Blog Archives

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

Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications

Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…

CertaraMarch 14, 2016

Blog

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation…

CertaraFebruary 23, 2016

Blog

How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients

Immuno-oncology, which harnesses the patient's own immune system to fight cancer, is one of the…

CertaraFebruary 16, 2016

Blog

Conventional & Mechanistic IVIVC: Complementary or Clashing Methods?

An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters…

CertaraFebruary 9, 2016

Blog

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…

CertaraDecember 1, 2015

Blog

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

Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients

Conventional & Mechanistic IVIVC: Complementary or Clashing Methods?

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

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