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
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
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
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
Why Your Regulatory Writers Need eCTD Authoring Templates Blog Why Your Regulatory Writers Need eCTD Authoring Templates If you’ve heard about eCTD authoring template suites before, but you’re not sure what they…Certara2021 年 5 月 14 日
Maximizing Oligonucleotide Therapeutic Development: How They Work Blog Maximizing Oligonucleotide Therapeutic Development: How They Work This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest…Certara2021 年 5 月 7 日
Planning a Health Canada PRCI Compliant Submission Blog Planning a Health Canada PRCI Compliant Submission How to set yourself up for a successful Health Canada PRCI submissionCertara2021 年 4 月 26 日
Simcyp Simulator Impacts 80+ Novel Drugs Blog Simcyp Simulator 影响了超过 80 种新药的开发 250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and…Certara2021 年 3 月 17 日