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Definition
| the general area of study concerned with the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms. |
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Definition
| the study of kinetics of absorption, distribution, metabolism and excretion (ADME) of drugs and their corresponding pharmacologic, therapeutic, or toxic responses in man and animals. |
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Definition
| the study of the factors influencing the bioavailability of a drug in man and animals and the use of this information to optimize pharmacological and therapeutic activity of drug products. |
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Definition
| is the relative amount of administered dose that reaches the general circulation and the rate at which it reaches the general circulation. |
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Definition
| a phenomenon where a substance may be capable of crystallizing in more than 1 crystalline form. |
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Definition
| the time (hr., min., etc) at which the administered drug reaches the therapeutic range or it (drug) begins to produce the effect. |
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Definition
| the time span (hr., min., etc), beginning the onset of action up to the termination of action. |
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Definition
| the time (hr., min.) at which the drug concentration in the plasma falls below the minimum effective concentration (MEC). |
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Definition
| process by which a drug proceeds from the site of administration to the site of measurement (usually blood, plasma or serum). |
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Definition
| the process of reversible transfer of drug to and from the site of measurement (usually blood or plasma). |
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Definition
| the process of conversion of one chemical species to another. |
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| the irreversible loss of drug from the site of measurement. Elimination of drugs occurs by two processes: metabolism and/or excretion. |
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| the irreversible loss of a drug in a chemically unchanged form. |
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Definition
| is defined as all the processes that occur subsequent to the absorption of the drug in extravascular route. Hence, by definition, the components of disposition phase are: distribution and elimination. |
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Definition
| describes the directly proportionality between the observed plasma concentration and the amount of drug eliminated and the dose administered. |
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Term
| Rapid drug distribution equilibrium |
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Definition
| simply suggests that the rates of transfer of drug molecules from blood to all organs and tissues and back to blood have become equal or almost equal (i.e. differences in rates are insignificant) instantaneously after administration of a drug. |
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Term
| Apparent volume of distribution (V or Vd) |
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Definition
| s simply a proportionality constant, whose sole purpose is to relate the plasma concentration (Cp) and the amount or mass of drug (X) in the body at a time. |
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Term
| Elimination Half-life (biological half-life |
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Definition
| is the time (hr., min., day, etc.) at which the mass (amount) of unchanged drug in the body (blood) becomes 1/2 or 50% of the initial mass of drug as soon as the equilibrium is established after administering a dose. |
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Term
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Definition
(mL/hr or mL/min)
is a proportionality constant that describes the relationship between a substance's rate of elimination (amount per unit time) at a time and its corresponding concentration in an appropriate body fluid or concentration at that time.
OR
is the hypothetical volume of blood (plasma or serum) or other biological fluids from which the drug is totally and irreversibly removed per unit time. |
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| Systemic (Cls) or Total Body Clearance (TBC) |
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Definition
| is the sum of all individual organ clearances that contribute to the overall elimination of drugs. |
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Definition
| the drug or the fraction thereof that is removed from the blood (plasma/serum) by the process of renal excretion. |
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| Metabolic clearance (Clm) |
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Definition
| the drug or fraction thereof that is removed from the blood (plasma/serum) by the process of metabolism from whatever metabolic organ. |
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Definition
| the drug or fraction thereof that is removed from the blood (plasma/serum) by the process of hepatic metabolism. |
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Definition
| the plasma or serum concentration (mcg/ml, ng/ml etc.) range, within which, the drug is likely to produce the therapeutic activity or effects. |
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Definition
| a dosage form that provides the maximum therapeutic effect with least amount of the drug and achieves the best results consistently. |
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Term
| Feathering, method of residual, or curve stripping |
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Definition
| a method that allows the separation of the monoexponential constituents of a biexponential plot of plasma concentration against time. |
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Term
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Definition
| the delay time in absorption following the administration of a drug by the oral or other extravascular route. |
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Term
| Time of maximum drug concentration, peak time (tmax) |
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Definition
| the time (hr, min, etc.) at which body displays maximum plasma concentration, (Cp)max, and it occurs when the rate of absorption is equal to the rate of elimination (i.e. KaXa = KX). |
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| Maximum Plasma Concentration (Cp) max (Peak Plasma Concentration) |
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Definition
| the plasma concentration (Cp) when time is equal to tmax. |
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Term
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Definition
is the relative amount of administered dose that reaches the general circulation and the rate at which it reaches the general circulation.
is the rate and extent to which the active ingredient or therapeutic moiety is absorbed from a product and becomes available at the site of drug action. |
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Term
| Pharmaceutically or Chemically Equivalent Products |
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Definition
| two or more drug products that contain equal amounts of the same therapeutically active ingredient (s) in identical dosage forms, and that these dosage forms meet the requirements such as purity, content uniformity and disintegration time as established by the U.S.P. and/or N.F. |
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Term
| Pharmaceutical Alternatives |
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Definition
| these are drug products that contain the same therapeutic moiety, but differ in salt or ester of that moiety or in the dosage form or strength. Also, controlled or modified release dosage forms are pharmaceutical alternatives when compared with conventional formulations of the same active ingredients. |
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Term
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Definition
| signifies that two or more chemically or pharmaceutically equivalent products essentially produce the same efficacy and/or toxicity in the same individuals when administered in identical dosage regimen. |
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Definition
| is assessed by comparing the values of (AUC)0∞ and/or cumulative mass of drug excreted in the urine (Xu)∞, obtained following the administration of a drug in a dosage form and an equivalent dose of the same drug intravenously (I.V. bolus). |
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Term
| Comparative (relative) bioavailability |
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Definition
| is assessed by comparing the bioavailability parameters ((AUC)0∞, (Cp)max and tmax) derived from plasma drug concentration- time plot data and/or urinary excretion data obtained following the administration of a drug in two different dosage forms (i.e. tablet and syrup, capsule and suspension, etc.) and/or by two different extravascular routes of administration (i.e. oral and intramuscular). |
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Term
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Definition
a type of comparative or relative bioavailability study. However, in a bioequivalence study, we compare (AUC)0∞, (Cp)max and tmax for two or more chemically or pharmaceutically equivalent products (identical dosage forms) and at least one of them is an innovator product (Brand Name or Trade Name), also known as a Reference Standard.
or
two or more chemically or pharmaceutically equivalent products produce comparable bioavailability characteristics in any individual when administered in equivalent dosage regimen. (Parameters compared include (AUC)0∞, (Cp)max and tmax).
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Term
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Definition
| Immediately following its absorption (through gut lumen and gut wall), a drug first passes via hepatic portal vein to the liver where metabolism of the drug, due to enzymes, may take place. This is called first pass effect. |
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Term
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Definition
| The ratio of the [rate of elimination] to the [rate at which drug enters an organ]. Extraction ratio is a dimensionless term that quantifies the efficiency of an organ with respect to drug elimination. |
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Definition
| when the rate of elimination and the rate of infusion become equal and it occurs, theoretically, only when time is equal to infinity |
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Term
| Steady State Concentration (ug/ml) |
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Definition
| the plasma concentration that corresponds to true steady state, attainable only at time infinity |
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| Practical Steady State Concentration (mcg/ml) |
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Definition
| when plasma concentration of the drug in the blood or body is within 5% of true steady state plasma concentration |
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Term
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Definition
| fraction comparing the molecular weight of a drug’s salt form to its corresponding free acid or free base form |
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Definition
| when, under a given dosing regimen, the mass of drug administered or absorbed is equal to the mass of drug eliminated over a dosing interval |
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Definition
| single dose administered to reach steady state concentration instantly |
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Term
| Maintenance Dose (mg; mg/kg) |
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Definition
| the dose administered every dosing interval to maintain the steady state concentration and condition |
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Term
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Definition
| the buildup of drug in the blood or body due to sequential dosing |
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Definition
| permits the determination of the amount of (and/or the plasma concentration) of a drug in the body at any time following the administration of the "nth" dose by extravascular and/or intravascular routes |
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Definition
| a measure of the magnitude of variation or differences between the peak and trough plasma concentrations at steady state (or between the peak and average plasma concentrations at steady state) |
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Term
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Definition
| The systematized dosage schedule for a drug therapy, or the optimized dose (X0) and dosing interval (tau) for a specific drug. |
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