GLOSSARYi

Question 0

Is the process of uptake of the compound from the site of administration into the systemic circulation.

Answer 0

Absorption

Question 1

Is the extent or fraction of drug absorbed upon extravascular administration in comparison to the dose size administered

Answer 1

Absolute Bioavailability

Question 2

Is the increase of drug concentration in blood and tissue upon multiple dosing until steady state is reached.

Answer 2

Accumulation

Question 3

Is the ratio of the concentrations at equilibrium between a lipid phase and an aqueous phase.

Answer 3

Apparent Partition Coefficient

Question 4

Is the integral of drug blood level over time from zero to infinity and is a measure of quantity of drug absorbed and in the body

Answer 4

Area Under the Curve

Question 5

Is mathematically defined by AUMC. It is the area under the curve observed for the product of time and concentration versus time.

Answer 5

Area Under First Statistical Moment Curve

Question 6

Is the phenomenon that drugs emptied via bile into the small intestine can be reabsorbed from the intestinal lumen into systemic circulation

Answer 6

Biliary Recycling

Question 7

Is defined both the relative amount of drug from an administered dosage form which enters the systemic circulation and the rate at which the drug appears in the blood stream.

Answer 7

Bioavailability

Question 8

Is achieved if its extent and rate of absorption are not statistically significantly different from those of the standard when administered at the same molar dose

Answer 8

Bioequivalence

Question 9

Is a requirement imposed by the Food and Drug Administration for in vitro and/or in vivo and testing of specified drug products which must be satisfied as a condition of marketing

Answer 9

Bioequivalence Requirement

Question 10

Deals with the physical and chemical properties of the drug substance, the dosage form, and the body and the biological effectiveness of a drug and/or drug product upon administration

Answer 10

Biopharmaceutics

Question 11

Is the actual site of action of drugs in the body

Answer 11

Biophase

Question 12

Is the speed of blood perfusion in an organ, usually expressed in ml/100 g organ weight/min

Answer 12

Blood Flow Rate

Question 13

Demonstrate the concentration in the blood, plasma or serum upon administration of dosage form by various routes of administration

Answer 13

Blood-, Plasma- or Serum-Levels

Question 14

Is the sum of all body regions (organs and tissue) in which the drug concentration is in instantaneous equilibrium with that in blood or plasma

Answer 14

Central Compartment

Question 15

Is the study of pharmacokinetic drug parameters as affected by circadian rhythm or diurnal variation

Answer 15

Chronopharmacokinetics

Question 16

Is the biological clock controlling rhythms of processes during a twenty-four hour cycle which is based on endogenous factors

Answer 16

Circadian Rhythm

Question 17

Is the application of pharmacokinetic principles in the safe and effective treatment of individual patients, and the optimization of drug therapy

Answer 17

Clinical Pharmacokinetics

Question 18

Is an entity in which can be described by a definite volume and a concentration of drug contained in that volume

Answer 18

Compartment

Question 19

Is the difference in the concentration in two phases usually separated by a membrane

Answer 19

Concentration Gradient

Question 20

Is the ratio of creatinine excreted in urine to the concentration of creatinine in plasma

Answer 20

Creatinine Clearance

Question 21

Are plots of the actual cumulative amounts of drug and/or its metabolites excreted into urine versus time upon administration of a drug product by various routes of administration

Answer 21

Cumulative Urinary Excretion Curves

Question 22

Is that portion of a prolonged release dosage form which liberates the drug from the dosage form at a slower rate than its unrestricted absorption rate

Answer 22

Depot Phase

Question 23

Is the viscous layer of concentrated drug solution around a dissolving particle

Answer 23

Diffusion Layer

Question 24

Is the loss of drug from the central compartment due to transfer (distribution) into other compartments and/or elimination and metabolism

Answer 24

Disposition

Question 25

Is the biological clock controlling rhythms of processes during a twenty-four hour cycle which is based on external synchronizers

Answer 25

Diurnal Variation

Question 26

Is the systematized dosage schedule for therapy

Answer 26

Dosage Regimen or Dose Rate

Question 27

Refers to a change of one or more of the pharmacokinetic processes of absorption, distribution, metabolism and excretion with increasing dose size

Answer 27

Dose Dependency

Question 28

Is a term used to describe the achievement of sustained drug concentration by simply increasing the dose size or by accidental drug release of drug from a sustained release dosage form

Answer 28

Dose Dumping

Question 29

Is the graphical presentation of the pharmacological or clinical effectiveness or toxicity (response) versus dose

Answer 29

Dose-Response Curve

Question 30

Is the amount of drug in mcg, mg units or other dimensions to be administered

Answer 30

Dose Size

Question 31

Is the time period between administration of maintenance doses

Answer 31

Dosing Interval

Question 32

Is a chemical compound of synthetic, semisynthetic, natural or biological origin which interacts with human or animal cells

Answer 32

Drug

Question 33

Is a drug product, usually of unvarying composition, labeled with a registered trademark of a single company

Answer 33

Drug Specialty or Brand Product

Question 34

Is the delivery of the active ingredient from a dosage form into solution

Answer 34

Drug Release or Liberation

Question 35

Is the gross pharmaceutical form containing the active ingredient(s) [drug(s)] and vehicle substances necessary in formulating a medicament of desired dosage, desired volume and desired application form, ready for administration

Answer 35

Drug Product or Dosage Form

Question 36

Is the time in hours necessary to reduce the drug concentration in the blood, plasma or serum to one-half after equilibrium is reached

Answer 36

Elimination Half-Life

Question 37

Is the phenomenon in which drugs emptied via bile into the small intestine can be reabsorbed from the intestinal lumen into systemic circulation

Answer 37

Enterohepatic Recirculation (Biliary Recycling)

Question 38

Is the increase in enzyme content or rate of enzymatic processes resulting in faster metabolism of a compound

Answer 38

Enzyme Induction

Question 39

Is the decrease in rate of metabolism of a compound usually by competition for an enzyme system

Answer 39

Enzyme Inhibition

Question 40

Is the final elimination from the body's systemic circulation via the kidney into urine via bila and saliva into intestines and into feces via sweat skin and milk

Answer 40

Excretion

Question 41

Refers to all routes of admn except those where the drug indirectly introduced into blood stream

Answer 41

Extravascular Administration

Question 42

Refers to a graphical method for the separation of exponents such as separating the absorption rate constant form the elimination rate constant

Answer 42

Feathering (residual method)

Question 43

Describes the phenomenon whereby drugs maybe metabolized following absorption but before reaching systemic circulation

Answer 43

First-pass effect

Question 44

Is the phenomenon observed if the rate of absorption is slower than the rate of elimination

Answer 44

Flip-flop model

Question 45

Is part of the alimentary canal comprising stomach small intestine and large

Answer 45

GIT

Question 46

Is a drug product marketed under the nonproprietary or common name the drug

Answer 46

Generic product

Question 47

Is the hypothetical volume of distribution in ml of the unmetabolized drug which is cleared one minute via the liver

Answer 47

Hepatic clearance

Question 48

Is the maintenance of a steady state wc characterizes the internal environment

Answer 48

Homeostasis

Question 49

Is that portion of a prolonged release dosage form which is immediately available for absorption

Answer 49

Initial phase

Question 50

Is the theoretical unrestricted maximum clearance of unbound drug by an eliminating organ.

Answer 50

Intrinsic clearance

Question 51

Is the period of time which elapses between the time of administration and the time a drug is found in the blood

Answer 51

Lag time

Question 52

The dose size initiating therapy so as to yield therapeutic concentration to wc will result clinical effectiveness

Answer 52

Loading priming initial dose