> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Developing Ways to Predict Drug Effects Before Trials
- URL: https://www.fdaweb.com/fda-developing-ways-to-predict-drug-effects-before-trials/
- Published: 2019-04-10T12:00:00.000Z
- Updated: 2026-09-15T01:19:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143833

CDER researchers are developing microengineered human cellular systems that allow for replication of human physiology and better prediction of drug effects before clinical trials are started. An agency *Regulatory Science Impact Story* says limitations in detecting drug toxicity before clinical trials means that drug developers often conduct costly trials of new drug compounds only to have them fail when toxic effects are observed.

“Through a variety of projects,” the report [says](http://app.info.fda.gov/e/er?utm%5Fcampaign=New%20CDER%20Impact%20Story%3A%20Evaluating%20the%20Potential%20of%20Microengineered%20Human%20Cellular%20Systems&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6873&elqTrackId=11026DE32D6D3C09EABB9E70BEBFC6D0&elq=546e5348a818491f9d0c702e70d8ca13&elqaid=7530&elqat=1), “the Integrated Cellular Systems Laboratory in CDER’s Division of Applied Regulatory Science is studying how to use physiological cellular microsystems to advance drug development. Because hepatic and cardiac toxicities account for most of the unanticipated side effects of candidate drugs, CDER researchers are focusing on systems to advance our ability to model drugs’ effects on the liver and heart.”

The report says the platforms will be especially useful in contexts where clinical trials are limited or not feasible, such as efforts to develop medical countermeasures to public health emergencies and to evaluate therapies to treat rare diseases.