Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial

ASBASJSM COLLEGE OF PHARMACY

COLLEGE OF(AN AUTONOMOUS COLLEGE) BELA
PHARMACY
(An Autonomous College)
BELA (Ropar) Punjab

Name of Unit Pharmacokinetics

Course/Subject Name Biopharmaceutics and Pharmacokinetics
Course/Subject Code BP604T
Class: B. Pharm. Semester 6th
Faculty: Gurminder Kaur
Email id [email protected]
Mobile No. 6283849096

Learning Outcome of Unit-3

LO Learning Outcome(LO) Course

Outcome
LO1 Students will learn about the various aspects of compartment and BP604.4
non- compartment modeling.
LO2 BP604.4
Students will learn about the calculation and significance of different
pharmacokinetic parameters.

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CONTENT OF MODULE

Topic
Pharmacokinetics

Definition and introduction to Pharmacokinetics.

Compartment models.

Non compartment models , Physiological models.

One compartment open model, Intravenous Injection (Bolus)

Intravenous infusion, Extra vascular administrations

Pharmacokinetic Parameters

KE

t1/2

Vd

AUC

Ka,

Clt and CLR- definitions methods of eliminations understanding of their

significance and application

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PHARMACOKINETICS

Definition and introduction to Pharmacokinetics:

Dosage regimen: The frequency of administration of a drug in a particular dose is called as
dosage regimen.
Therapeutic window: The therapeutic and the toxic effects, depend upon the concentration of
drug at the site of action which is difficult to measure. However, it corresponds to a specific
concentration of drug in plasma which can be measured with accuracy. The drug fails to elicit a
therapeutic response when the concentration is below the effective level and precipitates adverse
reactions when above the toxic level. The plasma drug concentration between these two limits is
called as the therapeutic concentration range or therapeutic window (the ratio of maximum safe
concentration to minimum effective concentration of the drug is called as the therapeutic index).
Pharmacokinetics: Pharmacokinetics is defined as the kinetics of drug absorption, distribution,
metabolism and excretion (KADME) and their relationship with the pharmacological,
therapeutic or toxicological response in man and animals.
Plasma Drug Concentration-Time Profile: A direct relationship exists between the
concentration of drug at the biophase (site of action) and the concentration of drug in plasma.
Two categories of parameters can be evaluated from a plasma concentration time profile –
1. Pharmacokinetic parameters, and
2. Pharmacodynamic parameters.
A typical plasma drug concentration-time curve obtained after a single oral dose of a drug and
showing various pharmacokinetic and pharmacodynamic parameters is depicted in Fig. given
below. Such a profile can be obtained by measuring the concentration of drug in plasma samples
taken at various intervals of time after administration of a dosage form and plotting the
concentration of drug in plasma (Y-axis) versus the corresponding time at which the plasma
sample was collected (X-axis).
Pharmacokinetic Parameters
The three important pharmacokinetic parameters that describe the plasma level-time curve and
useful in assessing the bioavailability of a drug from its formulation are –

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Fig. A typical plasma concentration-time profile showing pharmacokinetic and

pharmacodynamic parameters, obtained after oral administration of single dose of a drug.

1. Peak Plasma Concentration (Cmax)

The point of maximum concentration of drug in plasma is called as the peak and the
concentration of drug at peak is known as peak plasma concentration. It is also called as peak
height concentration and maximum drug concentration. Cmax is expressed in mcg/ml. The
peak plasma level depends upon –
(a)The administered dose
(b)Rate of absorption, and
(c)Rate of elimination.
The peak represents the point of time when absorption rate equals elimination rate of drug. The
portion of curve to the left of peak represents absorption phase i.e. when the rate of absorption
is greater than the rate of elimination. The section of curve to the right of peak generally
represents elimination phase i.e. when the rate of elimination exceeds rate of absorption. Peak

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concentration is often related to the intensity of pharmacological response and should ideally be
above minimum effective concentration (MEC) but less than the maximum safe concentration
(MSC).
2. Time of Peak Concentration (tmax)
The time for drug to reach peak concentration in plasma (after extravascular administration) is
called as the time of peak concentration. It is expressed in hours and is useful in estimating the
rate of absorption. Onset time and onset of action are dependent upon tmax. This parameter is of
particular importance in assessing the efficacy of drugs used to treat acute conditions like pain
and insomnia which can be treated by a single dose.
3. Area Under the Curve (AUC)
It represents the total integrated area under the plasma level-time profile and expresses the total
amount of drug that comes into the systemic circulation after its administration. AUC is
expressed in mcg/ml X hours. It is the most important parameter in evaluating the bioavailability
of a drug from its dosage form as it represents the extent of absorption. AUC is also important
for drugs that are administered repetitively for the treatment of chronic conditions like asthma or
epilepsy.
Pharmacodynamic Parameters
The various pharmacodynamic parameters are –
Minimum Effective Concentration (MEC)
It is defined as the minimum concentration of drug in plasma required to produce the therapeutic
effect. It reflects the minimum concentration of drug at the receptor site to elicit the desired
pharmacological response. The concentration of drug below MEC is said to be in the sub-
therapeutic level.
In case of antibiotics, the term minimum inhibitory concentration (MIC) is used. It describes
the minimum concentration of antibiotic in plasma required to kill or inhibit the growth of
microorganisms.
Maximum Safe Concentration (MSC): Also called as minimum toxic concentration (MTC),
it is the concentration of drug in plasma above which adverse or unwanted effects are
precipitated. Concentration of drug above MSC is said to be in the toxic level.

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Onset of Action
The beginning of pharmacological response is called as onset of action. It occurs when the
plasma drug concentration just exceeds the required MEC.
Onset Time
It is the time required for the drug to start producing pharmacological response. It corresponds to
the time for the plasma concentration to reach MEC after administration of drug.
Duration of Action
The time period for which the plasma concentration of drug remains above the MEC level is
called as duration of drug action. It is also defined as the difference between onset time and
time for the drug to decline back to MEC.
Intensity of Action
It is the maximum pharmacological response produced by the peak plasma concentration of drug.
It is also called as peak response.
Therapeutic Range
The drug concentration between MEC and MSC represents the therapeutic range. It is also
known as therapeutic window.
Therapeutic Index
The ratio of MSC to MEC is called as therapeutic index. It is also defined as the ratio of dose
required to produce toxic or lethal effects to dose required to produce therapeutic effect.
COMPARTMENT MODELS:
Model: Model is a hypothesis using mathematical terms to describe quantitative relationships
concisely.
The key parameters in a process are commonly estimated by fitting the model to the
experimental data, known as variables. A pharmacokinetic parameter is a constant for the drug
that is estimated from the experimental data. For example, estimated pharmacokinetic parameters
such as k depend on the method of tissue sampling, the timing of the sample, drug analysis, and
the predictive model selected.
Such mathematical models can be devised to simulate the rate processes of drug absorption,
distribution, and elimination to describe and predict drug concentrations in the body as a
function of time. Pharmacokinetic models are used to:
2. Predict plasma, tissue, and urine drug levels with any dosage regimen.

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3. Calculate the optimum dosage regimen for each patient individually.
4. Estimate the possible accumulation of drugs and/or metabolites.
5. Correlate drug concentrations with pharmacologic or toxicologic activity.
6. Evaluate differences in the rate or extent of availability between formulations
(bioequivalence).
7. Describe how changes in physiology or disease affect the absorption, distribution, or
elimina- tion of the drug.
8. Explain drug interactions.

A very simple and useful tool in pharmacokinetics is compartmentally based models. For
example, assume a drug is given by intravenous injection and that the drug dissolves (distributes)
rapidly in the body fluids. One pharmacokinetic model that can describe this situation is a tank
containing a volume of fluid that is rapidly equilibrated with the drug. The concentration of the
drug in the tank after a given dose is governed by two parameters:
(1) The fluid volume of the tank that will dilute the drug, and
(2) The elimination rate of drug per unit of time.
Though this model is perhaps an overly simplistic view of drug disposition in the human body, a
drug’s pharmacokinetic properties can frequently be described using a fluid-filled tank model
called the one-compartment open model . In both the tank and the one-compartment body model,
a fraction of the drug would be continually eliminated as a function of time. In pharmacokinetics,
these parameters are assumed to be constant for a given drug. If drug concentrations in the tank
are determined at various time intervals following administration of a known dose, then the
volume of fluid in the tank or compartment (Vd, volume of distribution) and the rate of drug
elimination can be estimated.
Because a model is based on a hypothesis and simplifying assumptions, a certain degree of
caution is necessary when relying totally on the pharmacokinetic model to predict drug action.
For some drugs, plasma drug concentrations are not useful in predicting drug activity. For other
drugs, an individual’s genetic differences, disease state, and the compensatory response of the
body may modify the response to the drug. If a simple model does not fit all the experimental
observations accurately, a new, more elaborate model may be proposed and subsequently tested.

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Depending upon whether the compartments are arranged parallel or in a series, compartment
models are divided into two categories —
(a)Mammillary model (b)Catenary model.
Mammillary Model
This model is the most common compartment model used in pharmacokinetics. It consists of one
or more peripheral compartments connected to the central compartment in a manner similar to
connection of satellites to a planet (i.e. they are joined parallel to the central compartment). The
central compartment (or compartment 1) comprises of plasma and highly perfused tissues
such as lungs, liver, kidneys, etc. which rapidly equilibrate with the drug. The drug is directly
absorbed into this compartment (i.e. blood). Elimination too occurs from this compartment since
the chief organs involved in drug elimination are liver and kidneys, the highly perfused tissues
and therefore presumed to be rapidly accessible to drug in the systemic circulation. The
peripheral compartments or tissue compartments are those with low vascularity and poor
perfusion.
Catenary Model
In pharmacokinetics, the mammillary model must be distinguished from another type of
compartmental model called the catenary model. The catenary model consists of compartments
joined to one another like the compartments of a train. In contrast, the mammillary model
consists of one or more compartments around a central compartment like satellites. Because the
catenary model does not apply to the way most functional organs in the body are directly
connected to the plasma, it is not used as often as the mammillary model.
Physiologic Pharmacokinetic Model (Flow Model)
Physiologic pharmacokinetic models, also known as blood flow or perfusion models, are
pharmacokinetic models based on known anatomic and physiologic data. The models describe
the data kinetically, with the consideration that blood flow is responsible for distributing drug to
various parts of the body. Uptake of drug into organs is determined by the binding of drug in
these tissues. In contrast to an estimated tissue volume of distribution, the actual tissue volume is
used. Because there are many tissue organs in the body, each tissue volume must be obtained and
its drug concentration described. The model would potentially predict realistic tissue drug
concentrations, which the two-compartment model fails to do. Unfortunately, much of the
information required for adequately describing a physiologic pharmacokinetic model is

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experimentally difficult to obtain. In spite of this limitation, the physiologic pharmacokinetic
model does provide much better insight into how physiologic factors may change drug
distribution from one animal species to another.
NON COMPARTMENTAL ANALYSIS:
The non compartmental analysis, also called as the model-independent method, does not
require the assumption of specific compartment model. This method is, however, based on the
assumption that the drugs or metabolites follow linear kinetics, and on this basis, this technique
can be applied to any compartment model.
The non compartmental approach, based on the statistical moments theory, involves collection
of experimental data following a single dose of drug. If one considers the time course of drug
concentration in plasma as a statistical distribution curve, then:

Where MRT = mean residence time

AUMC = area under the first-moment curve AUC = area under the zero-moment curve

AUMC is obtained from a plot of product of plasma drug concentration and time (i.e. C.t) versus
time t from zero to infinity . Mathematically, it is expressed by equation:

AUC is obtained from a plot of plasma drug concentration versus time from zero to infinity.
Mathematically, it is expressed by equation:

Practically, the AUMC and AUC can be calculated from the respective graphs by the
trapezoidal rule (the method involves dividing the curve by a series of vertical lines into a

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number of trapezoids, calculating separately the area of each trapezoid and adding them together

Fig. AUC and AUMC plots

MRT (mean residence time) is defined as the average amount of time spent by the drug in the
body before being eliminated. In this sense, it is the statistical moment analogy of half-life, t½.
In effect, MRT represents the time for 63.2% of the intravenous bolus dose to be eliminated. The
values will always be greater when the drug is administered in a fashion other than i.v. bolus.
Applications of noncompartmental technique includes –
1. It is widely used to estimate the important pharmacokinetic parameters like
bioavailability, clearance and apparent volume of distribution.
2. The method is also useful in determining half-life, rate of absorption and first-order
absorption rate constant of the drug.
Advantages of noncompartmental method include —
1. Ease of derivation of pharmacokinetic parameters by simple algebraic equations.
2. The same mathematical treatment can be applied to almost any drug or metabolite
provided they follow first-order kinetics.
3. A detailed description of drug disposition characteristics is not required.

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Disadvantages of this method include –
1. It provides limited information regarding the plasma drug concentration-time profile.
More often, it deals with averages.
2. The method does not adequately treat non-linear cases.

ONE-COMPARTMENT OPEN MODEL:

The one-compartment open model is the simplest model. Owing to its simplicity, it is based on
following assumptions –
1. The body is considered as a single, kinetically homogeneous unit that has no barriers to
the movement of drug.
2. Final distribution equilibrium between the drug in plasma and other body fluids (i.e.
mixing) is attained instantaneously and maintained at all times. This model thus applies
only to those drugs that distribute rapidly throughout the body.
3. Drugs move dynamically, in (absorption) and out (elimination) of this compartment.
4. Elimination is a first-order (monoexponential) process with first-order rate constant.
5. Rate of input (absorption) > rate of output (elimination).
6. The anatomical reference compartment is plasma and concentration of drug in plasma
is representative of drug concentration in all body tissues i.e. any change in plasma drug
concentration reflects a proportional change in drug concentration throughout the body.
However, the model does not assume that the drug concentration in plasma is equal to that in
other body tissues. The term open indicates that the input (availability) and output (elimination)
are unidirectional and that the drug can be eliminated from the body.
Depending upon the rate of input, several one-compartment open models can be defined:
 One-compartment open model, i.v. bolus administration.
 One-compartment open model, continuous i.v. infusion.
 One-compartment open model, e.v. administration, zero-order absorption.
 One-compartment open model, e.v. administration, first-order absorption.

One-compartment open model, i.v. bolus administration:

While the oral route of drug administration is the most convenient, intravenous (IV)
administration is the most desirable for critical care when reaching desirable drug concentrations

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quickly is needed. Examples of when IV administration is desirable include antibiotic
administration during septic infections or administration of antiarrhythmic drugs during a
myocardial infarction. Because pharmacokinetics is the science of the kinetics of drug
absorption, distribution, and elimination, IV administration is desirable in understanding these
processes since it simplifies drug absorption, essentially making it complete and instantaneous.
When a drug that distributes rapidly in the body is given in the form of a rapid intravenous
injection (i.e. i.v. bolus or slug), it takes about one to three minutes for complete circulation and
therefore the rate of absorption is neglected in calculations. The model can be depicted as
follows:

The general expression for rate of drug presentation to the body is:

Since rate in or absorption is absent, the equation becomes:

If the rate out or elimination follows first-order kinetics, then:

where, KE = first-order elimination rate constant, and

X = amount of drug in the body at any time t remaining to be eliminated. Negative sign indicates
that the drug is being lost from the body.

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Fig. (a) Cartesian plot of a drug that follows one-compartment kinetics and given by rapid i.v.
injection, and (b) Semilogarithmic plot for the rate of elimination in a one-compartment model.
Co, KE (and t½) can be readily obtained from log C versus t graph. The elimination or removal
of the drug from the body is the sum of urinary excretion, metabolism, biliary excretion,
pulmonary excretion, and other mechanisms involved therein. Thus, KE is an additive property
of rate constants for each of these processes and better called as overall elimination rate
constant.

One-Compartment Open Model Intravenous Infusion:

Rapid i.v. injection is unsuitable when the drug has potential to precipitate toxicity or when
maintenance of a stable concentration or amount of drug in the body is desired. In such a
situation, the drug (for example, several antibiotics, theophylline, procainamide, etc.) is
administered at a constant rate (zero-order) by i.v. infusion. In contrast to the short duration of
infusion of an i.v. bolus (few seconds), the duration of constant rate infusion is usually much
longer than the half-life of the drug.
Advantages of zero-order infusion of drugs include
1. Ease of control of rate of infusion to fit individual patient needs.
2. Prevents fluctuating maxima and minima (peak and valley) plasma level, desired
especially when the drug has a narrow therapeutic index.

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3. Other drugs, electrolytes and nutrients can be conveniently administered simultaneously
by the same infusion line in critically ill patients.
The model can be represented as follows:

At any time during infusion, the rate of change in the amount of drug in the body, dX/dt is the
difference between the zero-order rate of drug infusion Ro and first-order rate of elimination,
–KEX:

Integration and rearrangement of above equation yields:

Since X = Vd C, the above equation can be transformed into concentration terms as follows:

Fig. Plasma concentration-time profile for a drug given by constant rate i.v. infusion (the two
curves indicate different infusion rates Ro and 2Ro for the same drug)

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At the start of constant rate infusion, the amount of drug in the body is zero and hence, there is
no elimination. As time passes, the amount of drug in the body rises gradually (elimination rate
less than the rate of infusion) until a point after which the rate of elimination equals the rate of
infusion i.e. the concentration of drug in plasma approaches a constant value called as steady-
state, plateau or infusion equilibrium.
At steady-state, the rate of change of amount of drug in the body is zero, hence, the equation
becomes:

Transforming to concentration terms and rearranging the equation:

Where, Xss and Css are amount of drug in the body and concentration of drug in plasma at
steady-state respectively. The value of KE (and hence t½) can be obtained from the slope of
straight line obtained after a semilogarithmic plot (log C versus t) of the plasma concentration-
time data gathered from the time when infusion is stopped. Alternatively,KE can be calculated
from the data collected during infusion to steady-state as follows:
Substituting Ro/ClT = Css we get

Fig. Semilog plot to compute KE from

infusion data upto steady-state

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One-Compartment Open Model Extravascular Administration(First Order):

Fig. The absorption and elimination phases of the plasma concentration-time profile obtained
after extravascular administration of a single dose of a drug.

The differential form of the equation is:

where, Ka = first-order absorption rate constant, and

Xa = amount of drug at the absorption site remaining to be absorbed i.e. ARA. Integration
of equation yields:

where F = fraction of drug absorbed systemically after e.v. administration.

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Assessment of Pharmacokinetic Parameters
C max and t max: At peak plasma concentration, the rate of absorption equals rate of
elimination i.e. KaXa =KEX and the rate of change in plasma drug concentration dC/dt = zero.
This rate can be obtained by differentiating equation

URINARY EXCRETION DATA

(Disposition Viewed from Urine only)
In the absence of plasma level-time data, useful information can still be obtained from urine data
regarding elimination kinetics of a drug. The method has several advantages in the analysis of a
pharmacokinetic system:
1. The method is useful when there is lack of sufficiently sensitive analytical techniques to
measure concentration of drugs in plasma with accuracy.
2. The method is non-invasive and therefore better subject compliance is assured.
3. The method is more convenient since it involves collection of urine samples in
comparison to drawing of blood periodically.
4. A less sensitive analytical method is required for determining urine drug concentration as
compared to plasma concentrations. If urine drug concentrations are low, assaying of
larger sample volumes is relatively easy.
5. First-order elimination, excretion and absorption rate constants and fraction excreted
unchanged can be computed from such data. First-order metabolism or extra-renal
excretion rate constant can also be calculated subsequently from the difference (KE – Ke)
= Km.

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6. Direct measurement of bioavailability, both absolute and relative, is possible without the
necessity of fitting the data to a mathematical model.
Criteria for Obtaining Valid Urinary Excretion Data
1. A significant amount of drug must be excreted unchanged in the urine (at least 10%).
2. The analytical method must be specific for the unchanged drug; metabolites should not
interfere.
3. Water-loading should be done by taking 400 ml of water after fasting overnight, to
promote diuresis and enable collection of sufficient urine samples.
4. Before administration of drug, the bladder must be emptied completely after 1 hour from
water-loading and the urine sample taken as blank.
5. The drug should then be administered with 200 ml of water and should be followed by
200 ml given at hourly intervals for the next 4 hours.
6. Volunteers must be instructed to completely empty their bladder while collecting urine
samples.
7. Frequent sampling should be done in order to obtain a good curve.
8. During sampling, the exact time and volume of urine excreted should be noted.
9. An individual collection period should not exceed one biological half-life of the drug and
ideally should be considerably less.
10. Urine samples must be collected for at least 7 biological half-lives in order to ensure
collection of more than 99% of excreted drug.
11. Changes in urine pH and urine volume may alter the urinary excretion rate.

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IMPORTANT QUESTIONS
Very short answer question 2 Marks:
1. Define pharmacokinetics.
2. In compartment modelling why does excretion takes place from central compartment
3. What are the limitations of one compartment model
4. Define elimination rate constant?
5. Describe the influence of Ke on Cmax , Tmax and AUC.
6. Mention the methods for calculating of AUC.
7. Define biological half life.
8. Enumerate the applications of pharmacokinetics.
9. What is first order and second order reaction?
10. What is Zero order reaction?
11. Write equation for zero and first order half life.
12. What do mean by therapeutic index?
13. Give an example for Mono exponential equation.
14. Give an example for Bi exponential equation.
15. Draw the blood level profiles for oral and intravenous route of administration.
16. Enlist different pharmacokinetic parameters.
17. Define Cmax and Tmax.
18. Classify Pharmacokinetic models.
19. What is multi compartment model?
20. Give the schematic representation of one compartment open model-oral.
21. Give the schematic representation of one compartment open model-IV.
22. Give the schematic representation of two compartment open model-oral.
23. Give the schematic representation of two compartment open model-IV.
24. Give the schematic representation of three compartments model-oral.
25. Give the schematic representation of three compartments model-IV.
26. What are the assumptions of one compartment model?
27. Give the formula AUC0-t & AUC0-∞.

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Short answer question 5 Marks:
1. Write a note on Catenary and mammillary modeling.
2. Write the importance of Compartment modeling in pharmacokinetic study.
3. With a neat labeled diagram explain the drug levels in blood after oral administration.
4. Explain various pharmacokinetic parameters after oral administration of drug.
5. Write the applications of pharmacokinetic models.
6. Explain how steady state level of the drug is achieved through I.V infusion.
7. Give schematic representation of two and three compartment models with brief explanation.
8. Explain the assumptions of one-compartment open model
9. Write about the advantages and disadvantages of compartment modeling.
10. Compare blood level curves between I.V and oral routes with a graph.
11. Give the mono exponential and bi exponential equations for drugs administered as IV bolus
and explain the terms.
12. How do you determine KE using rate of excretion method from urine data.
13. How do you determine KE using sigma minus method from urine data.
Long answer questions 10 Marks:
1. What do you understand by pharmacokinetic model? Classify the pharmacokinetic models,
give their salient features, advantages and disadvantages.
2. Discuss in detail one-compartment open model for a drug administered as IV Bolus. Give the
schematic representation, graphs and equations for the same.
3. Discuss in detail one-compartment open model for a drug administered as IV infusion. Give
the schematic representation, graphs and equations for the same
4. Discuss in detail two-compartment open model for a drug administered as IV Bolus. Give the
schematic representation, graphs and equations for the same.
5. What is a compartment? Classify the compartment models. Give the schematic representation
of the same.

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