Author: Danielle Pillsbury
利用 QSP 探索 ADC 药代动力学【亚太地区网络研讨会】
The Pharmacokinetics (PK) of ADC therapeutics typically show a discrepancy between the PK of total antibody and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation, however recent evidence suggests that the underlying mechanisms may be more complex. In this webinar, we will present how quantitative systems … Continued
加强法规撰写：样式指南的力量
TranscriptMany pharmaceutical industry professionals once considered standardizing regulatory writing style conventions unnecessary and time-consuming. However, the industry now recognizes its benefits for maximizing efficiency during regulatory submission development. The benefits of using style guides and lexicons in medical writing include: The Certara Drug Development Solutions Document Quality group is experienced in creating and maintaining style guides and … Continued
Molecular Glue Drug Development Summit 2024 回顾
Transcript: Hello, and welcome to Certara Talks. I’m Doctor Suzanne Minton, and I’m a director of content strategy at Certara . Today, I’m talking to my colleague, doctor Joshua Apgar. Joshua, welcome to Certara talks. Would you like to introduce yourself? Sure. Thank you. I’m, Josh Apgar, one of the co founders at applied Balmain, … Continued
AACR Annual Meeting 2024
对被忽视的热带病治疗的审批提供支持
In this video, Dr. Mark Sullivan, Managing Director of Medicines Development for Global Health, explains how Certara’s model-informed drug development expertise was used to support developing moxidectin as a treatment for onchocerciasis “river blindness.” Transcript The role that Certara has played has really been a as an as a integral part of our drug development … Continued
Certara 将于 2024 年 5 月 7 日发布 2024 年第一季度财报并参加 BofA Securities Healthcare Conference
PRINCETON, N.J.— 2024 年 4 月 9 日– Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today announced that it will release financial results for the first quarter of 2024 after the market close on Tuesday, May 7th, 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening … Continued
与代理公司合作取得更好成果的有效策略
For pharmaceutical companies, agencies play a crucial role in creating interactive content that effectively communicates product value to payers. However, in times of shrinking budgets, it becomes even more essential to ensure efficient collaborations with agencies to achieve optimal results. Traditional workflows often face challenges due to agency dependence, lengthy development cycles, and obstacles in … Continued
第五届监管-生物统计学术年会
深入解读 CDISC SDTM 合规性质量，探索优化之道【亚太地区网络讲座】
自 FDA 颁布法规要求递交的数据集需符合 CDISC 研究数据制表模型（SDTM）以来，临床试验申办方一直面临着一个难题。他们应该从一开始就按照 SDTM 设计电子病历报告表（eCRFs）吗？还是应该在最后阶段再将数据回溯性地转换为 CDISC SDTM？A retrospective … Continued
