Blog Archives

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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

Assessing Drug-Smoking Interactions Using PBPK Modeling

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn't…

CertaraJuly 29, 2016

Blog

How to Prepare a Study Data Standardization Plan (SDSP) for FDA

Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…

CertaraJuly 25, 2016

Blog

Status of QSP Modeling in the Pharmaceutical Industry

A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…

CertaraJuly 6, 2016

Blog

Diving into Best Practices for Pooling Clinical Trial Data

Learn the best practices for pooling clinical trial data. Discover how effective data integration enhances…

CertaraJune 3, 2016

Blog

Submitting eCTD in Advance of a Milestone Application

While advanced GPS systems and the advent of Big Data analytics are negating some of…

CertaraMay 10, 2016

Blog

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

Assessing Drug-Smoking Interactions Using PBPK Modeling

How to Prepare a Study Data Standardization Plan (SDSP) for FDA

Status of QSP Modeling in the Pharmaceutical Industry

Diving into Best Practices for Pooling Clinical Trial Data

Submitting eCTD in Advance of a Milestone Application

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