Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success Blog Post
抗体-药物偶联物（Antibody-Drug Conjugate，ADC）是一种清除肿瘤细胞的独特方法，也是肿瘤学领域一种未得到充分利用的免疫疗法，无论是作为单一疗法还是联合疗法。The first FDA approval…
Incorporating the patient voice into clinical trial summaries Page
Certara 提供符合 EMA/UK 监管的简明语言文档，含可定制模板、信息图及易理解设计，优化临床试验沟通。
Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations Blog Post
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK)…
Complex patient profile and narrative template needs Blog Post
某全球药企委托 Certara 为其高复杂性研究设计患者档案（PPL）与叙述模板。在过去，PPL均由申办方的统计编程团队完成 ，以作为审核者在审核环节中使用的资源，但今后这种方式将无法被继续采用。...
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog Post
Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage…
Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers Blog Post
This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence and Value Communications Symposium. This session featured the following four speakers: Shawn W. Bates is…
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Blog Post
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on 2021 年 4 月 15 日 was not any different. The agenda…
