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Presented by
Maan Singh
M.Pharm(Pharmaceutics)
(Dept. of Pharmaceutical Science)
BBAU Lucknow
1
2
CONTENT
 Introduction
 Why is pharmacogenetics a good approach ?
 Goals of Pharmacogenetics
 How does genetic variation affect drug effect?
 Major drugs ineffective for many
 Advantages of pharmacogenetics
 Limitations Of Pharmacogenetics
 Role of Pharmacogenetics in Pharmaceutical Industry
 Roles of Pharmacists
 Pharmacogentics Labelling
 What is to come for future application?
 Hope For The Future
 Conclusion
 References
INTRODUCTION
PHARMACOGENETICS = Pharma and genetics
 Pharma the Greek word i.e. PHARMACON, related to
Drugs.
Genetics related to genes / genome
 The study of the genetic basis for variation in drug
response
3
 The word ‘pharmacogenetics’ was first coined by Vogel of
Heidelberg, in 1959
 Defined as the science of determining the genetic differences
on metabolic pathways which can affect individual responses
to drugs
 Pharmacogenetics is generally referred to study or
investigation of genetic variations leading to varied
responses to pharmaceutical products
4
Conti..
Why is pharmacogenetics a good approach ?
 Drugs can be dangerous.
 Drugs are expensive.
 Genetics provide a priori information
5
Goals of Pharmacogenetics:-
 Maximize drug efficacy
 Predicts patient
 Minimize drug toxicity
 Aid in new drug development
6
Polymorphism :- A polymorphism is a variation in the DNA
sequence that is present at an allele frequency of 1% or greater
in a population.
Genetic Variant:
 Single nucleotide polymorphisms (SNPs)
7
SNPs
single nucleotide polymorphism (SNP), is a variation in a single
nucleotide that occurs at a specific position in the genome, where each
variation is present to some appreciable degree within a population
(e.g. >1%).
8
How does genetic variation affect drug effect?
9
 5 % hospital admissions
 10% hospitalized patients experience them
 106,000 deaths and 2.2 million serious events
caused by adverse drug reactions (ADRs) in
the US each year (Lazarou 1998)
 4th – 6th leading cause of death in the US for
hospitalized patients
 May lead to drug being withdrawn from the
market
Adverse drug reaction (ADR)
10
11
 Women have better response to serotonin reuptake inhibitor
antidepressants (SSRIs)
 Some anti-anxiety medications have better effect on men
than women.
 Narcotic pain relievers
 Beta-adrenergic blocking agent
 Angiotensin II inhibitor
 Combined treatment with hydralazine + isosorbine
EXAMPLES
12
Pharmacogenetics and Drug Development:-
 The major determinants of success of a new drug compound,
 viz safety and efficacy,
 have become more predictable, with the advent of
pharmacogenetics.
 Pharmacogenetics can identify new targets
 Pharmacogenetics may identify subsets of patients who will
have a very high or a very low likelihood of responding to an
agent.
13
Advantages of pharmacogenetics:-
 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.
14
Limitations Of Pharmacogenetics
Complex targeting due to multiple gene
involvement
 Difficult and time consuming to identify small
variations in genes
 Interaction with other drugs and environment
to be determined
15
Pharmacogenetics has a threefold role in the
pharmaceutical industry including…
 Studying drug metabolism and pharmacological effects
 Predicting genetically determined adverse reactions (ADRs)
 Drug discovery and development and as an aid to planning
clinical trials
Role of Pharmacogenetics in Pharmaceutical Industry
16
 Pharmacogenetic discoveries to patient care
 Pharmacogenetics in clinical practice
 To provide individualized pharmaceutical care
Roles of Pharmacists
17
• PG data can be included in the
following label sections:
 Indications and Usage
 Dosage and Administration
 Contraindications
Pharmacogentics Labelling
 Warnings and Precautions
 Adverse Reactions
 Drug Interactions
 Use in Specific Populations
18
 More genotypic analysis and evaluations
What is to come for future application?
 In future all pharmacists, not just those involved in a
clinical or research setting,will probably need to understand
pharmacogenetic information for better drug selection.
 Investigation of multiple enzyme and
transporters and receptors
 Each patient’s history, physical condition, and gender, must
be considered when prescribing drugs.
19
Patient
gets sick
Patient goes to
Dr.
Dr. checks the
symptoms
Dr. performs various tests
(Blood, urine, biopsy,
bone marrow, saliva,
stool, hair. Etc.)
Dr. Determines causes
of sickness
Based on Patient’s genes,
Dr. prescribes appropriate
drugs
Patient’s gets
better 20
CONCLUSION
 The potential utility of pharmacogenetics
to optimize drug therapy is great.
 Advantage They need only be conducted once
during an individual's lifetime.
 With continued incorporation of pharmacogenetics
into clinical trials, the important genes and
polymorphisms will be identified.
 Refinement of dosing in the context of drug
interactions and disease influences.
 More precise ‘personalised’ therapeutics for several
drugs and disorders.
21
1. The pharmacological basis of Therapeutics ,goodman &
gilman,12th edition,2011,page 145-165.
2. Rang & dale’s pharmacology,7th edition,2012,page 132-137.
3. Methods in molecular biology,vol 448,pharmacogenomics in
drug Discovery & development,gary Hardiman,page 21-29.
REFERENCES;
4. S.N. Enrico Mini; Pharmacogenitics:Implementing
personalised medicine; Department of pharmacology,
University of florence, florence, Italy. 2009, page no. 17-24
5. Patil Jagadevappa; Pharmacogenetics and
Pharmacogenomics: A Brief Introduction; Volume 3rd; VT’s
Shivajirao S Jondhle College of Pharmacy, Asangaon, Dist.
Thane-421 601, Maharashtra, India, 2015
22
Thank You for
your Attention
23

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Phrmacogentics

  • 1. Presented by Maan Singh M.Pharm(Pharmaceutics) (Dept. of Pharmaceutical Science) BBAU Lucknow 1
  • 2. 2 CONTENT  Introduction  Why is pharmacogenetics a good approach ?  Goals of Pharmacogenetics  How does genetic variation affect drug effect?  Major drugs ineffective for many  Advantages of pharmacogenetics  Limitations Of Pharmacogenetics  Role of Pharmacogenetics in Pharmaceutical Industry  Roles of Pharmacists  Pharmacogentics Labelling  What is to come for future application?  Hope For The Future  Conclusion  References
  • 3. INTRODUCTION PHARMACOGENETICS = Pharma and genetics  Pharma the Greek word i.e. PHARMACON, related to Drugs. Genetics related to genes / genome  The study of the genetic basis for variation in drug response 3
  • 4.  The word ‘pharmacogenetics’ was first coined by Vogel of Heidelberg, in 1959  Defined as the science of determining the genetic differences on metabolic pathways which can affect individual responses to drugs  Pharmacogenetics is generally referred to study or investigation of genetic variations leading to varied responses to pharmaceutical products 4 Conti..
  • 5. Why is pharmacogenetics a good approach ?  Drugs can be dangerous.  Drugs are expensive.  Genetics provide a priori information 5
  • 6. Goals of Pharmacogenetics:-  Maximize drug efficacy  Predicts patient  Minimize drug toxicity  Aid in new drug development 6
  • 7. Polymorphism :- A polymorphism is a variation in the DNA sequence that is present at an allele frequency of 1% or greater in a population. Genetic Variant:  Single nucleotide polymorphisms (SNPs) 7
  • 8. SNPs single nucleotide polymorphism (SNP), is a variation in a single nucleotide that occurs at a specific position in the genome, where each variation is present to some appreciable degree within a population (e.g. >1%). 8
  • 9. How does genetic variation affect drug effect? 9
  • 10.  5 % hospital admissions  10% hospitalized patients experience them  106,000 deaths and 2.2 million serious events caused by adverse drug reactions (ADRs) in the US each year (Lazarou 1998)  4th – 6th leading cause of death in the US for hospitalized patients  May lead to drug being withdrawn from the market Adverse drug reaction (ADR) 10
  • 11. 11
  • 12.  Women have better response to serotonin reuptake inhibitor antidepressants (SSRIs)  Some anti-anxiety medications have better effect on men than women.  Narcotic pain relievers  Beta-adrenergic blocking agent  Angiotensin II inhibitor  Combined treatment with hydralazine + isosorbine EXAMPLES 12
  • 13. Pharmacogenetics and Drug Development:-  The major determinants of success of a new drug compound,  viz safety and efficacy,  have become more predictable, with the advent of pharmacogenetics.  Pharmacogenetics can identify new targets  Pharmacogenetics may identify subsets of patients who will have a very high or a very low likelihood of responding to an agent. 13
  • 14. Advantages of pharmacogenetics:-  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. 14
  • 15. Limitations Of Pharmacogenetics Complex targeting due to multiple gene involvement  Difficult and time consuming to identify small variations in genes  Interaction with other drugs and environment to be determined 15
  • 16. Pharmacogenetics has a threefold role in the pharmaceutical industry including…  Studying drug metabolism and pharmacological effects  Predicting genetically determined adverse reactions (ADRs)  Drug discovery and development and as an aid to planning clinical trials Role of Pharmacogenetics in Pharmaceutical Industry 16
  • 17.  Pharmacogenetic discoveries to patient care  Pharmacogenetics in clinical practice  To provide individualized pharmaceutical care Roles of Pharmacists 17
  • 18. • PG data can be included in the following label sections:  Indications and Usage  Dosage and Administration  Contraindications Pharmacogentics Labelling  Warnings and Precautions  Adverse Reactions  Drug Interactions  Use in Specific Populations 18
  • 19.  More genotypic analysis and evaluations What is to come for future application?  In future all pharmacists, not just those involved in a clinical or research setting,will probably need to understand pharmacogenetic information for better drug selection.  Investigation of multiple enzyme and transporters and receptors  Each patient’s history, physical condition, and gender, must be considered when prescribing drugs. 19
  • 20. Patient gets sick Patient goes to Dr. Dr. checks the symptoms Dr. performs various tests (Blood, urine, biopsy, bone marrow, saliva, stool, hair. Etc.) Dr. Determines causes of sickness Based on Patient’s genes, Dr. prescribes appropriate drugs Patient’s gets better 20
  • 21. CONCLUSION  The potential utility of pharmacogenetics to optimize drug therapy is great.  Advantage They need only be conducted once during an individual's lifetime.  With continued incorporation of pharmacogenetics into clinical trials, the important genes and polymorphisms will be identified.  Refinement of dosing in the context of drug interactions and disease influences.  More precise ‘personalised’ therapeutics for several drugs and disorders. 21
  • 22. 1. The pharmacological basis of Therapeutics ,goodman & gilman,12th edition,2011,page 145-165. 2. Rang & dale’s pharmacology,7th edition,2012,page 132-137. 3. Methods in molecular biology,vol 448,pharmacogenomics in drug Discovery & development,gary Hardiman,page 21-29. REFERENCES; 4. S.N. Enrico Mini; Pharmacogenitics:Implementing personalised medicine; Department of pharmacology, University of florence, florence, Italy. 2009, page no. 17-24 5. Patil Jagadevappa; Pharmacogenetics and Pharmacogenomics: A Brief Introduction; Volume 3rd; VT’s Shivajirao S Jondhle College of Pharmacy, Asangaon, Dist. Thane-421 601, Maharashtra, India, 2015 22
  • 23. Thank You for your Attention 23

Editor's Notes

  1. There are so many drugs that can be toxic to our body if we administerd without proper knowledge of any drug, so to overcome this, we should have the proper knowledge about the genetics information of an individual person. There are so many Drugs, that are so expensive, and a poor patient can’t affords these medicine easily, and if we have a sufficient knowledge about the genetics informatiomn of an individual patient so we can prescribe the a desire drug according to patient gene response. And can avoid the multiple drugs that are not required to patient. Genetics provide a priori information by using this information we can targets the particular disease.
  2. Allele- each of two or more alternative forms of a gene that arise by mutation and are found at the same place on a chromosome
  3. Lets see an example, In 1998 a survey was held in US Its main aim to determine the serious and fetal ADR. In this data was collected from the year 1966 to 1996 (i.e around 30 years of data) and was found that 5% patient had an ADR before admitted to hospital and 10% patients experience ADR after hospitalization. We excluded errors in drug administration, non complience, overdose and therapeutics failures
  4. Women have better response to serotonin reuptake inhibitor antidepressants (SSRIs) like Prozac and Paxil, than to tricyclic antidepressants like Elavil and Tofranil; also more likely to develop depression due to low serotonin levels. 3 Women have better response to narcotic pain relievers than to non-narcotics. 4 Carvedilol (Coreg), a beta-adrenergic blocking agent used to lower blood pressure, is more effective in Africans than Caucasians. 5 Enalopril (Vasotec), an angiotensin II inhibitor to lower blood pressure, is more effective in Caucasians than Africans. 6 Heart failure combined treatment with hydralazine + isosorbine is more effective in Africans than Caucasians.
  5. 1- Pharmacists may play a key role in applying pharmacogenetic discoveries to patient care. 2- Pharmacists can take a lead in application of pharmacogenetics in clinical practice, since they are experts in pharmacokinetics and pharmacodynamics. 3- Some experts have suggested that pharmacists need access to patients' genetic information in order to provide individualized pharmaceutical care before they fill prescriptions.
  6. HOPE FOR THE FUTURE