Stories about: mouse studies

When preclinical studies get dosing wrong, new drugs get lost in translation

Robin Kleiman, PhD, is Director of Preclinical Research at Boston Children’s Hospital’s Translational Neuroscience Center.

drug dosing preclinical studies

Basic research investigators are increasingly conducting translational research studies to advance their therapeutic approaches to clinical trials. Unfortunately, when testing drugs in rodent models of human disease, these studies often do not measure drug levels from their animal subjects to determine drug dosing.

This is understandable, since collecting these data can be very expensive and requires specialized expertise. But as a consequence, a lot of preclinical literature is published without any consideration of what drug concentration was actually achieved in the organ of interest. This is undercutting our efforts to get new therapies to patients.

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A calmer rodent is a better rodent for pain medication research

The global market for pain medications is huge — some estimates predict it will hit $41.6 billion by 2017. However, the costs of pain medicine development are huge, too; it takes roughly $900 million to bring a new analgesic compound to market. In part, this is because some 80 percent of compounds that look promising in preclinical animal studies (largely in rodents) fail in late-stage clinical trials.

David Roberson, MBA, a neuroscience graduate student in the F.M. Kirby Neurobiology Center at Boston Children’s Hospital, wants to make those preclinical studies better at predicting whether a new compound will work safely in people — by studying rodents at “home.”

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