Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program Blog Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help…Certara2021 年 7 月 21 日
What is BaseCase? 视频 What is BaseCase? Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…Certara2021 年 7 月 20 日
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate On-Demand Webinar 开源建模工具:火上浇油 vs. 平息争论 The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…Jim Gallagher2021 年 7 月 15 日
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success Blog 确保抗体-药物偶联物开发最大概率获得成功的关键考虑事项 Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…Certara2021 年 7 月 8 日
Meet a Certara regulatory operations specialist Video 会见 Certara 监管运营专家 Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares…Certara2021 年 7 月 2 日
Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations Blog Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics.…Certara2021 年 6 月 25 日
Fundamentals of regulatory writing: the document development process Article Fundamentals of regulatory writing: the document development process Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…Certara2021 年 6 月 22 日
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog 将 Simcyp PBPK Simulator 集成到药物开发程序中的主要 10 益处 Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…Certara2021 年 6 月 22 日
Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers Blog Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence…Certara2021 年 6 月 18 日
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Blog Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory…Certara2021 年 6 月 15 日