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A low efficacy-based therapeutic index and a high safety-based therapeutic index are preferable for a drug to have a favorable efficacy vs safety profile. At the early discovery/development stage, the clinical TI of a drug candidate is unknown.
inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
For a response of 0.25a.u., Drug B is more potent, as it generates this response at a lower concentration. For a response of 0.75a.u., Drug A is more potent. a.u. refers to "arbitrary units". In pharmacology , potency or biological potency [ 1 ] is a measure of a drug's biological activity expressed in terms of the dose required to produce a ...
The ED50 is commonly used as a measure of the reasonable expectancy of a drug effect, but does not necessarily represent the dose that a clinician might use. This depends on the need for the effect, and also the toxicity. The toxicity and even the lethality of a drug can be quantified by the TD 50 and LD 50 respectively. Ideally, the effective ...
Many drugs have more than one name and, therefore, the same drug may be listed more than once. Brand names and generic names are differentiated by capitalizing brand names. See also the list of the top 100 bestselling branded drugs , ranked by sales.
The effects of drugs displacing each other and changing the clinical effect (though important in some examples) is vastly overestimated usually and a common example incorrectly used to display the importance of this effect is the anticoagulant warfarin. Warfarin is highly protein-bound (>95%) and has a low therapeutic index. Since a low ...
A high protective index is preferable to a low one: this corresponds to a situation in which one would have to take a much higher dose of a drug to reach the toxic threshold than the dose taken to elicit the therapeutic effect. A drug should ordinarily only be administered if the protective index is greater than one, indicating that the benefit ...
Because of the wide therapeutic index of the SSRIs, most patients will have mild or no symptoms following moderate overdoses. The most commonly reported severe effect following SSRI overdose is serotonin syndrome; serotonin toxicity is usually associated with very high overdoses or multiple drug ingestion. [179]