Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Reducing Adverse Event Risk

Posted on September 25th, 2017 by in Pharma R&D

In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development, as part of an adequate assessment of the drug’s safety and effectiveness.” Continue reading “Reducing Adverse Event Risk” »

Big Data and Proactive Pharmacovigilance

Posted on September 20th, 2017 by in Pharmacovigilance

Traditionally thought of as a post-market process, pharmacovigilance is how pharmaceutical companies monitor and address any safety issues that arise once a drug becomes available commercially. However, some companies are now thinking ahead about these potential safety concerns with what is known as “proactive PV”. Continue reading “Big Data and Proactive Pharmacovigilance” »

Assessing DDI Risk in the Digital Age

Posted on August 9th, 2017 by in Pharmacovigilance

pills pic for SD case study
In their 2012 Drug Regulations, the U.S. Food and Drug Administration recommended that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development.”

Continue reading “Assessing DDI Risk in the Digital Age” »