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There are four different methods namely dose by factor, similar drug, pharmacokinetically guided, and comparative approaches are described in literature to assess the initial dose.[1] The dose by factor method is an empirical approach and use the no observed adverse effect levels (NOAEL) of drug from preclinical toxicological studies to estimate human equivalent dose (HED).[2] Here, the dose selection is based on minimum risk of toxicity, instead of choosing one with minimum pharmacologic activity in humans
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