借助行业领导者的真知灼见，掌握临床阶段的转换！欢迎加入 QSP 高级副总裁兼负责人 Piet van der Graaf、QSP 神经科学建模负责人 Hugo Geerts、Certara 药物开发解决方案副总裁 Mirjam Trame 和 Certara 药物开发服务高级副总裁、药学博士 Julie M. Bullock 的行列。We are thrilled to welcome keynote speaker and panelist … Continued
Secondary pharmacology profiling involves the screening of small molecule compounds against a broad range of targets in order to try to predict off-target interactions leading to safety issues in humans. To date, this has generally required an opinion-based approach, but opinions vary and are inherently unreliable. To evaluate this quantitatively requires the use of surrogate … Continued
As regulatory acceptance of models for decision-making grows, so too does the need for optimally fit models, free as possible from human bias. This places high demands on the modeling workbench, which must build and fine-tuning thousands of models across a vast search space, then select a winner according to standard goodness-of-fit and custom criteria. … Continued
Advanced Strategies and Best Practices for Predictive Pharmacokinetics using Simcyp™ Discovery Refine your approach to early drug development with insights from industry experts in our upcoming webinar, “First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic Modeling (PBPK).” If you’re seeking strategies to identify and advance your small molecule drug candidates, expedite product profiling, formulation, … Continued
临床药理信息占药品说明书的 50% 以上。不完善的临床药理开发计划会导致申办方在审评期间遇到重大问题，或影响其上市申请的批准。Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of … Continued
临床药理信息占药品说明书的 50% 以上。不完善的临床药理开发计划会导致申办方在审评期间遇到重大问题，或影响其上市申请的批准。Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of … Continued
While the popularity of tools like ChatGPT have brought AI to the forefront of tech investments, nearly 73% of life science companies still struggle to adopt an appropriate AI technology. Some of the biggest challenges to successful adoption are clearly defined use cases, appropriately trained AI that understands scientific concepts and approachable applications for leveraging … Continued
Traditionally, PK Scientists have operated with locally installed applications to resume their PK analysis. In this environment the computer system was under control of the local IT department who would provide all necessary documentation expected by regulatory authorities to provide evidence that their computer system is CFR part 11 compliant. In the new world of … Continued
The PK scientist’s data pipeline handles a range of raw data types, including SAS, R, and other formats from multiple partners. This is particularly critical in complex trials with substantial data volumes. Effective data compliance management is vital, involving tailored compliance for exploratory studies and full compliance for clinical studies adhering to FDA’s Title 21 … Continued
As the drug development industry strives to accelerate submission timelines and improve patient access to healthcare solutions, regulatory professionals are increasingly pressured to leverage technology to go faster. During this webinar, Heather Graham, vice president of regulatory science and medical affairs at Certara, will facilitate a panel comprising industry experts to discuss the current technology … Continued
