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Since 2019, National Centralized Volume-Based Procurement uses "passes generic-consistency evalulation" as one of the bidding criteria. [7] The Chinese definition of "bioequivalence" entails having the test drug's geometric mean C max, AUC (0–t), and AUC (0–∞) fall into 80%–125% of the reference drug in both fasting and fed states. The ...
The concept of selectivity is used to quantify the extent to which one chemical substance, A, binds each of two other chemical substances, B and C. The simplest case is where the complexes formed have 1:1 stoichiometry. Then, the two interactions may be characterized by equilibrium constants K AB and K AC.
However, if a delay is observed between the drug administration and the drug effect, a temporal dissociation needs to be taken into account and more complex models exist: [6] [7] Direct vs Indirect link PK/PD models; Direct vs Indirect response PK/PD models [8] Time variant vs time invariant; Cell lifespan models; Complex response models
A 1977 article compares the "classical" trapezoidal method to a number of methods that take into account the typical shape of the concentration plot, caused by first-order kinetics. [ 8 ] Notwithstanding the above knowledge, a 1994 Diabetes Care article by Mary M. Tai purports to have independently discovered the trapezoidal rule. [ 9 ]
To ensure that the drug taker who has poor absorption is dosed appropriately, the bottom value of the deviation range is employed to represent real bioavailability and to calculate the drug dose needed for the drug taker to achieve systemic concentrations similar to the intravenous formulation. [4]
Ligand efficiency is a measurement of the binding energy per atom of a ligand to its binding partner, such as a receptor or enzyme. [1]Ligand efficiency is used in drug discovery research programs to assist in narrowing focus to lead compounds with optimal combinations of physicochemical properties and pharmacological properties.
The Scatchard equation is an equation used in molecular biology to calculate the affinity and number of binding sites of a receptor for a ligand. [1] It is named after the American chemist George Scatchard.
In epidemiology and biostatistics, the experimental event rate (EER) is a measure of how often a particular statistical event (such as response to a drug, adverse event or death) occurs within the experimental group (non-control group) of an experiment. [1]