Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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The Role of Data in Propelling Clinical Trial Progress

Posted on April 1st, 2019 by in Pharma R&D

It’s a well known fact that the majority of drugs in development never make it to market despite the immense amount of time, money and effort. The application of data and analytics solutions to the R&D process as early as possible has proven to be a pivotal strategy to help improve trial design.

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Why a reliable FAERS searching capability is essential for pharma companies

Posted on October 27th, 2017 by in Pharmacovigilance

In the description of the FDA Adverse Event Reporting System (FAERS), the agency states that “voluntary and mandatory reporting plays an important role in the FDA’s post-market safety monitoring.” (more…)

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In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined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.” (more…)

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.”

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