CDER researchers are working on approaches to predict drug effects on human systems before clinical trials start. My earlier post on Physiological Based Pharmacokinetic Modeling discusses one such approach used for predicting human systemic exposure following dose administration of the candidate drug. Last fall the agency posted a story about the use of microengineered organ systems as a model to predict clinical toxicity. These tools offer a means for researchers to test the effects of drug exposure on a microphysiological system, organ-on-chip, organoid, or physiological cellular microsystem (depending on the technology used to create the system). The article discusses recent work on microengineered systems that model the human liver and heart, as these systems account for most of the unexpected side effects of candidate drugs. The article describes the four systems under study and includes a bibliography for further reading.

Text Copyright © 2019 Katrina Rogers