Scientific Informatics

How to Manage Pre-clinical Data as a Strategic Asset

Stuart Horowitz

A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, […]

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Topics: Scientific Informatics

The Challenges of Determining Drug Dosing for Rare Diseases

Suzanne Minton

Most people are familiar with the leading causes of morbidity and mortality in the United States—heart disease, cancer, and diabetes. However, did you know that an estimated 350 million people worldwide suffer from rare diseases? In this blog post, I’ll be discussing what constitutes a rare disease, how developing orphan drugs to treat rare diseases […]

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Topics: PK/PD Modeling & Simulation

PBPK Modeling and Simulation Discussed at the AAPS Annual Meeting

Ellen Leinfuss

I recently got the chance to attend the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Diego, California. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. Pediatric drug development, in particular, remains a top challenge for the pharmaceutical industry as […]

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Topics: PBPK Modeling & Simulation

Why Phoenix NLME is the Best in Class Solution for Pop PK/PD

Ana Henry

Over the past 20 years, I have seen a number of significant changes in the pharmaceutical industry’s approach to the study of pharmacokinetics and pharmacodynamics (PK/PD). With the high risk and large expense associated with drug development, it is imperative to have the best PK/PD analytical tools to aid in understanding the safety/efficacy profile of […]

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Topics: PK/PD Modeling & Simulation