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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 ...
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 U.S. Food and Drug Administration also has guidance to elucidate dose–response relationships [3] during drug development. Dose response relationships may be used in individuals or in populations. The adage The dose makes the poison reflects how a small amount of a toxin has no significant effect, while a large amount may be fatal. This ...
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.
Boissel formulated the hypothesis that the antiarrhythmic drugs efficacy was a function combining a beneficial effect that is proportional to and a constant adverse effect (), independent of . The mathematical expression of this model is a linear equation with two parameters, the risk of lethal adverse event caused by treatment and the slope of ...
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 ...
The term "pharmacometrics" first appeared in literature in the preface of the 1964 book "Evaluation of Drug Activities: Pharmacometrics" [3]: The sub-title of the book is, as far as we are aware, a neologism, coined by one of us (A.L.B.), and the word is defined by the main title of the book, which could have been even more explicitly, if more verbosely, expressed as "The Identification and ...
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.