Non-Linear Flashcards
What is linear vs. nonlinear pharmacokinetics?
Linear - parameters do not change when different or multiple doses of a drug are given.
Nonlinear - increased doses or chronic administration can cause deviations from profile observed with single doses of the same drug.
Saturation Kinetics: Is elimination kinetics linear or nonlinear?
nonlinear
Saturation Kinetics: Does elimination half-life change as dose increases?
Yes
Saturation Kinetics: AUC is disproportional to amount of bioavailable drug. T/F
True
Saturation of capacity-limited processes may be affected by what?
Other drugs requiring the same enzyme of carrier-mediated system.
Saturation Kinetics: Composition and/or ration of the metabolites of a drug may be affected by what?
A change in the dose
What is Vmax?
maximum elimination rate (units of concentration over time)
What is Km?
Michaelis constant that reflects the capacity of the enzyme system. (units of concentration)
What is nonlinear pharmacokinetics?
It refers to kinetic processes that result in disproportional changes in plasma concentrations when the dose is changed.
What are usually not constant with nonlinear pharmacokinetics?
Clearance and half-life
What are bioavailability studies?
Drug product performance studies used to define the effect of changes in the physiochemical properties of the drug substance, the formulation of the drug, and manufacturing process of the drug product.
What are bioequivalence studies?
Drug product performance tests that compare the bioavailability of the same active pharmaceutical ingredient from one product to a second drug product.
What is bioequivalence?
Bioequivalence is established if the in vivo bioavailability of a test drug product does not differ significantly from that of the reference listed drug in the product’s rate and extent of drug absorption.
