Therapeutic dosing regimen

Once the steady-state concentration is known, the rate of dmg clearance determines how frequendy the dmg must be adininistered. Because most dmg elimination systems do not achieve saturation under therapeutic dosing regimens, clearance is independent of plasma concentration of the dmg. This first-order elimination of many dmgs means that a constant fraction of dmg is eliminated per unit time. In the simplest case, clearance can be deterrnined by the dose and the area under the curve (AUC) describing dmg concentration as a function of total time ... 

Once die steady-state concentration is known, the rate of drug clearance determines how frequently the drug must be administered. Because most drug elimination systems do not achieve saturation under therapeutic dosing regimens, clearance is independent of plasma concentration of the drug. 

Volume of distribution (VDss), a drug-disposition parameter relating the amount of drug in the body to the concentration of the drug in the blood (or tissue), tries to address the how often question in the therapeutic dose regimen. 

A direct prediction of immunogenicity potential in humans (the incidence and/or severity) based on animal studies using a therapeutic dosing regimen with a biopharmaceutical (not designed to invoke a strong immune response) is very challenging. However, there is the need for a more reliable way to... 

Usually, one has obtained an estimate for the elimination constant and the distribution volume Vp from a single intravenous injection. These pharmacokinetic parameters, together with the interval between administrations 0 and the single-dose D, then allow us to compute the steady-state peak and trough values. The criterion for an optimal dose regimen depends on the minimum therapeutic concentration (which must be exceeded by and on the maximum safe... 

The empiric use of a standard-dose (or double-dose) PPI as a therapeutic trial may be used in diagnosing GERD. This approach is less expensive, more convenient, and more readily available than ambulatory pH monitoring. Problems with this diagnostic approach include lack of a standardized dosing regimen and duration of the diagnostic trial. 

Upon the administration of 0.27 mg of a therapeutic agent to a normal individual, the elimination rate constant was found to be 0.0315 hour 1. The normal dosing regimen included 0.27 mg qid. If the elimination rate constant in renally impaired condition is 80% of the normal elimination rate constant, how can the dose be adjusted maintaining the same dosing interval of six hours ... 

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