0Uncertainty Factors Publisher



Yahyaeian AE¹ ; Shahidi M² ; Mousavi T¹ ; Daniali M¹
Source: Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 Published:2023

Abstract

Adverse drug reactions are responsible for a large number of hospitalization and death worldwide. In order to address this issue, the safety profile of each agent must be determined before approval and after marketing. This is implemented through preclinical toxicological studies and in different phases of clinical trials. In these stages, the use of uncertainty factors paves the way to better extrapolate results of animal studies, along with recognizing intra-individual variability, safe concentrations ratio, and so on, which are discussed comprehensively in this chapter. The application of uncertainty factors has resulted in depending on science-based factors, specifically chemical and toxicological issues, to describe default and standard methods. This science has been drastically improved in recent decades and will be replaced by computational sciences shortly. © 2024 Elsevier Inc. All rights reserved.