FDA SEND Dataset Requirements for Nonclinical Studies
https://www.certara.com/white-paper/fda-send-dataset-requirements-for-nonclinical-studies/
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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/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/
How to Navigate the FDA Landscape for an Orphan Drug
Rare diseases are a public health priority. 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/
FDA 제출 SEND dataset 검토를 위한 QC 고려사항 및 모범사례
FDA 지침에 따라 SEND 데이터셋은 비임상 독성학 연구의 검토와 분석 및 해석에 필수적인 요소이며, 이러한 요구 조건은 앞으로 강화될 것으로 보입니다. 그러나 SEND 데이터셋 프로세스는 작업자가 복잡하고 잦은 데이터 통합 작업 및 반복적인 업무를 진행해야 합니다. 이러한 과정에서 잘못된 데이터 가공, 규제요건 불일치 등의 문제는 FDA 제출과정에 큰 어려움 및 위험을 발생시킬 수 있습니다. 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/