Human equivalent dose (HED) is a widely used concept in drug development, but it has limitations in accurately predicting the appropriate dose for humans based on animal studies alone. In this article, we will explore the limitations of HED and some of the alternatives that researchers are using to better predict drug dosing in humans. Limitations of HED One of the main limitations of HED is the assumption that metabolic rate scales predictably with body weight across species. However, metabolic rate can vary between species and can be affected by factors such as age, gender, and disease state. This variability can make it difficult to accurately predict the appropriate dosage for humans based on animal studies alone. Another limitation of HED is the lack of consideration for other factors that can affect drug metabolism and response in humans, such as genetic differences and drug-drug interactions. HED calculations assume that all humans have the same metabolic rate and response to
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