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The therapeutic index (TI) is the range of doses at which a medication is effective without unacceptable adverse events. Drugs with a narrow TI (NTIDs) have a narrow window between their effective doses and those at which they produce adverse toxic effects.
- Narrow Therapeutic Index drugs: clinical pharmacology perspective
Abstract. Objectives: Historically, the identification of...
- Narrow Therapeutic Index drugs: clinical pharmacology perspective
Narrow therapeutic index (NTI) drugs are defined as those drugs where small differences in dose or blood concentration may lead to dose and blood concentration dependent, serious therapeutic failures or adverse drug reactions.
The therapeutic index (TI; also referred to as therapeutic ratio) is a quantitative measurement of the relative safety of a drug with regard to risk of overdose. It is a comparison of the amount of a therapeutic agent that causes toxicity to the amount that causes the therapeutic effect. [1] .
4 Αυγ 2021 · At present, the FDA does not designate specific drugs as Narrow Therapeutic Index's. However, in the Code of Federal Regulation (21 CFR 320.33c), the FDA has provided a definition for drugs with a narrow therapeutic ratio based on median lethal and effective doses. This definition is as follows:
1 Νοε 2022 · 3 Learning Objectives. Recognize general characteristics of NTI drugs. Describe FDA’s approach and criteria to evaluate the bioequivalence of generic NTI drugs. Discuss examples of FDA’s...
31 Αυγ 2012 · The FDA defines narrow therapeutic index (NTI) drug products, in the scope of bioequivalence studies for generics, as “containing certain drug substances subject to therapeutic drug ...
7 Σεπ 2021 · Abstract. Objectives: Historically, the identification of drugs with the Narrow Therapeutic Index (NTI) has been empirically based on the clinical practice. In general terms, NTI drugs can be defined based on the steepness of the dose-response relationship and the degree of overlap between the effective and the toxic concentrations.
