M. Pharma 1st Sem, Drug Delivery System. Dept of Pharmaceutics.

1. PERSONALIZED MEDICINES
& CUSTOMIZED DRUG
DELIVERY SYSTEM
PRESENTED BY: FACILITATED TO:
Kushal S Tegginamani Dr. Anita Desai
M Pharm Ist Sem Professor
Dept of Pharmaceutics Dept of Pharmaceutics
HSK COP Bagalkote. HSK COP Bagalkote.
1

2. Contents:
Personalized Medicines:
 Introduction.
 Definitions.
 Pharmacogenetics.
 Categories of Patients for Personalized Medicines.
Customized drug delivery systems:
 Bioelectronics Medicines.
 3D printing of pharmaceuticals.
 Telepharmacy.
2

3. INTRODUCTION:
The last 20 years have seen the emergence of the concepts of P4 medicine, that
are:
o participatory medicine.
o personalized medicine.
o predictive medicine.
o preventive medicine.
• This has occurred mainly in parallel with the developments in clinical genetics,
artificial intelligence, and digital technology.
• P4 medicine is particularly based on the now almost ubiquitous nature of digital
technology, whether in terms of data collection, storage, and computing
capacities, or in terms of the development and use of algorithms.
Personalized Medicines:
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4. • It updates of gaining knowledge and information that is more specific, more
targeted, and more adapted to the pathology of a given person, and to be able to
analyze these data in an intelligible and useful form in order to be able to propose
personalized treatment and care.
• The promise of personalized medicine is that through better understanding of
pharmacogenomics and genetic profiling of patients especially involved in clinical
trails gives more valuable data to support treatments of individuals to respond to
medications and unlikely suffer adverse reactions.
• It is specified that “personalized medicine is being advanced through data
from the Human Genome Project,” highlighting the crucial importance of
genetics to this approach.
4

5. Definition:
• Personalized medicine: “is an emerging practice of medicine that uses an individual's genetic
profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease.
Knowledge of a patient's genetic profile can help doctors select the proper medication or
therapy and administer it using the proper dose or regimen”. As per the US National Human
Genome Research Institute.
• Genomics: Study of the entire set of genetic instructions found in a cell (DNA).
• Pharmacogenomics (PGx)- is the study of how a person’s genetic makeup affects that
individual’s response to medications. In doing this, it aims to develop a strategy to optimize
drug therapies. Data with respect to a patient’s genotype is used to try and maximize drug
efficacy while minimizing adverse drug effects and drug-drug interactions.
• Pharmacogenetics (PGt)- The study or clinical testing of genetic variation that assists in
individual patient’s differentiation response to drugs.
• Biomarker- is a characteristic that is objectively measured and evaluated as an indicator of
normal biologic processes, disease processes, or biological responses to a therapeutic
intervention.
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6. 1. WHAT IS PERSONALIZED MEDICINE?
Personalized medicine is an evolving field in which physicians use diagnostic
tests to determine which medical treatments will work best for each patient or
use medical interventions to alter molecular mechanisms that impact health. By
combining data from diagnostic tests with an individual’s medical history,
circumstances, and values, health care providers can develop targeted prevention
and treatment plans with their patients.
2. WHO DOES PERSONALIZED MEDICINE HELP?
Personalized medicine can guide patients toward prevention and treatment
strategies designed to ward off many diseases and conditions, including certain
cancers, rare genetic diseases, and some chronic and infectious diseases.
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7. 3. HOW DOES PERSONALIZED MEDICINE HELP PATIENTS?
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8. Currently, most physicians use “one size fits all” approach.
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9. Personalized medicines enables the selection of the right drug at the right dose for
the right PATIENT.
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10. Need for Personalized medicines:
• shift the emphasis in medicine from reaction to
prevention.
• predict susceptibility to disease.
• improve disease detection.
• customize disease-prevention strategies.
• prescribe more effective drugs.
• avoid prescribing drugs with predictable side effects.
• reduce the time, cost, and failure rate of
pharmaceutical clinical trials.
• eliminate trial-and-error inefficiencies that inflate
health care costs and undermine patient care.
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11. Pharmacogenomics:
• In pharmacogenomics, genomic information is used to study individual responses
to drugs. When a gene variant is associated with a particular drug response in a
patient, there is the potential for making clinical decisions based on genetics by
adjusting the dosage or choosing a different drug.
• Scientists assess gene variants affecting an individual's drug response the same
way they assess gene variants associated with diseases: by identifying genetic loci
associated with known drug responses.
 When studying drug action in individuals, researchers focus on two major
determinants:
i) How much of a drug is needed to reach its target in the body.
ii) How well the target cells, such as heart tissue or neurons, respond to the drug.
The scientific terms for these two determinants are pharmacokinetics and
pharmacodynamics, and both are critical considerations in the field of
pharmacogenomics.
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12. Pharmacokinetics:
Pharmacokinetics encompasses four processes: absorption, distribution, metabolism, and
excretion.
• Absorption usually refers to how a drug enters the bloodstream after a person takes a pill.
• Distribution describes where the drug travels after absorption and how much of the drug
reaches the target site.
• Metabolism refers to how the drug gets broken down in the body.
• excretion describes how drugs leave the body, whether by urine, bile, or, in some cases,
exhalation.
Pharmacodynamics:
Pharmacodynamics is the molecular action of a drug on its target, whether this is a cell surface
target (e.g., a receptor), an ion channel, or an intracellular target (e.g., an enzyme or
regulatory protein).
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13. 13

14. Pharmacogenetics:
• Pharmacogenetics blends important components of the disciplines of genetics and
pharmacology, and aims to describe the influence of inheritance on variable drug
response.
• This review provides an overview of the history and current status of
pharmacogenetics.
• The role of genetics in variable drug response is now firmly established. To apply
this information to the clinical setting, more sophisticated methods, such as a
multiple candidate gene approach, or genomic approaches, are likely to be needed.
• The clinical vision for pharmacogenetics is that genetic information might be used
to identify the drug(s) and dosages with the highest likelihood for benefit and the
lowest risk for harm in an individual patient.
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15. As outlined in this, it is recognized that differences in either PK or PD can lead to
variable drug efficacy or toxicity risk.
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16. Clinical potential of pharmacogenetics. Patients with the same empirical diagnosis (e.g.
hypertension, leukemia, etc.) are typically treated in the same manner, although their
responses to drug therapy will not be the same. Pharmacogenetics has the potential to
provide a tool for predicting those patients who are likely to have the desired response to
the drug, those who are likely to have little or no benefit and those at risk for toxicity.
This would allow tailored therapy that should reduce adverse reactions to drugs and
increase efficacy rates.
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17. 1. Abacavir (Ziagen)
 Nucleoside analog reverse transcriptase inhibitor (NRTI) used to treat HIV and
AIDS first approved in 1998.
 Subsequent studies showed that patients who carry the HLA-B*5701 allele were
at high risk for hypersensitivity to abacavir, due to this allele being strongly
associated with a single-nucleotide polymorphism at the HLA-B*5701 locus.
 The label was changed to recommend pre-therapy screening for the HLA-B*5701
allele and the use of alternative therapy in subjects with this allele.
17

18. 2.Trastuzumab (Herceptin)
 Human Epidermal Growth Factor 2 (HER-2) positive tumors comprise 20-25% of
all breast cancers and are associated with worse clinical outcomes.
 It is a humanized monoclonal antibody designed to target the HER2 receptor
domain and today, HER2 testing is a routine part of clinical diagnosis for breast
cancer patients.
 Likewise, due to specific biomarker data, trastuzumab is a foundation therapy for
many patients with HER-2 positive breast cancer.
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19. 3.BRCA1 celebrity case report.
• In 2013, US actress Angelina Jolie underwent preventive double mastectomy, and
two years later, had her ovaries and fallopian tubes prophylactically removed as
well.
• A test had revealed that she had inherited a 'faulty' gene, BRCA1, that strongly
increased her risk of developing breast and ovarian cancer.
• Harmful mutations in the BRCA genes cause cancer down generations, and
research has shown that a female BRCA1 carrier has a 60–90 %chance of
developing breast cancer and a 40–60 % chance of ovarian cancer.
• Surgery – although not the only option – may significantly reduce the cancer risk
such women face.
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20. Advantages of pharmacogenomics:
 To predict a patient’s response to drugs
 To develop “customized” prescriptions
 To minimize or eliminate adverse events
 To improve efficacy and patient compliance
 To improve rational drug development
 Pharmacogenetic test need only be conducted once during the life time.
 To improve the accuracy of determining appropriate dosage of drugs, To screen
and monitor certain diseases
 To develop more powerful, safer vaccines
 To allow improvements in drug discovery and development.
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21. • Limitations of Pharmacogenomics:
1. Complexity of finding gene variations that affect drug response.
• Millions of SNPs must be identified and analysed to determine their involvement in drug
response
2. Confidentiality, privacy and the use and storage of genetic information
3. Educating healthcare providers and patients
• Complicates the process of prescribing and dispensing drugs
• Physicians must execute an extra diagnostic step to determine which drug is best suited to
each patient
4. Disincentives for drug companies to make multiple pharmacogenomic products
• Most pharmaceutical companies have been successful with their “one size fits all” approach
to drug development
• For small market- Pharmaceutical companies hundreds of millions of dollars on
pharmacogenomic based drug development. 21

22. Categories of patients for personalized medicine:
Patients are mainly classified depending upon the:
• Genetic polymorphism.
• Epigenetics and other factors.
• Cytochrome p450 genetic.
• Different Families of enzyme polymorphism.
22

23. 1. Genetic Polymorphism:
• Genetic polymorphism is a difference in DNA sequence among individuals,
groups or population.
• Variations in gene associated with pharmacokinetics and pharmacodynamic of
drug may result in toxic, altered, or no response.
• These variants can be used for developing a biomarkers for diagnosis and
therapeutics categorization of a particular diseases.
• The genome-wide association studies (GWAS) have discovered many genetics
variants related to different lethal diseases.
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24. 2. Epigenetic & other factors :
• Epigenetics factors such as age, sex, liver and kidney function, lifestyle previous
diseases and adverse reaction are also decides therapeutic response of drug.
• Old age patient have high risk of adverse reaction due to the poor rate of
physiology and metabolism.
• Gender-specific physiological difference such as a pregnancy and breastfeeding
also affect the outcome of treatment by a drug.
• A level of different hormones between a male and female has been observed,
which may cause different response to a drug in male and females.
• Environmental chemicals, drugs, and natural compounds can alter the efficacy of
the drug by drug-drug interactions or drug-herb interactions.
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25. 3.Cytochrome P450 genetic polymorphism:
• This group of enzymes as indicated earlier, responsible for metabolizing more than
30 types of enzyme.
• It can be determine how quickly and effectively these agents eliminated from
body.
• The CYP450 test can be used to determine dosing and effects of specific
antidepressant medications, anticoagulants such as warfarin, proton pump
inhibitors and number of other agents.
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26. 4. Different families of enzyme polymorphism:
A. Thiopurine Methyltransferase:
• An enzyme called thiopurine Methyltransferase breakdowns a chemotherapy drug
called thiopurine.
• It is used to treat leukemias and autoimmune disorders.
• Some people have genetic variations that prevent them from producing enzyme.
• As a result, thiopurine levels can build up in body, leading to severe toxicity.
• Therefore blood test can be used to check this variations before treatment begins.
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27. B. UGT1A1 enzyme :
• This enzyme determines how the body breakdown irinotecan, a chemotherapy
drug for treating colorectal cancer.
• In patient with deficiency of this enzyme the medication can build up to toxic
levels, possibly causing suppression of the bone marrow, infection, and even
death.
• Doctors can test for this genetic variation before treatment.
• Starts and then customize the dosage to prevent a toxic buildup of the drug.
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28. C. Dihydropyramidine dehydrogenase enzyme:
• The medication 5 - fluorouracil along with its related compounds one of the most
commonly used chemotherapy agents.
• Some people have a genetic variation that results in a decrease in the
Dihydropyramidine dehydrogenase enzyme, which is responsible for breaking
down 5-FU.
• As a result of this deficiency, some people may experience sever or even fatal
reaction to 5-FU.
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29. Customized drug delivery systems:
Introduction:
• Drug delivery systems that are designed to release the drug as per the need of the
individual or specific patient.
• Therapy with right drug at right dosing in the right patient.
• Ability to look at a patient on an individual basis will allow for a more accurate
diagnosis and specific treatment plan.
• Customized medicines are prepared based on each patient's medical history, needs,
genetics, health conditions and other factors.
• Genetic and metabolic data will allow drugs to be tailored to patients sub group.
The customized drug release profiles required will necessitate the use of multiple
types of technologies like extended release, sustained release and timed pulsatile
release.
• Much of the innovation will come from developing a better understanding of the
patient rather than the identification of new molecules.
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30. Definition:
• A customized drug delivery system refers to a method or technology designed
to deliver medication in a tailored manner based on individual patient
characteristics, such as genetics, metabolism, or disease state.
• These systems aim to optimize therapeutic outcomes while minimizing side
effects by delivering drugs at specific rates, times, or locations within the
body.
• It is also known as smart drug delivery.
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31. Advantages of customized drug delivery:
• Better matching patients to drugs instead of trial and error.
• Eliminate life-threating adverse reactions.
• Reduce cost of clinical trails by quickly identifying total failures and favorable
response for particular backgrounds.
• Improved efficacy of drugs.
• Dosage can be controlled for the patients who need lower doses or with the needs
of each individual patient.
• Any allergic creating ingredient can be skipped and a customized medicine can be
produced for a particular individual.
• One size fits all prescription medicines cannot meet, so customized medicines are
the only way to better health.
31

32. Customized drug delivery system
includes:
Bioelectronics Medicines.
3D printing of pharmaceuticals.
Telepharmacy.
32

33. Bioelectronics Medicines:
Definition:
• Bioelectronic medicine is devices that use electricity to regulate biological
processes, treat diseases, or restore lost functionality.
• BEMS can interact with excitable tissue in 3 distinct manners:
i. they can induce,
ii. block &
iii. sense electrical activity.
• Specifically, the peripheral nervous system will be at the center of this advance,
as the function it controls in chronic disease is extensive.
• The vision for bioelectronic medicines is one of the nano, implantable devices
that can be attached to individual peripheral nerves.
• Such devices will be able to decipher & modulate neural signaling patterns,
achieving a therapeutic effect that is targeted at the signal function of a specific
organ. 33

34. Components of Bioelectronic medicines:
• Electrode: Silicone based penetrating electrode, polymer based fine, time, life &
cuff electrode arrays, Complementary metal oxide semiconductor.
• Material: Noble metal, Alloys, Platinum, Platinum- iridium, Gold, Laser patterned.
• Gold or Platinum iridium foil (12 micrometre), lithographically patterned gold or
Platinum thin (300 nm), Films on polyamide or polyline, thermally evaporated
Ultra Thin (35 nm).
• Polymer: Polyimide 19-22, parylene 23-25 , polydimethyl siloxane (PDMS) 26-
28, liquid Crystal polymer 29-30, SU-8 photoresist 31, 32 , polyurethane 33, Sheet
or film (polyimide).
• Light: Emitting diodes for optogenetic stimulation, receiving elements for wireless
Power transfer, such as inductors, antennas and ultrasonic transducer.
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35. Mechanism of Bioelectronic Medicine:
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36. Eg.: For Bioelectrical medicine
Bioelectronics in Blind Disease: For the treating
retinal disease, bioelectronic medicine play
critical role. Bioelectronic medicine it’s a device
that is implanted in the retina, which is shown in
Fig, It includes a retinal prosthesis for restoring
vision to the blind, thereby significantly
improving patient’s quality of life. This
implantation treated blind disease.
36

37. Pacemakers:
• A pacemaker is a medical device that
generates electrical impulses delivered
by electrodes to contract the heart
muscles and regulate the electrical
conduction system of the heart.
• This wave has been a boon to patients by
regulating their heartbeats. Initially they
weren’t monitored electronically but
eventually due to the development in the
field of bioelectronics and biotechnology
they work perfectly, have given life to
thousands across the world, and make
complex problems concerned with the
heart simple.
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38. Applications of Bioelectronic medicines:
38

39. 3D printing of pharmaceuticals:
Definition:
• Medical 3D printing is increasingly deployed in both
clinical and research-based healthcare activities. It
involves the creation of physical replicas of anatomical
structures using 3D printing (also known as additive
manufacturing) processes.
• 3D printing can produce printlets (3D printed tablets) that
are individualized to a patient’s therapeutic requirements
(e.g. dosage, drug combination and drug release profiles)
and personal preferences (e.g. shape, size, texture and
flavor)​.
• A wide variety of medicines, ranging from rapidly
dissolving or dispersible formulations, controlled release
preparations, gastro-retentive tablets, suppositories,
minitablets through 3D printing.
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40. How does medical 3D printing work?
• To develop a patient-specific 3D print, digitization of a patient’s real anatomical
structures must first take place. This method leverages 3D scanning techniques
such as MRI, X-ray CT or 3D ultrasound to produce a volumetric image of the
anatomy.
• The images must be labelled, via a process called segmentation, to isolate
structures of interest and develop a 3D computer model. The techniques used here
are highly varied depending on the scanning modality, anatomical subject, and
image quality. Traditional approaches require significant time and expertise but
programs with advanced segmentation capability such as Simple ware software
can expedite this process.
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41. This is how it works:
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42. • DICOM from MRI scan of a liver imported into Simpleware ScanIP
42

43. 3D Printing machines of Pharmaceutical medicines:
1. Binder jet printing:
Binder jet printing:
43

44. 2. Dual extrusion 3D Printing:
44

45. 3. Fused Deposition Modelling:
45

46. Some images of 3D printed pills:
46

47. Advantages of 3D Printing:
• Flexible Design.
• Rapid Prototyping.
• Print on Demand.
• Strong and Lightweight Parts.
• Fast Design and Production.
• Minimising Waste.
• Cost Effective.
• Ease of Access.
• Environmentally Friendly
• Advanced Healthcare.
47

48. Disadvantages of 3D Printing:
• Limited Materials.
• Restricted Build Size.
• Post Processing.
• Part Structure.
• Reduction in Manufacturing Jobs.
• Design Inaccuracies.
• Copyright Issues.
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49. Telepharmacy:
• The provision of pharmaceutical care through the use of telecommunications and
information technologies to patients at a distance.
• Technologies included in telemedicine are videoconferencing, telephones,
computers, the Internet, fax.
• The telephone has changed from a dial-and-talk instrument to a multimedia access
tool. Medical devices are being attached to telephone lines to provide remote
monitoring and therapy.
49

50. Objectives of Telepharmacy:
• To make high quality healthcare available to traditionally under privileged
population.
• Save the time wasted by both the health care providers and patients in travelling.
• Case monitoring, home care and remote critical care.
• Reduce costs of medical care.
• Survey and track diseases.
50

51. Types Of Telepharmacy :
• Inpatient / Remote Order-Entry Review.
• Remote dispensing (retail/ outpatient/ discharge).
• IV admixture.
• Remote Counselling.
51

52. 1. Inpatient / Remote Order-Entry Review:
In the inpatient Telepharmacy, a pharmacist presents at a remote
location and performs remote order-entry services for an inpatient
pharmacy at a hospital.
Pharmacist at remote location reviews medication orders
prior to the hospital staff gives medication to the patient. Inpatient
Telepharmacy is beneficial for the hospitals, clinics and health systems
as it enables real-time mediation order examination and monitoring. In
this inpatient Telepharmacy pharmacist can provide 24/7 service.
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53. 2. Remote dispensing (retail/ outpatient/ discharge):
It is also called as retail community Telepharmacy. It is licensed physical
retailer pharmacy having certified pharmacy technician. A pharmacist
advises and monitors the technician, analyzes prescription and carries out
his or her responsibilities from a remote location via Videoconferencing or
telecommunication.
Many rural patients have difficulties in accessing pharmacy
services due to geographic location. This remote dispensing Telepharmacy
gives convenient accessibility to these patients.
These remote dispensing provides an opportunity to healthcare
organizations to start retail Telepharmacy sites in the areas where traditional
pharmacy may not be possible.
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54. 3. IV admixture :
IV admixture is outlined by The Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) as, “the preparation of
pharmaceutical product which needs the measured addition of a drug to
a 50ml or larger bag or bottle of intravenous fluid.”
By implementing the telepharmacy in iv admixture cleanroom,
hospital pharmacies may consume less time and can also save money. If
the iv admixture is reviewed by a pharmacist remotely, they can save the
time required to kit up and to get inside the cleanroom for reviewing the
solution.
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55. 4. Remote Counselling :
Pharmacist furnishes counselling to the patients through secure, live and
interactive video calls or via telecommunications.
Remote patient counselling gives potential for discharge
counselling, specialty counselling, etc.
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56. How to start a Telepharmacy?
1. Becoming familiar with the laws and rules.
a) General principles & first point of contact.
b) License Application National Council for
Prescription Drug Programs (NCPDP) and Drug
Enforcement Administration (DEA).
c) Third Party Reimbursement.
2. Assess the need.
3. Develop community partners.
4. Secure a physical location.
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57. Advantages of Telepharmacy:
• Access to healthcare system.
• Patient Satisfaction.
• Minimal Shortage Of Pharmacists.
• Effective Patient Counselling.
• Economic Benefits.
Disadvantages of Telepharmacy:
• Practical Challenges.
• Pharmacy Regulation Laws.
• Security.
• Plenty Of Time, Effort and Money.
• Inability To Use Technology.
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58. References:
• Cyrille Delpierre, Thomas Lefèvre. Precision and personalized medicine: What
their current definition says and silences about the model of health they promote.
Implication for the development of personalized health. Front Sociol. 2023 Feb
21;8:1112159.
• Daan J.A. Crommelina, Gert Storm. Personalised medicine’ through ‘personalised
medicines’: Time to integrate advanced, non-invasive imaging approaches and
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5– 8.
• Moinak Banerjee. Is pharmacogenomics a reality? Challenges and oppurtunities
for India. Indian Journal of Human Genetics 2011 Volume 17 Supplement 1. S1-
S4.
• Michael Goldman, Christopher D. Smith. Pharmacogenomics and Personalized
Medicine. GENOMICS. Nature Education 1(1):194.
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59. • Personalized Medicine 101 - The Personalized Medicine Coalition.
https://www.personalizedmedicinecoalition.org
• Wolfgang Sade´e, Zunyan Dai. Pharmacogenetics/genomics and personalized
medicine. Human Molecular Genetics, 2005, Vol. 14, Review Issue 2. R207–
R214.
• Julie A. Johnson. Pharmacogenetics: potential for individualized drug therapy
through genetics. TRENDS in Genetics Vol.19 No.11 November 2003. 660-666.
• Nicole Scholz. Personalised medicine The right treatment for the right person at
the right time. EPRS | European Parliamentary Research Service. October 2015. 1-
8.
• https://www.scribd.com/document/516802728/Customised-drug-delivery.
• Suhyeon Kim, Seungho Baek. Wearable and implantable bioelectronics as eco-
friendly and patient-friendly integrated nano architectonics for next-generation
smart healthcare technology. EcoMat, John Wiley 04 August 2023.
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60. • Pharmaceutical laboratory website https://alphagenomix.com/ Alpha Genomix
Laboratories.
• Pharmaceutical laboratory website https://www.jax.org/ The Jackson Laboratory.
• Pharmaceutical laboratory website https://www.synopsys.com/glossary/what-is-
medical-3d-printing.html Synopsys.
• Abdul W Basit, Sarah J Trenfield. 3D printing of pharmaceuticals and the role of
pharmacy. THE ROYAL PHARMACEUTICAL SOCIETY'S OFFICIAL JOURNAL.30
March 2022.
• DAVID M, ANGARAN. Telemedicine and telepharmacy: Current status and future
implications. Vol 56 Jul 15 1999 Am J Health-Syst Pharm. 1405-1426.
• Arpana S. Karnvar, Dr. V. S. Kashikar. A Review on Telepharmacy services.
International Journal of Pharmaceutical Research and Applications. Volume 5, Issue 2,
pp: 619-623.
• Pharmaceutical laboratory website https://www.twi-global.com/technical-
knowledge/faqs/what-is-3d-printing TWI.
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