PERSONALIZED
MEDICINE& 3D PRINTING
PHARMACEUTICALS
AND TELEPHARMACY
Presented by
ASWINKUMAR A M
M.Pharmacy First Year,
Department of Pharmaceutics,
College of Pharmacy,
Madras Medical College,
Chennai-600003.
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CONTENT
➢ Personalized medicine
ⱷ Definition
ⱷ Advantages
ⱷ Applications
ⱷ Pharmacogenetics and pharmacogenomics
ⱷ Categories of Patients for Personalized Medicine
ⱷ Bio electronic Medicines
➢ 3D Printing of Pharmaceuticals
➢ Telepharmacy
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PERSONALIZED MEDICINE
➢Personalized medicine, sometimes referred to as precision
or individualized medicine.
➢Emerging field of medicine.
➢It often help to assess which medical treatments and
procedures will be best for each patient.
➢The progress in study of human diseases at molecular
level advances in molecular diagnostics and drug
development based on genomics, proteomics,
metabolomics and biomarkers.
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Cont….
➢ 1990 -Human genome project launched and – FDA approves first
personalized medicine(Trastuzumb) with a companion diagnostic,
for the treatment of HER2 positive breast cancer.
➢ 2000- Human Genome Project completed for first targeted therapies
for lung cancer, leukemia,HIV, and many other diseases.
DEFINITION:
➢ The term personalized medicine is described that the ability to offer “
The Right Drug to the Right Patient, for the Right Disease, at the
Right Time with the Right Doseˮ.
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Cont….
➢ Personalized medicine is based on individuals genetic profile to make
the best therapeutic choice by facilitating predictions about whether
that person will benefits from a particular medicine or suffer serious
side effects.
➢ Drugs are generally tested on a large population of people and the
average is response is noted and reported. This sort of evidence based
medicine(that is medical decision making based on empirical data)
relies on the law of averages.
➢ Personalized medicine, on the other hand, recognizes that no two
patients are alike.
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➢ Personalized medicine involves identifying,
Physiological information,
Genetic information,
Clinical information.
All this three information allows the predictions to be made
about a persons susceptibility of developing diseases, course of
diseases and its response to a treatment.
➢ Personalized medicine is not a genetic medicine. Because it only
examines the individual genes and their effects as they related to
biology and medicine.
➢ In personalized medicine we study about the DNA polymorphisms
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DNA POLYMORPHISM :
➢ It is the natural variations in our genes that plays a role in our risk of
getting or not getting certain diseases.
➢ The combination of this variations across several genes affects each
individual risk.
➢ DNA polymorphisms leads to detect the differences in, How the
drugs are absorbed, used and metabolized in the different patients.
GENES :
➢ It gives a rise to proteins that play key role in biological process.
➢ Malfunctioning of this leads to genetic diseases or syndrome. Such
disorders are termed as monogenic.
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ADVANTAGES OF PERSONALIZED MEDICINE
FOR PATIENTS
➢ Effective and specific therapies.
➢ Low risk of adverse effects.
➢ No time in lost with trial and ineffective drugs.
➢ Improvement of quality of life.
ADVANTAGES OF PERSONALIZED
MEDICINE FOR CLINICIANS
➢Avoidance in trial and error approach in selection of drugs.
➢Less complication of treatment and adverse effect of drugs
➢Advances in medicine and translation of new biotechnologies
in to clinical practice.
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PERSONALIZED MEDICINE
MECHANICS
➢ Natural variation(DNA polymorphisms) plays a role in our risk of
getting or not getting certain diseases.
➢ External factors such as,
Enviroment
Diet
Exercise can also determine an individual risk for diseases.
➢ Natural genetic variations can plays a major role in determining drug
efficacy.
➢ Variations in DNA can leads to differences in pharmacodynamic and
pharmacokinetic in the individual patient.
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BASIC TECHNOLOGIES USED FOR
DEVELOPING PERSONALIZED MEDICINE:
➢ Based on the patients individual genetic expression, the following
techniques are used to detect the best medication for the patient.
➢ Molecular diagnostics particularly Single Nucleotide Polymorphism
(SNP).
➢ Pharmacogenomics – the application of genomics( variations of
DNA as well as RNA) for drug discovery and development.
➢ Pharmacogenetics- concern the study of influence of genetic factors
on response to drugs.
➢Pharmacogenetics is being used to learn ahead of time what
the best drug or the best dose of a drug will be for a person.
Also called pharmacogenomics.
➢Biomarkers
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Cont…
BIO MARKERS:
➢ Biomarkers are utilized for stratifying patients into types and subtypes of disease,
determining the acute and chronic disease,and assesment of disease occurance.
➢ There are different roles played by a biomarkers based on different characteristics,
namely preventative, diagnostics, prognostics. This is used for specific diagnosis
and treatment.
➢ Examples : everything from blood pressure and heart rate to basic
metabolic studies and x-ray findings to complex histologic and genetic
tests of blood and other tissues. Biomarkers are measurable and do not
define how a person feels or functions
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Cont…
MOLECULAR DIAGNOSTICS:
➢ Use of diagnostic testing to understand the molecular mechanism of
an individual patient’s disease, will be pivotal in the delivery of safe
and effective therapy for many diseases in the future.
ROLE OF MOLECULAR DIAGNOSTICS:
➢ Early detection and selection of appropriate treatment.
➢ Integration of Molecular Diagnostics with therapeutics.
➢ Monitoring of therapy.
Nucleic acid isolation and quantification, PCR amplification,
sequencing, and STR analysis.
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PERSONALIZED MEDICINE
Understanding human
genome
identify genetic
information
Genetic information
specific to individual
No No trial &
Preselect
toxicity error
effective drug
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CATEGORIZES OF PATIENT FOR
PERSONALIZED MEDICINE
➢Age related
1.Adult patient
2.Elderly patient
➢Diseases related
➢Genetically determined susceptibility
➢Individual physiological status
➢Sex related
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PHARMACOGENETICS
INTRODUCTION:
➢ Pharmacogenetics into clinical practice has the potential to improve
efficacy and reduce toxicity, by choosing “the right drug for the right
patient in the right disease at the right dose”.
➢ Primaquine induced hemolysis in patients with G6PD (Glucose-6-
Phosphate Dehydrogenase ) deficiency, was the first
pharmacogenetic discovery.
➢ Wherein personalized medicine, it is described that the study of the
linkage between the individual’s genotype and individual’s ability to
metabolize a foreign compound.
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DEFINITION:
➢Pharmacogenetics is the study of genetic basis for variability in drug
response.
➢The effect of genetic variation on drug response, including
disposition(PK), safety, tolerability and efficacy(PD).
➢Pharmacogenetics helps to determine, What the right medicines is
for you,based on your own genes. So the physician can provide a
more appropriate dose. So the patient can receive better and safer
drugs.
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ROLE OF PHARMACOGENETICS IN DRUG
DEVELOPMENT
➢ Studying drug metabolism and pharmacological effects
➢ Predicting genetically determined adverse reactions (ADRs)
➢ Drug discovery and development and as an aid to planning
clinical trials
➢ Decrease costs and time to bring drug to market
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DIVISIONS OF PHARMACOGENETICS
➢ The pharmacokinetics of a drug can be altered by sequence variations
in drug-disposition genes.
➢ The pharmacodynamics of a drug can be changed by sequence
variations in drug-target genes. Drug-disposition
Pharmacogenetics
Pharmacogenetics
Drug-target
Pharmacogenetics
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DRUG-DISPOSITION PHARMACOGENETICS
➢ A drug’s disposition includes its absorption, metabolism, distribution, and
excretion (ADME).
➢ The plasma concentrations of the parent drug or its active metabolites may
be affected by a genetic polymorphism altering the function of a protein that
is involved in the disposition of a drug.
➢ For example, if a genetic polymorphism leads to lower activity of a
metabolizing enzyme, the plasma concentrations of the parent drug may
increase and plasma concentrations of metabolites may decrease. If only the
parent drug exhibits pharmacologic activity, the genetic polymorphism will
potentiate the drug response, including adverse drug reactions.
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Cont…
➢ If only the metabolites have pharmacologic activity, then the genetic
polymorphism may reduce the drug response.
Examples:
➢ Warfarin and CYP2C9 polymorphisms
➢ Tamoxifen and CYP2D6 polymorphisms
➢ Thiopurine drugs and Thiopurine S-methyltransferase (TPMT)
polymorphisms
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TAMOXIFEN AND CYP2D6
POLYMORPHISMS
➢ Tamoxifen is commonly used for breast cancer treatment.
➢ Endoxifen, a metabolite of tamoxifen, is 100 times more potent than
the parent drug as a selective estrogen receptor modulator and
exhibits about 7 times higher plasma concentrations than the other
active metabolites at steady state.
➢ CYP2D6 is involved in generating endoxifen from tamoxifen.
➢ CYP2D6 have been associated with variability in plasma
concentrations of endoxifen among individuals.
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DRUG-TARGET PHARMACOGENETICS
➢ Pharmacologic effects of drugs are exerted by modulating activities
of enzymes or receptors.
➢ Genetic polymorphisms of drug-target enzyme or receptor may alter
the drug response.
➢ Fewer genetic polymorphisms in pharmacodynamic genes have been
recognized by FDA, including…
ß1-adrenergic receptor gene polymorphisms (ADRß1) and ß-
blocker response
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ADRB1 AND ß-BLOCKER RESPONSE
➢ Ser49Gly and Arg389Gly are two common SNPs in ADRß1.
➢ It is hypothesized that hypertensive patients carrying Ser49 or
Arg389 would have greater reduction in blood pressure with ß-
blocker therapy.
➢ Several studies have found that hypertensive patients with
Ser49Arg389 had the greatest reduction in blood pressure with oral
metoprolol.
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BIO ELECTRONIC MEDICINES
INTRODUCTION
➢ Bio-electronic medicine has the potential to be superior to drugs in
terms of efficacy, cost and safety.
➢ Because, it directly modulates the natural language of the body’s
nervous systems—electrical impulses and action potentials.
DEFINITION
➢ A branch of science that deals with electronic control of physiological
function especially as applied medicine to compensate for defects of
the nervous system.
➢ Bio electronic medicines are ‘A tiny implanted device treating disease
by changing the electric pulses in nerves to and from specific organs’.
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HOW DOES BIO-ELECTRONIC MEDICINE
WORK?
➢ Consider that virtually all the cells in the body are directly or
indirectly controlled by neural input and that peripheral neural
circuits play a pivotal role in maintaining homeostasis.
➢ Physiological and molecular changes in the body are sensed and
informed to the central nervous system by the peripheral sensory
neural circuits , which in turn activates a motor response reinstating
the homeostasis in the target tissue.
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Cont…
➢ Neural signals mediating information about the biological activity of
each cell are transmitted.
➢ As electric information in the form of action potentials traveling
along axonal fibers to and from the innervated tissues and organs.
➢ Use of bio-electronic devices in a broad spectrum of disorders,
including traumatic brain injury, stroke, neurodegenerative disorders,
gastro – intestinal disorders, hemorrhage and inflammatory diseases.
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APPLICATIONS OF BIOELECTRONICS
➢ There are wide applications for bioelectronics as known till this day
and many more which are still to be invented to implement painless
cure in medical science…
PACEMAKERS
➢ Also called artificial pacemakers, have been a boon to patients by regulating
their heart beats.
➢ A pacemaker consists of a battery, a computerized generator, and
wires with sensors at their tips. (The sensors are called electrodes.)
➢ The battery powers the generator, and both are surrounded by a thin
metal box. The wires connect the generator to the heart.
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Cont…
➢ A pacemaker helps monitor and control the heartbeat.
➢ The electrodes detect the heart’s electrical activity and send data through the
wires to the computer in the generator.
➢ If the heart rhythm is abnormal, the computer will direct the generator to
send electrical pulses to the heart.
➢ The pulses travel through the wires to reach the heart.
➢ Newer pacemakers can monitor blood temperature, breathing, and other
factors.
➢ The pacemaker’s computer also records the heart’s electrical activity and
heart rhythm, doctor will use these recordings to adjust the pacemaker so it
works better for patient.
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BLOOD GLUCOSE METER
➢ A blood glucose meter is an electronic device for measuring the
blood glucose level.
➢ A relatively small drop of blood is placed on a disposable test strip
which interfaces with a digital meter.
➢ Within several seconds, the level of blood glucose will be shown on
the digital display.
➢ The ingredients of a typical test strip are as follows:
➢ 29% w/w glucose oxidase (from Aspergillus niger, a fungus), 20U/mg
➢ 32%w/w potassium ferriccyanide
➢ 39% w/w nonreactive ingredients
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Cont…
➢ On each strip, there are about 10 layers, including a stiff plastic base
plate, and other layers containing chemicals or acting as spacers.
➢ For instance, there is a layer containing two electrodes (silver or
other similar metal).
➢ There also is a layer of the immobilized enzyme, glucose oxidase,
and another layer containing microcrystalline potassium ferricyanide,
[K3Fe(CN)6].
➢ These layers are suitably separated by the spacers to allow a small
amount of blood to enter.
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Cont…
➢ When the end of a strip is touched to a droplet of blood (usually on a
fingertip), the blood flows in by capillary action.
➢ A digital display on the screen “counts down” the seconds till the
concentration of glucose is displayed.
CHEMICAL REACTION OF THE GLUCOSE SENSOR:
➢ The glucose in the blood sample reacts with the glucose oxidase to
form gluconic acid, which then reacts with ferricyanide to form
ferrocyanide.
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Cont…
➢ The electrode oxidizes the ferrocyanide, and this generates a current
directly proportional to the glucose concentration.
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3D PRINTING OF PHARMACEUTICALS
INTRODUCTION:
➢ Powder-liquid three-dimensional printing (3DP) technology was
developed at the Massachusetts Institute of Technology (MIT) in the
late 1980s as a rapid-prototyping technique.
➢ This technology uses an aqueous fluid to bind together multiple
layers of powder using a unique, patent-protected process to create a
wide range of products.
➢ 3D printing is expected to modernize medicine.
➢ The first 3D printed pill, an anti-epilepsy drug called Spritam, was
approved by the FDA.
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DEFINITION
➢ Three-dimensional (3D) printing is a manufacturing method in which
objects are made by fusing or depositing materials in layers to
produce a 3D object.
➢ This process involves 3D prototyping of layer by layer fabrication
(via Computer Aided Design- CAD) to formulate drug materials into
the desired dosage form.
➢ This process is also referred to as additive manufacturing (AM),
rapid prototyping (RP), or solid free-form technology.
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ADVANTAGES OF 3D PRINTING
➢Designing simple, cheap
➢Accurate, flexible
➢High production rates
➢Reduction of material wastages
➢Ability to achieve high drug loading (up to 1,000 mg) with much
desired precision and accuracy.
➢Applicable to broad types of pharmaceutical active ingredients
including poorly water soluble, peptides and proteins, as well as drug
with therapeutic narrow window.
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TYPES OF 3D PRINTING
Fabrication of 3D objects can be achieved through a number of
techniques,
➢ Inkjet based fabrication
➢ Laser based writing system
➢ zip dose
➢ Fused deposition modeling
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INKJET BASED FABRICATION
➢ Different combinations of active ingredients and excipients (ink) are
precisely sprayed in small droplets (via drug on demand) or
continuous jet method in varying sizes layer by layer into a non-
powder substrate.
➢ Powder based 3D printing that uses a powder substrate for the sprayed
ink, it solidifies into a solid dosage form.
➢ Ex: levofloxacin implants, acetaminophen tablet
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LASER BASED WRITING SYSTEM
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Based on the principle of photo-polymerisation, in
which the free radicals are released after the photo
initiator and UV light.
UV light is aided by baffles, axes x and y, to traverse
the surface of liquid resin, in order to accurately
represent the 3D model.
When a layer solidifies, the lifting platform descends
its position to the height of a new layer of liquid resin,
again beginning the procedure, until the manufacture
of the 3D product is finished in a layer by layer way.
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ZIP DOSE
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ZIP DOSE
➢ Aprecia developed the zipdose platform, which is designed to enable
delivery of high dose medications in a rapidly disintegrating form.
➢ It produces a product layer by layer without using compression forces,
punches or dies.
➢ First, a powder blend is deposited as a single layer. Then an aqueous
binding fluid is applied and interaction between the powder and
liquid bind these material together.
➢ This process is repeated several times to produce solid, yet highly
porous formulations, even at high dose loading.
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FUSED DEPOSITION MODELING
➢ The polymer of interest is melted and extruded through a movable
heated nozzle.
➢ The layer by layer ejection of the polymer is repeated along x-y-z
stage, followed by solidification to create a shape previously defined
by the CAD models.
➢ This process can be applied multiple dosage forms that apply
polymers as part of the framework such as implants, zero order
release tablets, multilayered tablets and fast dissolving devices.
➢ EX: 5-amino salicylic acid tablet
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Cont…
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MEDICAL APPLICATIONS OF 3D
PRINTING
The current medical uses of 3D printing can be organized into
several categories,
➢ Tissues and organ fabrication
➢ Creating prosthetics, implants
➢ Pharmaceutical research concerning drug discovery, delivery and
dosage forms.
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TELEPHARMACY
INTRODUCTION
➢ Rural communities have always had difficulty in recruiting health
professionals.
➢ It will be difficult to introduce the pharmacist activities into rural and
remote area, given the shortage of pharmacists.
➢ Indeed, the shortage in these areas has often resulted in the role of
providing pharmacy services to rural and remote communities being
shifted to doctors, nurses, indigenous and other healthcare workers.
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Cont…
➢ Tele-pharmacy delivers clinical pharmacy services and the
dispensing of a prescription at a remote location without the physical
presence of a pharmacist.
➢ Telepharmacy acts as a potential alternative to around-the clock on-
site pharmacist medication review for remote hospitals.
➢ This has been adopted by many healthcare institutions where 24-
hours pharmacy services are not available.
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➢ The topic of telepharmacy was first introduced at the January 35,
2000, at the North Dakota State Board of Pharmacy .
DEFINITION
➢ The National Association of Boards of Pharmacy defines as
“Telepharmacy that the provision of pharmaceutical care to patients
at a distance through the use of telecommunications and information
technologies”.
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CLINICAL BENEFITS OF TELEPHARMACY
➢Easy access to healthcare services
➢Economic benefits – one skilled pharmacist for multiple
sites
➢Patient satisfaction- Missing their appointments, they
didn’t want to go out of their home
➢Effective patient counselling – through webcam they
provide better privacy and longer duration of counselling.
➢Minimal scarcity of pharmacists – It addresses pharmacist
shortage in rural areas and improves patient access to
pharmacy services.
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DISADVANTAGES
More time, effort and money – Hardware, Software,
Connectivity and Operational cost
Security – Handling of privacy information about
patients
Reluctance to use technology
Continuity of care
Operational difficulties – limited high speed digital
connection
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HOW DOES TELEPHARMACY WORK?
Nurse/Healthcare professionals
(Patient prescription by fax)
Central pharmacist
(reviews & releases the appropriate items)
Nurse
(scans the bar code & verify the label)
Central pharmacist can visually monitor the technician’s work
(to ensure that the right medications have been
filled and dispensed)
Central pharmacist provides a two-way video consultation for the
patient
(to ensure that they understand the intended medication
use and administration)
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TYPES OF TELEPHARMACY MODELS
REMOTE CONSULTATION SITES:
➢ Prescriptions are prepared at the central pharmacy and are delivered
to the rural sites.
➢ Audio and video computer links are used to deliver patient counseling and
education.
HOSPITAL TELEPHARMACY
Hospital pharmacist in urban reviews processes and verifies the
prescription that are issued and electronically sent from rural
hospitals.
Using ADM delivers drugs and at the rural end , Nurses double
checks the label and deliver to patients.
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ADMS (AUTO DISPENSING MECHINES):
➢ ADM or automated drug storage and dispensing device used in the
health care settings like hospitals and nursing home.
➢ Pharmacist at a central location upon receiving drug order
(electronically or by fax).
➢ confirms the patient profile.
➢ conducts proper drug utilization review, and finally instructs the
ADM to release the medication with the help of audio and video
computer links, patient counseling is then conducted.
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REFERENCES
➢Chart Pack value of Personalized Medicine Spring 2015
➢ Telepharmacy: a pharmacist’s perspective on the clinical benefits and
challenges published in Integrated Pharmacy Research and Practice
➢ www.ncbi.nlm.nih.gov.in
➢ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1885075
➢http://www.medscape.com/viewarticle/590270
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Cont…
➢The future of dosage form: a brief review published in
world journal of pharmaceutical research.
➢Applications of 3D Printing in BioMedical Engineering
PPT by Debanjan Parbat, School of Bioscience &
Engineering, Jadavpur University, Kolkata-32
➢Pharmacogenetics by Dr.Sourav Chakrabarty
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