Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions
Analogous to how a geologist surveys the “lay of the land” to determine if oil…
Certara2018年2月16日
Using PBPK Models to Assess Fetal Drug Exposure
The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting…
Certara2018年1月19日
Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis
Do you get anxious about taking tests? Many people do because they want to show…
Certara2017年5月25日
Using Pharmacokinetics to Assure Chemical Food Safety
As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes,…
Certara2017年5月12日
How AI Tech Is Changing Regulatory Writing
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For…
Certara2017年4月21日
The Model-informed Precision Dosing Revolution Is Coming
Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global…
Certara2017年3月7日
Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug
Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a…
Certara2016年10月21日
FDA’s New Module 1 is a Bridge to eCTD 4
Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group…
Certara2016年9月13日
Arming Adherence-based Drug Development with Pharmacometrics
The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients,…
Certara2016年9月12日
The Role of a U.S. Agent
Foreign sponsors of drug applications who want to conduct business in the United States need…
Certara2016年9月6日
