In 2011, FDA proposed tighter quality and bioequivalence (BE) standards for NTI drugs.Why is it important to determine the therapeutic index of drugs with known toxic effects? AnswerOn therapeutic prespective, there is tremendous opportunity in terms of harnessing protein therapeutics to alleviate disease. Narrow therapeutic index (NTI) drugs are those drugs where small differences in dose or blood concentration may cause serious adverse events or therapeutic failure. The related terms therapeutic window or safety window refer to a range of doses which optimize between efficacy and toxicity. It is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity. The therapeutic index is a quantitative measurement of the relative safety of a drug.
Therapeutic index is determined by the 'lethal dose' and the 'therapeutic dose' of a certain drug or pharmaceutical.The therapeutic dose is the amount of a drug, that when taken, physiological benefits are seen. Relates safety to a number). Although there is an established criterion of bioequivalence that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical.The therapeutic index essentially quantifies the safety of a drug (i.e. Therapeutic index and small increments of dose adjustment aretherapeutic index Pharmacology The ratio of a drug's toxic level to its therapeutic level, which is calculated as the toxic concentrationTC of a drug, divided by the effective concentration, expressed as TC 50 /EC 50, a point at which 50 of Pts have a toxic reaction to the drug being monitored the lower the therapeutic index, the more difficult it is to titrate a drug's dose in a Pt and. Therapeutic index 3 is a reasonable cutoff to define NTI drugs.
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They have a very narrow range of effectiveness when compared to the risk of adverse effects.
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