eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus
Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…
Jim Gallagher2022 年 3 月 22 日
Certara Selected by the European Medicines Agency to Provide Real World Solutions for Critical Regulatory Decisions
Princeton, N.J., 2022 年 3 月 17 日 -- Certara, Inc. today announced a four-year, framework service contract…
Certara2022 年 3 月 17 日
How to Fix Your Biggest Bioequivalence Mistakes
生物等效性是生物药剂学中普遍被误解的术语。For starters, bioequivalence is a technical term…
Certara2022 年 3 月 16 日
Experts Unravel the Top 5 Myths Related to Bioequivalence
生物等效性通过药代动力学桥接口服药物剂型的安全性与有效性，The concepts…
Certara2022 年 2 月 18 日
The Challenging Road to Developing an Integrated Platform for Drug Discovery and Precision Medicine Using the Power of Pharmacometrics
We have often seen Dr. Hwi-yeol (Thomas) Yun, Associate Professor/Adjunct Professor at the College of…
Certara2022 年 2 月 7 日
Improved Workflow and Expanded functionality of RsNLME v1.1
R Speaks NLME (RsNLME) is a collection of R packages and companion RShiny apps that…
Jim Gallagher2022 年 1 月 31 日
Choosing an eCTD Submissions Vendor: Your Complete Checklist
Selecting the right electronic submission services vendor for your organization’s regulatory submissions to health authorities…
Certara2022 年 1 月 28 日
Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development
This blog will reflect on 3 things drug developers should pay attention to regarding safety…
Certara2022 年 1 月 24 日
