No Observable Effect Levels
Based on pre-clinical trials, No Observable Effect Levels (NOEL) on drugs are established, which are used to determine initial phase 1 clinical trial dosage levels on a mass API per mass patient basis. Generally a 1/100 uncertainty factor or "safety margin" is included to account for interspecies (1/10) and inter-individual (1/10) differences.
Read more about this topic: Pre-clinical Development
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