Blog Archives

Blog

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…

CertaraFebruary 16, 2018

Blog

Using PBPK Models to Assess Fetal Drug Exposure

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting…

CertaraJanuary 19, 2018

Blog

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…

CertaraMay 25, 2017

Blog

Using Pharmacokinetics to Assure Chemical Food Safety

As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes,…

CertaraMay 12, 2017

Blog

How AI Tech Is Changing Regulatory Writing

Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For…

CertaraApril 21, 2017

Blog

The Model-informed Precision Dosing Revolution Is Coming

Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global…

CertaraMarch 7, 2017

Blog

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…

CertaraOctober 21, 2016

Blog

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…

CertaraSeptember 13, 2016

Blog

Arming Adherence-based Drug Development with Pharmacometrics

The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients,…

CertaraSeptember 12, 2016

Blog

The Role of a U.S. Agent

Foreign sponsors of drug applications who want to conduct business in the United States need…

CertaraSeptember 6, 2016

Blog

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Using PBPK Models to Assess Fetal Drug Exposure

Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis

Using Pharmacokinetics to Assure Chemical Food Safety

How AI Tech Is Changing Regulatory Writing

The Model-informed Precision Dosing Revolution Is Coming

Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug

FDA’s New Module 1 is a Bridge to eCTD 4

Arming Adherence-based Drug Development with Pharmacometrics

The Role of a U.S. Agent

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