APPLICATION OF PHARMACOKINETICS
M.PHARM (SEM-II).
DEPT. OF PHARMACEUTICS.
CONTENTS
Modified release drug products.
Targeted drug delivery systems.
Biotechnological products.
Introduction of PK & PD.
Drug interaction.
PK & PD of biotechnology drugs.
Proteins and peptides.
Monoclonal antibodies.
Oligonuclotides
Vaccines and gene therapies.
References 2
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GENERAL APPLICATION
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MODIFIED RELEASE DRUG PRODUCT
➢ Most conventional (immediate release) oral drug products, such
as tablets and capsules, are formulated to release the active drug
immediately after oral administration.
➢ In the formulation of conventional drug products, no deliberate
effort is made to modify the drug release rate.
➢ Immediate-release products generally result in relatively rapid
drug absorption and onset of accompanying pharmacodynamic
effects.
➢ In the case of conventional oral products containing prodrugs, the
pharmacodynamic activity may be slow due to conversion to the
active drug by hepatic or intestinal metabolism or by chemical
hydrolysis.
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➢ Alternatively, conventional oral products containing poorly
soluble (lipophilic drugs), drug absorption may be gradual due
to slow dissolution in or selective absorption across the GI tract,
also resulting in a delayed onset time.
➢ The pattern of drug release from modified-release (MR) dosage
forms is deliberately changed from that of a conventional
(immediate-release) dosage formulation to achieve a desired
therapeutic objective or better patient compliance.
➢ Types of MR drug products include delayed release (eg, enteric
coated), extended release (ER), and orally disintegrating tablets
(ODT).
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The term modified-release drug product is used to describe
products that alter the timing and/or the rate of release of
the drug substance.
Several types of modified-release oral drug products are
recognized:
Extended-release drug products. A dosage form that allows at
least a twofold reduction in dosage frequency as compared to
that drug presented as an immediate-release (conventional)
dosage form.
Examples of extended-release dosage forms include controlled-
release, sustained-release, and long-acting drug products.
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➢ Delayed-release drug products. A dosage form that releases a
discrete portion or portions of drug at a time other than
promptly after administration. (eg, enteric-coated aspirin and
other NSAID products).
➢ Targeted-release drug products. A dosage form that releases
drug at or near the intended physiologic site of action.
➢ Targeted-release dosage forms may have either immediate- or
extended-release characteristics.
➢ Orally disintegrating tablets (ODT). ODT have been
developed to disintegrate rapidly in the saliva after oral
administration. ODT may be used without the addition of
water.
➢ The drug is dispersed in saliva and swallowed with little or no
water. 7
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TARGETED DRUG DELIVERY SYSTEMS
Acceleration of delivery of drugs to organs and tissues.
Enhanced delivery by cationization
➢ Alteration of net charge by chemical modification is also an
effective approach for targeted delivery of protein drugs
➢ Cationic macromolecules are rapidly taken up by the liver,
primarily hepatocytes, via electrostatic interaction with
negatively charged cell surfaces.
➢ Although slower than that observed in receptor-mediated
endocytosis.
➢ Massive internalization of the proteins into the cell interior
occurs by absorptive endocytosis.
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Receptor-mediated delivery of therapeutic proteins
➢ Glycoconjugates have been extensively studied for active
targeting of protein drugs to specific cell types.
➢ Liver parenchymal cells, i.e., hepatocytes, express exclusively
asialoglycoprotein receptors, which recognize galactose terminal
residues of glycoproteins.
➢ Although the targeting efficiency depends on the molecular size
of a protein drug and the number of galactose moieties
conjugated, galactosylated proteins are almost completely
delivered to hepatocytes.
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Receptor-mediated delivery of particulate carriers
➢ Receptor-mediated endocytic pathways have been exploited for
cell-specific delivery of particulate carriers.
➢ Due to their sufficient size, particulate carriers have the potential
of being modified with a variety of functional molecules ranging
from small organic molecules to proteins.
➢ Bio distribution-based on the nature of carriers and method of
targeting.
➢ Metabolism- by hepatic enzymes.
➢ Clearence- based on the reservoir of drugs such as protein
binding, carriers, prodrugs etc.,
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INTRODUCTION TO PK & PD
➢ Introduction Pharmacology is the study of drugs.
➢ Pharmacodynamics is the effect that drugs have on the body.
➢ Pharmacokinetics is the effect the body has on the drugs.
➢ Pharmacokinetics includes
➢ Absorption
➢ Distribution
➢ Metabolism
➢ Excretion Of Drugs.
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Absorption
➢ The main factor which relates to absorption of drugs is the
route of administration.
➢ Physiological considerations in absorption are blood flow, total
surface area, time of arrival of the drug and time of drug at
absorption site.
➢ Other considerations for absorption are solubility, chemical
stability and how soluble the drug is in lipids.
Distribution
➢ Drugs are distributed into major body fluids (e.g. Plasma).
➢ Specific tissues may take up certain drugs (e.g. Iodine is taken
up by the thyroid gland).
➢ Drug distribution is affected by the extent that the drug binds
to plasma proteins.
➢ Drug distribution is affected by barriers (e.g. the placenta and
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Biotransformation
➢ This is a process of metabolizing drugs in the body.
➢ It occurs mainly in the liver and is therefore often called hepatic
metabolism.
➢ Some drugs are given that are activated by this hepatic
metabolism, these are called pro-drugs.
➢ Drug metabolism is split into two phases in the liver.
➢ An example of phase I metabolism would be oxidation,
➢ An example of phase II metabolism would be conjugation.
Excretion
➢ Excretion includes renal elimination and faecal elimination.
➢ The main method of renal elimination is by active glomerular
filtration.
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➢ Drugs can also be eliminated by passive methods in the distal
tubules.
➢ Drugs can be eliminated from the body in bile and so removed in
the faeces.
General and molecular aspects
➢ Drugs exert their effects at molecular (chemical) targets (e.g.
adrenaline receptors).
➢ Drugs can also act by stopping or partially stopping important
ions entering the cell (e.g. calcium channel blockers).
➢ Drugs can interfere with enzymes that are produced by the body.
➢ Drugs can work on the transport of chemicals into and out of
cells.
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Drug action
➢ Drug action relies on route of administration, rate of
absorption and manner of distribution.
➢ The duration of drug effect involves how quickly it is
removed from the body.
➢ Some drugs when absorbed from the stomach enter the
portal circulation and pass through the liver, this is called
the first pass effect.
➢ Drug action can also be affected by drug affinity.
➢ The greater the affinity the better the drug action.
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Agonistic and antagonistic drug action
➢ Agonists activate receptors to produce a response. Antagonists
bind with receptors but do not activate them or cause a
response.
➢ They can actually block the activation of receptors. Partial
agonists produce a response.
➢ However, this is less than would be expected by a full agonistic
drug.
➢ Inverse agonists are drugs which can reduce the normal activity
of the cell.
➢ Competitive antagonists are drugs that prevent activation of the
cell by their normal agent.
➢ Non-competitive antagonists are drugs that may block the
receptor but not in a permanent way. 16
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PHARMACOKINETIC DRUG INTERACTIONS:
1. ALTERATIONS IN ABSORPTION
a. Complexation/Chelation
b. Altered GI transit
c. Altered Gastric PH
d. Alteration in gastrointestinal microflora
2. ALTERATIONS IN PLASMA PROTEIN BINDING
3. ALTERATIONS IN HEPATIC METABOLISM
a. Induction of metabolism
b. Inhibition of metabolism
4. ALTERATIONS IN RENAL CLEARANCE(EXCRETION)
a. Increased renal blood flow
b. Inhibition of active tubular secretion
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c. Alterations in tubular re absorption
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ALTERATIONS IN ABSORPTION :
A. Complexation/ Chelation :
➢ Antacids (Mg2+, Al3+ ions) make complex with Tetracycline,
Ciprofloxacin reduced absorption of Tetracycline.
B. Altered GI Transit:
➢ Anticholinergics Block M3 receptors reduce motility delays the
absorption of Acetaminophen
C. Altered gastric pH:
➢ H2 blockers (Ranitidine, Cimetidine) reduce acid secretion
increase. pH reduce dissolution of Ketoconazole reduce
absorption of ketoconazole.
D. Altered Gastrointestinal microflora:
➢ Antibiotics kills the microflora of GIT Reduce the absorption of
oral contraceptives unwanted pregnancy.
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ALTERATIONS IN PLASMA PROTEIN BINDING :
Alterations in Plasma protein binding Sulfonamides,
Phenytoin (Highly protein bound) Displaces the Warfarin from
plasma protein binding elevates free Warfarin level increase
anticoagulant effect increase the risk of Bleeding
ALTERATIONS IN HEPATIC METABOLISM :
A.Induction of hepatic metabolism:
Phenobarbital (CYP Enzyme inducer) Increase the
metabolism of Warfarin Reduce the plasma level of warfarin
decreased anticoagulant effect.
B. Inhibition of Hepatic metabolism:
Metronidazole (CYP enzyme inhibitor) inhibits
metabolism of warfarin elevation of plasma Warfarin levels
raise the anticoagulant effect increased risk of Bleeding
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ALTERATIONS IN RENAL CLEARANCE:
A. Increase in Renal blood flow:
➢ Hydralazine (Vasodilator) dilates the renal blood vessels
increase the renal blood flow raise the clearance of Digoxin.
B. Inhibition of Active tubular secretion:
➢ Probenecid inhibits tubular secretion of Penicillins, increased
half life of Penicillins Single dose therapy.
C. Alterations in tubular reabsorption:
➢ Antacids reduce acid secretion, increase the pH of urine
reduced tubular reabsorption of Salicylates (Aspirin)
Increased renal clearance of Aspirin.
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PK & PD OF BIOTECHNOLOGY DRUGS
➢ Biotechnology is based on scientific knowledge from different
disciplines such as Microbiology, Biochemistry, Genetics,
Chemistry, Engineering and Computer Science for biological
agents such as microorganisms, cells or molecules (enzymes,
antibodies, DNA, etc.) to provide goods and ensure services
➢ BIOTECHNOLOGY PROCESSES Current biotechnological
processes essentially involve five different groups of organisms:
bacteria (e.g. Escherichia coli, Pseudomonas spp. Serratia
mascescens, Erwenia herbicola, Lactococcus lactis and Bacillus
subtilis),
➢ Fungi (e.g. Saccharomyces cerevisiae, Pichia and Hansenula,
Trichoderma and Aspergilli),
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➢ Plants (e.g. tobacco plant, rape and transgenic potatoes
(Tourte, 1998)),
➢ Insects (e.g. Spodoptra frugiperda) and mammalians
(e.g. Chinese hamster ovary cells (CHO), baby hamster
kidney cells (BHK) and transgenic animals)
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➢ In the future, biopharmaceuticals may be used against the
AIDS virus, different types of cancer, asthma, Parkinson’s
and Alzheimer’s disease.
➢ There are different groups of biopharmaceuticals, including:
antibiotics, blood factors, hormones, growth factors,
cytokines, enzymes, vaccines and monoclonal antibodies.
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PROTEIN
➢ Proteins are classified into two major groups based on their
shape.
➢ Fibrous proteins are long, rod-shaped molecules that are
insoluble in water and physically tough. Fibrous proteins,
such as the keratins found in skin, hair, and nails, have
structural and protective functions.
➢ Globular proteins are compact spherical molecules that
are usually water- soluble and have dynamic functions.
Nearly all enzymes have globular structures. Examples
immunoglobulins and the transport proteins hemoglobin
and albumin (a carrier of fatty acids in blood).
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➢ On the basis of composition, proteins are classified as simple
or conjugated.
➢ Simple proteins, such as serum albumin and keratin, contain
only amino acids.
➢ conjugated protein, consists of a simple protein combined
with a nonprotein component.
➢ The nonprotein component is called a prosthetic group.
➢ A protein without its prosthetic group is called an apoprotein.
➢ A protein molecule combined with its prosthetic group is
referred to as a holoprotein.
➢ Prosthetic groups typically play an important, even crucial,
role in the function of proteins.
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Conjugated proteins are classified according to the nature
of their prosthetic groups.
For example,
➢ Glycoproteins contains a carbohydrate component.
➢ Lipoproteins contains lipid molecules.
➢ Metalloproteins contain metal ions.
➢ Phosphoproteins contain phosphate groups.
➢ Hemoproteins possess heme groups
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PROTEIN STRUCTURE
➢ Primary structure
➢ Secondary structure
➢ Tertiary structure
➢ Quaternary structure
LOSS OF PROTEIN STRUCTURE
➢ The process of structure disruption, which may or may not
involve protein unfolding, is called denaturation.
(Denaturation is not usually considered to include the
breaking of peptide bonds.)
➢ Strong acids or bases, organic solvents, detergents, reducing
agents, salt concentration, heavy metal ions, temperature
changes, mechanical stress. 27
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PHARMACOKINETICS OF PROTEIN & PEPTIDE
➢ Pharmacokinetic and exposure–response concepts impact every
stage of the drug development process, starting from lead
optimization to the design of Phase III pivotal trials.
➢ An understanding of the concentration–effect relationship is
crucial to any drug – including peptides and proteins – as it
lays the foundation for dosing regimen design and rational
clinical application.
➢ Route of administration:Except oral
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DISTRIBUTION
➢ The volume of distribution of a peptide or protein drug is
determined largely by its physico-chemical properties (e. g.,
charge, lipophilicity), protein binding, and dependency on
active transport processes.
➢ Due to their large size – and therefore limited mobility through
biomembranes – most therapeutic proteins have small volumes
of distribution, typically limited to the volumes of the
extracellular space.
➢ After IV application, peptides and proteins usually follow a
biexponential plasma concentration–time profile that can best
be described by a two-compartment pharmacokinetic model.
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➢ The central compartment in this model represents primarily
the vascular space and the interstitial space of well-perfused
organs with permeable capillary walls, especially liver and
kidneys.
➢ while the peripheral compartment comprises the interstitial
space of poorly perfused tissues such as skin and (inactive)
muscle
Elimination
➢ In general, peptides and protein drugs are almost exclusively
eliminated by metabolism via the same catabolic pathways as
endogenous or dietary proteins, resulting in amino acids that
are reutilized in the endogenous amino acid pool for de-novo
biosynthesis of structural or functional body proteins.
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MONOCLONAL ANTIBODIES
Pharmacokinetic Characteristics of mAbs
➢ Compared to small-molecule drugs, therapeutic mAbs
display different pharmacokinetic characteristics, including
nonlinear pharmacokinetic behavior.
➢ As the majority of therapeutic mAbs present IgG (or more
specially IgG1) molecules, the emphasis will be placed on
this isotype, although the characteristics of newer types of
molecule such as antibody fragments will also be included.
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ABSORBTION
➢ Route-i.v, i.m, s.c
➢ The mechanism of absorption after SC or IM administration is
thought to occur via the lymphatic system.
➢ From the lymphatic vessels, the mAbs are transported uni-
directionally into the venous system.
Distribution
➢ In general, the distribution of classical mAbs in the body is
poor. Limiting factors are, in particular, the high molecular
mass and the hydrophilicity/polarity of the molecules.
➢ Nevertheless, mAbs are able to reach targets outside the
systemic circulation.
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Transport
➢ Permeation of mAbs across the cells or tissues is
accomplished by transcellular or paracellular transport,
involving the processes of diffusion, convection, and cellular
uptake.
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ELIMINATION
➢ Clearance
➢ As glomerular filtration has an approximate molecular size
limit of 20–30 kDa, mAbs do not undergo filtration in the
kidneys due to their relatively large size.
➢ The situation is different, however, for low molecular-mass
antibody fragments, which can be filtered.
➢ Tubular secretion has not been reported to occur to any
significant extent for mAbs, and peptides/small proteins are
readily reabsorbed in the proximal or distal tubule of the
nephron (potentially also mediated by the neonatal Fc
receptor, Fc-Rn), or are even metabolized.
➢ Thus, renal elimination in total is uncommon or low for
mAbs. Biliary excretion of mAbs has been reported only for
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➢ Therefore, total clearance (CL) does usually not comprise
renal or biliary clearance.
➢ Across mAbs, clearance estimates range from about 11 to
almost 400 mL/h.
Drug Interaction Studies
➢ mAb drugs do not undergo classical metabolic reactions
involving the super family of cytochrome P450 (CYP)
isoenzymes
➢ The clinical development of mAbs therefore usually does not
include in-vitro or in-vivo drug–drug interaction studies with
CYP substrates, inducers or inhibitors.
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OLIGONUCLEOTIDES
➢ Oligonucleotides are short DNA or RNA molecules, oligomers,
that have a wide range of applications in genetic
testing, research, and forensics.
➢ Commonly made in the laboratory by solid-phase chemical
synthesis, these small bits of nucleic acids can be manufactured
as single-stranded molecules with any user-specified sequence,
and so are vital for artificial gene synthesis, polymerase chain
reaction (PCR), DNA sequencing, library construction and
as molecular probes.
➢ In nature, oligonucleotides are usually found as small RNA
molecules that function in the regulation of gene expression
(e.g. microRNA), or are degradation intermediates derived from
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➢ Oligonucleotides are characterized by the sequence of
nucleotide residues that make up the entire molecule.
➢ The length of the oligonucleotide is usually denoted by “-mer”
(from Greek meros, “part”). For example, an oligonucleotide of
six nucleotides (nt) is a hexamer, while one of 25 nt would
usually be called a “25-mer”. Oligonucleotides readily bind, in
a sequence-specific manner, to their respective complementary
oligonucleotides, DNA, or RNA to form duplexes or, less
often, hybrids of a higher order.
➢ This basic property serves as a foundation for the use of
oligonucleotides as probes for detecting DNA or RNA.
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➢ Examples of procedures that use oligonucleotides
include DNA microarrays, Southern blots, ASO
analysis, fluorescent in situ hybridization (FISH), PCR, and
the synthesis of artificial genes.
➢ Oligonucleotides are also indispensable elements in antisense
therapy.
➢ Oligonucleotides composed of 2′-deoxyribonucleotides
(oligodeoxyribonucleotides) are fragments of DNA and are
often used in the polymerase chain reaction, a procedure that
can greatly amplify almost any small amount of DNA.
➢ There, the oligonucleotide is referred to as a primer,
allowing DNA polymerase to extend the oligonucleotide and
replicate the complementary strand.
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➢ Oligonucleotides are chemically synthesized using building
blocks, protected phosphoramidites of natural or chemically
modified nucleosides or, to a lesser extent, of non-nucleosidic
compounds.
➢ The oligonucleotide chain assembly proceeds in the direction
from 3′- to 5′-terminus by following a routine procedure
referred to as a “synthetic cycle”.
➢ Completion of a single synthetic cycle results in the addition of
one nucleotide residue to the growing chain.
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Vaccines
➢ Vaccines Currently, vaccines are not only developed against
infectious diseases, but also against drug abuse (nicotine,
cocaine) and against allergies, cancer and Alzheimer’s
disease.
➢ Despite the success of conventional vaccines, there are still
many infectious diseases and other chronic diseases against
which no effective vaccine exists.
➢ In addition, the growing resistance to the existing arsenal of
antibiotics increases the need to develop vaccines against
common bacterial infections.
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➢ Although conventionally produced vaccines are generally
harmless, some of them may, rarely, contain infectious
contaminants.
➢ Vaccines whose active ingredients are recombinant antigens do
not carry this slight risk.
➢ Vaccines produced by recombinant DNA techniques have been
used to combat seasonal influenza virus and hepatitis A and B.
➢ The first vaccine against hepatitis B was made from plasma
derived from patients with chronic hepatitis B, and a
recombinant vaccine whose sole active ingredient is a
recombinant antigen has now replaced it.
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➢ Immunotherapy is a type of biological therapy. It aims to
enhance the body’s immune response, Biological therapies use
substances made from living organisms to treat disease.
➢ Immunotherapy is a treatment that strengthens the natural
ability of the patient’s immune system to fight foreign bodies.
➢ Instead of targeting the person’s foreign cells directly,
immunotherapy trains a person’s natural immune system to
recognize foreign cells and selectively target and kill them.
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Immunotherapy’s do this in one of two ways:
➢ By enabling the immune system to mount or maintain a
response
➢ By suppressing factors that prevent the immune response
There are many different types of immunotherapy
i. Immune checkpoint inhibitors
ii. Therapeutic cancer vaccines
iii. Adoptive T cell transfer
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GENE THERAPY
➢ Gene therapy is a novel treatment method which utilizes
genes or short oligonucleotide sequences as therapeutic
molecules, instead of conventional drug compounds.
➢ Gene therapy involves the introduction of one or more
foreign genes into an organism to treat hereditary or acquired
genetic defects.
➢ In gene therapy, DNA encoding a therapeutic protein is
packaged within a “vector”, which transports the DNA inside
cells within the body.
➢ The disease is treated with minimal toxicity, by the expression
of the inserted DNA by the cell machinery
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➢ There are several approaches for correcting faulty genes; the
most common being the insertion of a normal gene into a
specific location within the genome to replace a non
functional gene.
1. Somatic gene therapy
2. Germ line gene therapy
1. Somatic Gene Therapy:
➢ In somatic gene therapy, the somatic cells of a patient
are targeted for foreign gene transfer.
➢ In this case the effects caused by the foreign gene is
restricted to the individual patient only, and not inherited
by the patient’s offspring or later generations.
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2. Germ Line Gene Therapy:
➢Here, the functional genes, which are to be integrated
into the genomes, are inserted in the germ cells, i.e.,
sperm or eggs.
➢Targeting of germ cells makes the therapy heritable
Gene Therapy Strategies
i. Gene Augmentation Therapy (GAT)
ii. Targeted Killing of Specific Cells
iii. Targeted Inhibition of Gene Expression
iv. Targeted Gene Mutation Correction
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GENE AUGMENTATION THERAPY (GAT)
➢ In GAT, simple addition of functional alleles is used to
treat inherited disorders caused by genetic deficiency of
a gene product, e.g. GAT has been applied to autosomal
recessive disorders
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TARGETED KILLING OF SPECIFIC CELLS
It involves utilizing genes encoding toxic compounds (suicide
genes), or prodrugs (reagents which confer sensitivity to
subsequent treatment with a drug) to kill the transfected/
transformed cells. This general approach is popular in cancer
gene therapies.
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Targeted Inhibition of Gene Expression
➢ This is to block the expression of any diseased gene or a new
gene expressing a protein which is harmful for a cell. This is
particularly suitable for treating infectious diseases and some
cancers.
Targeted Gene Mutation Correction
➢ It is used to correct a defective gene to restore its function
which can be done at genetic level by homologous
recombination or at mRNA level by using therapeutic
ribozymes or therapeutic RNA editing
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GENE THERAPY APPROACHES
1. Classical Gene Therapy
2. Non-classical gene therapy
1. Classical Gene Therapy
➢ It involves therapeutic gene delivery and their optimum
expression once inside the target cell.
2. Non-classical gene therapy
➢ It involves the inhibition of expression of genes associated
with the pathogenesis, or to correct a genetic defect and
restore the normal gene expression.
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METHODS OF GENE THERAPY
There are mainly two approaches for the transfer of
genes in gene therapy:
1. Ex vivo gene therapy
➢ In this mode of gene therapy genes are transferred to
the cells grown in culture, transformed cells are
selected, multiplied and then introduced into the
patient
2. In Vivo Gene Therapy
➢ In vivo method of gene transfer involves the transfer
of cloned genes directly into the tissues of the patient
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Advantages of Gene Therapy
➢ Gene therapy can cure genetic diseases by addition of gene or
by removal of gene or by replacing a mutated gene with
corrected gene.
➢ Gene therapy can be used for cancer treatment to kill the
cancerous cells.
➢ Gene expression can be controlled.
➢ Therapeutic protein is continuously produced inside the body
which also reduces the cost of treatment in long term.
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REFERENCES
1. Brahmankar.D.M, Jaiswal.B.sunil, Biopharmaceutics and
pharmacokinetics–Atreatise, vallabh prakashan, Delhi,2005.
2. Pharmacokinetics and Pharmacodynamics of Biotech Drugs
Edited by Bernd Meibohm, 2006 WILEY-VCH Verlag
GmbH & Co. KGaA, Weinheim, Germany.
3. Leon Shargel, Andrew B.C. yu, Applied Biopharmaceutics
& Pharmacokinetics, Seventh Edition.
4. http;//Google.co.in/NPTEL – Bio Technology – Genetic
Engineering & Applications, Joint initiative of IITs and IISc
– Funded by MHRD.
5. http;//Google.co.in/Mc Graw Hills/access pharmacy/Applied
Pharmacokinetics and Pharmacodynamics.
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THANK YOU…
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