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Drug titration is the process of adjusting the dose of a medication for the maximum benefit without adverse effects. [1] When a drug has a narrow therapeutic index, titration is especially important, because the range between the dose at which a drug is effective and the dose at which side effects occur is small. [2]
Tacrolimus, sold under the brand name Prograf among others, is an immunosuppressive drug. After allogenic organ transplant , the risk of organ rejection is moderate. To lower the risk of organ rejection, tacrolimus is given.
For many drugs, severe toxicities in humans occur at sublethal doses, which limit their maximum dose. A higher safety-based therapeutic index is preferable instead of a lower one; an individual would have to take a much higher dose of a drug to reach the lethal threshold than the dose taken to induce the therapeutic effect of the drug.
The fixed-dose procedure (FDP), proposed in 1992 by the British Toxicology Society, is a method to assess a substance's acute oral toxicity. [ 1 ] [ 2 ] In comparison to the older LD 50 test developed in 1927, this procedure produces similar results while using fewer animals and causing less pain and suffering. [ 3 ]
mTOR inhibitors are a class of drugs used to treat several human diseases, including cancer, autoimmune diseases, and neurodegeneration. They function by inhibiting the mammalian target of rapamycin (mTOR) (also known as the mechanistic target of rapamycin), which is a serine/threonine-specific protein kinase that belongs to the family of phosphatidylinositol-3 kinase (PI3K) related kinases ...
As larger doses of these pharmaceuticals are administered the plasma concentrations of the unmetabolized drug increases and the elimination half-life increases. It is therefore necessary to adjust the dose or other treatment parameters when a high dosage is required.
Tacrolimus has been found to reduce episodes of organ rejection over a related treatment, the drug ciclosporin, which binds cyclophilin. [ 4 ] [ 5 ] Both the FKBP-tacrolimus complex and the cyclosporin-cyclophilin complex inhibit a phosphatase called calcineurin , thus blocking signal transduction in the T- lymphocyte transduction pathway. [ 6 ]
A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a pre-clinical , phase I or early phase II clinical trial.