Tehran University of Medical Sciences

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Safety Testing, Clinical Studies Publisher



Nikfar S1 ; Mozaffari S2
Authors

Source: Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 Published:2023


Abstract

In order to evaluate a new studied product, its efficacy and safety in comparison to available alternatives (including no intervention), clinical trials are useful. Clinical safety studies are conducted in human volunteers to determine the safety of chemicals, drugs, formulations, devices, or other products that may come in contact with the human body. Clinical safety testing should always be conducted after animal safety studies and before investigating the efficacy of the test compound in patients and proceeding with further steps of clinical studies for drug approval. When designing a study, the benefit-risk ratio should be balanced and favorable. © 2024 Elsevier Inc. All rights reserved.
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