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Both pathways required that the bulk drug substance either appear on FDA's approved list or be a component of an FDA-approved drug

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NOAEL, the highest dose level that does not cause significant adverse effects, is a typical index for safety obtained from proper animal experiments to determine a safe starting dose.[7] In step 2, the NOAELs value is converted to HED on the basis of the body surface area correction factor (i.e., W 0.67 , which depends on the animal weight), using appropriate scaling factors from animal species.[11] Table 1 summarizes the factors for converting doses

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0.51 mL) into a fresh syringe and tap out air bubbles do not add any diluent