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In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined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

FDA Speeds Up Generic Approval Process

Posted on August 30th, 2017 by in Pharmacovigilance

Healthcare has been in the spotlight for much of the year so far, as Congress has wrestled with the difficult question of how to make it both better and more affordable.

Continue reading “FDA Speeds Up Generic Approval Process” »

Assessing DDI Risk in the Digital Age

Posted on August 9th, 2017 by in Pharmacovigilance

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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” »

The Eternal Triangle of Quality, Speed, and Cost

Posted on August 7th, 2017 by in Pharma R&D

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A designer colleague once described to me the key issue involved in many of their creative design projects. It is finding the best balance between quality, speed, and cost. From a buyer perspective, we desire high quality, rapid delivery, and low cost. Continue reading “The Eternal Triangle of Quality, Speed, and Cost” »

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