How Drug Discovery Tools Aid Pharma Decision-Making
Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics
Author: Jim Gallagher
Why Medical Writing Services Use Style Guides & Lexicons
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
示范主文件在与 FDA 共享、接受和交流方面的作用
Certara 公布 2023 年第四季度财报
Provides Full Year 2024 Financial Guidance PRINCETON, N.J.— 2024 年 2 月 29 日– Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today reported its financial results for the fourth quarter of fiscal year 2023. Fourth Quarter Highlights: “We are encouraged by our strong fourth quarter results, driven by improved execution across both software and services,” said William … Continued
Simcyp 群体模拟器中 PBPK 建模复合文件开发指南
The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation. It links in vitro data to in vivo absorption, distribution, metabolism, excretion and pharmacokinetic/pharmacodynamic outcomes to explore clinical scenarios and …
生物识别技术情况说明书
RAPS: 生成式人工智能将如何使您的法规和医学撰写项目更上一层楼？
Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies. For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents. Tools that incorporate generative artificial intelligence (AI) can … Continued
如何在 FDA 的监管下开发孤儿药
罕见病是公共卫生领域的优先事项。FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
靶向放射治疗的剂量优化考量
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued
