Basic Concepts - Terminology Flashcards
Process of uptake of the compound from the site of administration into systemic circulation
Absorption
Extent or fraction of drug absorbed upon extravascular administration in comparison to the dose size administered
Absolute bioavailability
A prerequisite for absorption
Drug must be in aqueous solution
Rate of constant of the entire process of drug transfer into the body, through all biological membrane
Absorption rate constant
Increase of drug concentration in blood and tissue upon multiple dosing until steady state is reached
Accumulation
Ratio of the concentration at equilibrium between a lipid phase (usually octanol) and an aqueous phase (buffer 7.4)
Apparent partition coefficient
Uncorrected for dissociation or association in either phase
Apparent partition coefficient
Integral of drug blood level over time from zero to infinity
Area under the curve
Measure of quantity of drug absorbed and in the body
Area under the curve
Phenomenon that the drug is emptied via bile to the small intestine can be reabsorbed from the intestinal lumen into systemic circulation
Biliary recycling or Enterohepatic Recirculation
Rate and extent to which an active drug substance or moiety is absorbed from the pharmaceutical dosage form and becomes available at its site of action
Bioavailability
Extent and rate of absorption are not statistically different from those of the standard when administered at the same molar dose
Bioequivalence
Requirement imposed by the FDA for in vitro and or invivo testing of specified drug product which must be satisfied as a condition of marketing
Bioequivalence Requirement
Deals with physical and chemical properties of the drug substance, the dosage form and the body and the biological effectiveness of a drug or drug products upon administration
(ex drug availability to the human or animal body from a given dosage form)
Biopharmaceutics
Considered as a drug delivery system
Biopharmaceutics
Actual site of action of a drug in the body
Biophase
Drug-receptor interaction on the molecular level or the effect of the presence of a drug on biopolymers
Biophase
Maybe the surface of a cell or within the cell
Biophase
Speed of blood perfusion in an organ, usually expressed in mL/100 g organ wt/min
Blood flow rate
May differ several-fold between rest and exercise
Blood flow rate
Concentration in blood, plasma, or serum upon administration of a dosage form by various routes of administration
Blood, plasma, or serum levels
Plots of drug concentration versus time on numeric or semilog graph paper
Blood, plasma, or serum level curves
Obtained from blood samples by venipuncture in certain time intervals after administration of the drug product and chemical or microbiological analysis of the drug in the biological fluid
Blood, plasma, or serum levels
Sum of all body regions (organs and tissue) in which the drug concentration is in instantaneous equilibrium with that in blood or plasma
Central compartment
Always a part of the central compartment
Blood and plasma
Hypothetical volume of distribution in mL of the unmetabolized drug which is cleared per unit of time (mL/min or mL/h) by any pathway of drug removal
Clearance
Entity which can be described by a definite volume and a concentration of drug contained in that volume
Compartment
Difference in the concentration in two phases usually separated by a membrane
Concentration gradient
Plots of the actual cumulative amouts of drug and/or its metabolites excreted into irine versus time upon administration of a drug product by various routes of administration
Cumulative urinary excretion curves
Portion of a prolonged release dosage form which liberates the drug from the dosage form at a slower rate than its unrestricted absorption rate
Depot phase
Viscous layer of concentrated drug solution around a dissolving particle
Diffusion layer
Loss of drug from the central compartment due to distribution into other compartments and or elimination
Disposition
Systematized dosage schedule for therapy
Dosage regimen or dose rate
Ex. The proper dose sizes and proper dosing intervals required to produce clinical effectiveness or to maintain a therapeutic concentration in the body
Dosage regimen or dose rate
A change of one or more of the pharmacokinetic process of absorption, distribution, metabolism and excretion with increasing dose size
Dose dependency
Describe the achievement of sustained drug concentration by simply increasing the dose size or by accidental fast release drug from sustained release dosage form
Dose dumping
Amount of drug in microgram, mg units
Dose size
Time period bet administration of maintenance dose
Dosing interval