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Biopharmaceutics > Chapter 1: Definition of Terms > Flashcards

Chapter 1: Definition of Terms Flashcards

1
Q

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, i.e., the drug availability to the human or animal body from a given dosage form, considered as a drug delivery system. The time course of the drug in the body and the quantifying of the drug concentration pattern are explained by pharmacokinetics

A

Biopharmaceutics

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2
Q

deals with the changes of drug concentration in the drug product and changes of concentration of a drug and/or its metabolite(s) in the human or animal body following administration, i.e., the changes of drug concentration in the different body fluids and tissues in the dynamic system of liberation, absorption, distribution, body storage, binding, metabolism, and excretion

A

Pharmacokinetics

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3
Q

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

A

Clinical Pharmacokinetics

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4
Q

uses equations to characterize certain phenomena such as protein binding, adsorption, and nonlinear or saturation processes often observed with increasing dose sizes

A

Michaelis-Menten Kinetics

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5
Q

refers to a change of one or more of the pharmacokinetic parameters during absorption, distribution, metabolism and excretion by saturation or overloading of processes due to increased dose sizes

A

Nonlinear Kinetics or Saturation Kinetics

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6
Q

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

A

Chrono pharmacokinetics

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7
Q

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

A

Circadian Rhythm

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8
Q

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

A

Diurnal Variation

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9
Q

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

A

Area Under the Curve

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10
Q

mathematically defined by AUMC = ∫ 0∞ tCdt, i.e., it is the area under the curve observed for the product of time and concentration versus time

A

Area Under First Statistical Moment Curve

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11
Q

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

A

Blood-, Plasma- or Serum-Levels

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12
Q

plots of drug concentration versus time on numeric or semi-log graph paper. Blood-, plasma- or serum-levels are 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

A

Blood-, plasma- or serum-level curves

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13
Q

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

A

Cumulative Urinary Excretion Curves

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14
Q

the ratio of the concentrations at equilibrium between a lipid phase (usually n-octanol) and an aqueous phase (usually buffer pH 7.4). The apparent partition coefficient is uncorrected for dissociation or association in either phase

A

Apparent Partition Coefficient

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15
Q

are composite rate constants consisting of two or more micro constants. a and ẞ are hybrid rate constants

A

Hybrid Rate Constants

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16
Q

are those constants which are part of the hybrid constants. Micro constants are for instance k12, k21, k13

A

Micro Constants

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17
Q

refers to a graphical method for the separation of exponents such as separating the absorption rate constant from the elimination rate constant, or the a-slope from the ẞ-slope, or the absorption rate constant from the a-rate constant.

A

Feathering

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18
Q

the process with the slowest rate constant in a system of simultaneous kinetic processes

A

Rate Limiting Step

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19
Q

is not a “real” volume but an artifact – a hypothetical volume of body fluid that would be required to dissolve the total amount of drug at the same concentration as that found in the blood. It is a proportionally constant relating the amount of drug in the body to the measured concentration in biological fluid (blood, plasma or serum)

A

Volume of Distribution

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20
Q

the time in hours necessary to reduce the drug concentration in the blood, plasma or serum to one-half after equilibrium is reached. The elimination half-life may be influenced by: dose size, variation in urinary excretion (pH), intrasubject variation, age, protein binding, other drugs and diseases (especially renal and liver diseases). Loss of drug from the body, as described by the elimination half-life, means the elimination of the administered parent drug molecule (not its metabolites) by urinary excretion, metabolism or other pathways of elimination (lung, skin, etc.)

A

Elimination Half-Life of a drug

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21
Q

refers to all routes of administration except those where the drug is directly introduced into the blood stream. Extravascular routes are: I.M., S.C., P.O., Oral, Rectal, I.P., Topical, etc.

A

Extravascular Administration

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22
Q

refers to all routes of administration where the drug is directly introduced into the blood stream, i.e., I.V., Intraarterial, and Intracardiac; bioavailability 100 percent, f = 1

A

Intravascular Administration

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23
Q

includes buccal, sublingual and perlingual administration routes where the drug is absorbed from the mouth cavity (no first-pass effect)

A

Oral Administration

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24
Q

indicates that the dosage form is swallowed and the drug is absorbed from the GI-tract (first-pass effect possible)

A

Peroral Administration

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25
Q

occurs when the next dose of the same drug is administered only after the drug of the previous dose is completely eliminated from the body

A

Single Dose Administration

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26
Q

is when a drug is given repeatedly at intervals shorter than those required to completely eliminate the drug of the previously given dose

A

Multiple Dose Administration

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27
Q

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

A

Accumulation

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28
Q

is a level of drug accumulation in blood and tissue upon multiple dosing when input and output are at equilibrium. The steady state drug concentrations fluctuate (oscillate) between a maximum and a minimum steady state concentration within each dosing interval

A

Steady State

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29
Q

is the maintenance of a steady state which characterizes the internal environment of the healthy organism. An important function of homeostasis is the regulation of the fluid medium and volume of the cell

A

Homeostasis

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30
Q

is the period of time which elapses between the time of administration and the time a measurable drug concentration is found in blood, Lag times are often found upon P.O: administration due to slow disintegration and dissolution of 1 tablets or capsules

A

Lag Time

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31
Q

is the time when 63.2 percent of an intravenous dose has been eliminated from the pharmacokinetic system

A

Mean Transit or Residence Time

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32
Q

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

A

Concentration Gradient

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33
Q

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

A

Diffusion Layer

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34
Q

is defined as 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

A

Bioavailability

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35
Q

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

A

Absolute Bioavailability

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36
Q

is the extent of drug absorbed upon extravascular administration in comparison to the dose size of a standard administered by the same route

A

Relative Bioavailability

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37
Q

deals with the complex dynamic processes of liberation of an active ingredient from the dosage form, its absorption into systemic circulation, its distribution and metabolism in the body, the excretion of the drug from the body and the achievement of response

A

LADMER-System

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38
Q

is the delivery of the active ingredient from a dosage form into solution. The dissolution medium is either a biological fluid or an artificial test fluid (in vitro). Drug release is characterized by the speed. (liberation rate constant) and the amount of drug appearing in solution.

A

Drug Release or Liberation

39
Q

is the process of uptake of the compound from the site of administration into the systemic circulation. A prerequisite for absorption is that the drug be in aqueous solution. The only relatively rare exception is absorption by pinocytosis

A

Absorption of drugs

40
Q

the sum of all the chemical reactions for biotransformation of endogenous and exogenous substances which take place in the living cell

A

Metabolism

41
Q

the final elimination from the body’s systemic circulation via the kidney into urine, via bile and saliva into intestines and into feces, via sweat, via skin and via milk

A

Excretion of drugs

42
Q

the increase in enzyme content or rate of enzymatic processes resulting in faster metabolism of a compound. If a drug stimulates its own metabolism, it is called auto-induction, and, if it is caused by other compounds, it is called foreign-induction

A

Enzyme Induction

43
Q

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

A

Enzyme Inhibition

44
Q

describes the phenomenon whereby drugs may be metabolized (not chemically degraded) following absorption but before reaching systemic circulation. Hepatic first-pass effect may occur following P.O. and deep rectal administration. It may be avoided by using sublingual and buccal routes of administration. Pulmonary first-pass effect cannot be avoided by intravenous, buccal or sublingual routes

A

First-Pass Effect

45
Q

is a part of the alimentary canal comprising stomach, small intestine and large intestine

A

Gastrointestinal Tract

46
Q

is the phenomenon observed if the rate of absorption is slower than the rate of elimination, or if one of the distribution rates is slower than the rate of elimination

A

Flip-Flop Model

47
Q

is the actual site of action of drugs in the body. It is the drug-receptor interaction on molecular level or the influence of biopolymers by the presence of drug. The biophase may be the surface of a cell or within the cell, i.e., one of the organelles

A

Biophase

48
Q

is the combining of a drug molecule with the receptor for which it has affinity, and the initiation of a pharmacologic response by its intrinsic activity

A

Drug-Receptor Interaction

49
Q

is a site in the biophase to which drug molecules can be bound. A receptor ( = substrate) is usually a protein or proteinaceous material

A

Receptor

50
Q

is the phenomenon which occurs when a drug combines with plasma protein (particularly albumin) or tissue protein to form a reversible complex. Protein binding is usually non-specific and depends on the drug’s affinity to the protein molecule, the number of protein binding sites, protein and drug concentration. Drugs can be displaced from protein binding by other compounds having higher affinity for the binding sites

A

Protein Binding

51
Q

is the physical barrier to transport in the body. It is lipoidal in nature and consists of a double row of phospholipids sandwiched between one layer each of protein

A

Unit Membrane

52
Q

in pharmacokinetics is an entity which can be described by a definite volume and a concentration of drug contained in that volume. In pharmacokinetics, experimental data are explained by fitting them to compartment models

A

Compartment

53
Q

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. The blood or plasma is always part of the central compartment

A

Central Compartment

54
Q

is the sum of all body regions (i.e., organs, tissues or parts of it) to which a drug eventually distributes, but is not in instantaneous equilibrium. The peripheral compartment is sometimes further subdivided into a Shallow and a Deep Compartment

A

Peripheral Compartment

55
Q

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

A

Disposition

56
Q

is the 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 (renal, hepatic and other pathways of elimination)

A

Clearance

57
Q

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

A

Intrinsic Clearance

58
Q

is the ratio of creatinine excreted in urine to the concentration of creatinine in plasma. The creatinine clearance decreases with renal impairment and with age

A

Creatinine Clearance

59
Q

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

A

Hepatic Clearance

60
Q

is the hypothetical plasma volume in ml (volume of distribution) of the unmetabolized drug which is cleared in one minute via the kidney

A

Renal Clearance

61
Q

describes the clearance of the hypothetical plasma volume in ml (volume of distribution) of a drug per unit time due to excretion via kidney, liver, lung, skin, etc. and metabolism

A

Total Clearance

62
Q

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

A

Biliary Recycling (Enterohepatic Recirculation)

63
Q

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

A

Enterohepatic Recirculation (Biliary Recycling)

64
Q

is the phenomenon that occurs when drugs filtered through the glomeruli are reabsorbed from the tubuli into systemic circulation

A

Urinary Recycling

65
Q

is obtained when the drug product is administered at the site where the pharmacological response is desired and when the drug released from the product acts by adsorption to the skin or mucosa or penetrates into the skin or mucosa, but does not enter the systemic blood circulation or lymphatic stream

A

Local Effect

66
Q

is obtained when the drug released from the drug product enters the blood and/or lymphatic streams and is distributed within the body-or at least in several organs, regardless of the site and route of administration

A

Systemic Effect

67
Q

is a chemical compound of synthetic, semisynthetic, natural or biological origin which interacts with human or animal cells. The interactions may be quantified, whereby these resulting actions are intended to prevent, to cure or to reduce ill effects in the human or animal body, or to detect disease-causing manifestations

A

Drug

68
Q

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

A

Drug Product or Dosage Form

69
Q

is a drug product, usually of unvarying composition, labeled with a registered trade mark of a single company

A

Drug Specialty or Brand Product

70
Q

is a drug product marketed under the nonproprietary or common name of the drugs(s)

A

Generic Product

71
Q

are drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount, or dosage form or as the same salt or ester

A

Pharmaceutical Alternatives

72
Q

are drug products that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, in identical dosage forms, but not necessarily containing the same inactive ingredients

A

Pharmaceutical Equivalents

73
Q

of a drug product 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

A

Bioequivalence

74
Q

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

A

Bioequivalence Requirement

75
Q

are those whose pharmacological action is not directly dependent on chemical structure. They have no functional groups, are highly lipophilic and do not react, easily. They act by physico-chemical processes. Examples include: ether, nitrous oxide, halothane, phenol, ethyl alcohol, octyl alcohol, acetone

A

Structural Nonspecific Drugs

76
Q

are those whose pharmacological action results primarily from their chemical structure. They have functional groups, and combine to the three-dimensional structure of receptors in the biophase. Examples include anti- biotics, sulfonamides, glycosides, alkaloids, etc.

A

Structural Specific Drugs

77
Q

is the property of prolonged release dosage forms where the liberation (drug release) rate constant is smaller than the unrestricted absorption rate constant

A

Sustained Release

78
Q

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

A

Depot Phase

79
Q

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

A

Initial Phase

80
Q

are defined as substances that have no pharmacological properties of their own in the amount used, but which can improve the penetration of drugs into the skin or their permeation through skin or mucosa by reducing the barrier resistance

A

Sorption Promoters or Permeation Enhancers

81
Q

is the carrier of the drug in the drug product. It is composed of all necessary vehicle substances. Vehicle Substances are additives which are necessary in formulating a dosage form from the drug. The vehicle substances should be chemically inert and should not have any pharmacological effect in the dose used

A

Vehicle

82
Q

are used to produce, from a relatively small amount of drug, a dosage form of the desired strength, volume, form or consistency suitable for administration

A

Vehicle substances

83
Q

is the systematized dosage schedule for therapy, i.e., the proper dose sizes and proper dosing intervals required to produce clinical effectiveness or to maintain a therapeutic concentration in the body

A

Dosage Regimen or Dose Rate

84
Q

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

A

Dose Dependency

85
Q

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

A

Dose Dumping

86
Q

is the graphical presentation of the pharmacological or clinical effectiveness or toxicity (response) versus dose. A log dose-response curve is sigmoid with a straight-line middle section; a log dose-probability curve results in an entirely straight line

A

Dose-Response Curve

87
Q

is the amount of drug in μg (=mcg), mg, units or other dimensions to be administered

A

Dose Size

88
Q

is the time period between administration of maintenance doses

A

Dosing Interval

89
Q

is the dose size used in initiating therapy so as to yield therapeutic concentration which will result in clinical effectiveness

A

Loading Dose, Priming Dose or Initial Dose

90
Q

is the dose size required to maintain the clinical effectiveness or therapeutic concentration according to the dosage regimen

A

Maintenance Dose

91
Q

is a physiologic nonsense and poor use (misuse) of language. A bolus (Greek: bolos) is a bite, something solid which is swallowed and is then absorbed from the intestines. The correct term would be I.V. Push

A

I.V. Bolus

92
Q

is the speed of blood perfusion in an organ, usually expressed in ml/100g organ weight/min. Blood flow rates may differ several-fold between rest, or immobilization, and exercise

A

Blood Flow Rate

93
Q

is the determination and recording of drug concentrations during the course of therapy in order to adjust, if necessary, the dosage regimen

A

Monitoring

94
Q

is a patient’s body weight minus the fat mass. Drugs of low lipid solubility should be dosed in obese patients according to the lean body weight

A

Lean Body Weight

Biopharmaceutics (4 decks)

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