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In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
The AUC (from zero to infinity) represents the total drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Another use is in the therapeutic drug monitoring of drugs with a narrow therapeutic ...
If we compare the two different dosage forms having same active ingredients and compare the two drug bioavailability is called comparative bioavailability. [18] Although knowing the true extent of systemic absorption (referred to as absolute bioavailability) is clearly useful, in practice it is not determined as frequently as one may think.
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 ...
Half maximal effective concentration (EC 50) is a measure of the concentration of a drug, antibody or toxicant which induces a biological response halfway between the baseline and maximum after a specified exposure time. [1] More simply, EC 50 can be defined as the concentration required to obtain a 50% [...] effect [2] and may be also written ...
Short term drug side effects are most likely to occur at or near the C max, whereas the therapeutic effect of drug with sustained duration of action usually occurs at concentrations slightly above the C min. [citation needed] The C max is often measured in an effort to show bioequivalence (BE) between a generic and innovator drug product. [4]
Intrinsic activity (IA) and efficacy (E max) refer to the relative ability of a drug-receptor complex to produce a maximum functional response. This must be distinguished from the affinity, which is a measure of the ability of the drug to bind to its molecular target, and the EC 50, which is a measure of the potency of the drug and which is proportional to both efficacy and affinity.
The ATE measures the difference in mean (average) outcomes between units assigned to the treatment and units assigned to the control. In a randomized trial (i.e., an experimental study), the average treatment effect can be estimated from a sample using a comparison in mean outcomes for treated and untreated units.