Therapeutic Index Determination

Therapeutic index determination quantitates safety margin between therapeutic and toxic doses. Ratio of TD50 to ED50 defines index breadth. Narrow index drugs require careful dosing. Wide index drugs tolerate dose variability. Population heterogeneity influences therapeutic index in individuals.

Regulatory submissions justify therapeutic index adequacy. Clinical monitoring detects toxicity indicating index inadequacy. Dose adjustment accounts for individual variation. Post-approval surveillance confirms index appropriateness. Therapeutic drug monitoring guides dose optimisation.