、FDAの新臨床試験開始申請（IND）および新薬承認申請（NDA）の規制当局への申請プロセスにおいて重要な要素です。サターラの専門バイオスタッツプログラマーは、提出準備の整った CDISC SEND データセットと付属文書を提供します。つづく...
https://www.certara.com/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/on-demand-webinar/dual-filing-strategies-how-to-jointly-publish-marketing-applications-for-ema-and-fda/The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA
https://www.certara.com/publication/the-role-of-model-master-files-for-sharing-acceptance-and-communication-with-fda/
希少疾病用医薬品のためにFDAの状況をナビゲートする方法
希少疾患は公衆衛生上の優先事項です。FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
https://www.certara.com/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/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/attain-fda-label-claims-for-kinase-inhibitor-drugs-with-the-simcyp-simulator-without-the-need-to-run-clinical-studies/Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies
Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and alterations in cancer cells. Patients tolerate targeted therapies better, and their treatment continues over a period of years, instead of a few weeks. These improvements in cancer treatment spurred the FDA’s Project Optimus initiative which has altered the criteria used … Continued
https://www.certara.com/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/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/on-demand-webinar/the-best-practice-to-ensure-your-send-dataset-submission-to-fda-korean-webinar/