This document discusses pharmacogenetics and pharmacogenomics. It begins with definitions of pharmacogenetics, pharmacogenomics, and personalized medicine. It then discusses factors that affect genomic analysis like copy number variation, pathways, mutation spectra, and methylation. The document outlines some of the complexities in pharmacogenetic studies including issues at the pharmacokinetic and pharmacodynamic levels, heterozygous and homozygous states, multiple alleles, and gene-environment interactions. It also discusses disadvantages of study designs, inconsistencies in clinical applications, and challenges with pharmacogenomic testing, credibility, consent, privacy, insurance, and other social issues.
This document discusses personalized medicine and how considering individual patient characteristics can help improve treatment outcomes. It makes the following key points:
1. Current "one-size-fits-all" drug treatment approaches do not account for individual differences and can lead to unsatisfactory response rates, increased costs, and safety issues.
2. Personalized medicine aims to use a patient's demographics, medical history, and molecular information to better define therapies through an integrated approach of diagnostics and therapeutics called "theranostics".
3. A personalized approach that considers a patient's genetics, metabolism, concurrent diseases and environment factors can help achieve improved therapeutic outcomes by providing tailored treatment.
This document discusses the integration of pharmacogenomics into clinical trials. It defines pharmacogenomics as investigating drug responses based on genes, with the goal of predicting side effects and making personalized drug therapy. The causes of using pharmacogenomics in clinical trials include increasing drug failures, costs, and complex diseases. Pharmacogenomics can contribute to innovation in drug discovery and development by allowing targeted drugs tailored to individuals. However, challenges include a lack of standard methods and high costs. Overall, pharmacogenomics holds promise for the future by enabling precision medicine through rigorous research.
Personalized Medicine: Current and Future Perspectives Personalized Medicin...MedicineAndHealth
The document discusses personalized medicine, including its definitions, current state, and future perspectives. It provides examples of personalized medicine like warfarin dosing and breast cancer risk assessment. It outlines key issues for stakeholders like payers, providers, developers, government, and consumers regarding pharmacogenomics testing, costs, access, and emerging ethical and policy concerns around privacy, informed consent, and potential for discrimination.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
Pharmacology for Physiotherapy Book By Padmaja Udaykumar Second Edition.Khalid Ghaznavi
Pharmacology for Physiotherapy Book
By Padmaja Udaykumar Second Edition.
This consists of a complete book version. I hope this will be helpful for you.
This document discusses the emerging field of personalized or tailored medicine. It begins with an introduction to personalized medicine, defining it as tailoring medical treatments to an individual's characteristics. The document then covers the history and driving factors behind personalized medicine. It discusses the goals and benefits of personalized medicine, as well as some limitations. Potential applications discussed include pharmacogenetics, pharmacometabonomics, and cancer management. Several examples of personalized cancer treatments and diagnostics are provided. The document emphasizes that a one-size-fits-all approach to medicine is often ineffective and can cause harm, whereas personalized medicine aims to provide each patient with the right treatment.
Pharmacogenomics is the study of how an individual's genetic inheritance affects their body's response to drugs. It combines knowledge of genetics with pharmacology to develop tailored treatments for individuals based on their genetic makeup. The goal is to understand how genetic variations influence drug metabolism and response in order to optimize drug efficacy and safety for each patient. Pharmacogenomics holds promise for more powerful and safer medications, better screening for disease, and improvements in the drug development process through a more personalized approach to medicine. However, challenges remain in fully realizing this potential due to the complexity of genetic variations and interactions.
The role of pharmacists in personalization of therapy in light of GlobalizationDalia A. Hamdy
This document discusses the role of pharmacists in personalizing therapy in light of globalization. It begins by outlining how globalization has impacted healthcare systems and introduced terms like medical tourism. It then defines precision medicine and pharmacogenomics, noting that the latter studies how genetic variations affect drug response. The document proposes that pharmacists can help implement precision medicine by initiating and monitoring therapy, considering special populations, and addressing drug-gene interactions. It acknowledges challenges like healthcare professional knowledge, technology/cost, and developing guidelines from pharmacogenomic research. Overall, the document advocates for pharmacists to utilize genetic testing and resources to tailor treatment based on patients' genetic profiles.
This document discusses personalized medicine and how considering individual patient characteristics can help improve treatment outcomes. It makes the following key points:
1. Current "one-size-fits-all" drug treatment approaches do not account for individual differences and can lead to unsatisfactory response rates, increased costs, and safety issues.
2. Personalized medicine aims to use a patient's demographics, medical history, and molecular information to better define therapies through an integrated approach of diagnostics and therapeutics called "theranostics".
3. A personalized approach that considers a patient's genetics, metabolism, concurrent diseases and environment factors can help achieve improved therapeutic outcomes by providing tailored treatment.
This document discusses the integration of pharmacogenomics into clinical trials. It defines pharmacogenomics as investigating drug responses based on genes, with the goal of predicting side effects and making personalized drug therapy. The causes of using pharmacogenomics in clinical trials include increasing drug failures, costs, and complex diseases. Pharmacogenomics can contribute to innovation in drug discovery and development by allowing targeted drugs tailored to individuals. However, challenges include a lack of standard methods and high costs. Overall, pharmacogenomics holds promise for the future by enabling precision medicine through rigorous research.
Personalized Medicine: Current and Future Perspectives Personalized Medicin...MedicineAndHealth
The document discusses personalized medicine, including its definitions, current state, and future perspectives. It provides examples of personalized medicine like warfarin dosing and breast cancer risk assessment. It outlines key issues for stakeholders like payers, providers, developers, government, and consumers regarding pharmacogenomics testing, costs, access, and emerging ethical and policy concerns around privacy, informed consent, and potential for discrimination.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
Pharmacology for Physiotherapy Book By Padmaja Udaykumar Second Edition.Khalid Ghaznavi
Pharmacology for Physiotherapy Book
By Padmaja Udaykumar Second Edition.
This consists of a complete book version. I hope this will be helpful for you.
This document discusses the emerging field of personalized or tailored medicine. It begins with an introduction to personalized medicine, defining it as tailoring medical treatments to an individual's characteristics. The document then covers the history and driving factors behind personalized medicine. It discusses the goals and benefits of personalized medicine, as well as some limitations. Potential applications discussed include pharmacogenetics, pharmacometabonomics, and cancer management. Several examples of personalized cancer treatments and diagnostics are provided. The document emphasizes that a one-size-fits-all approach to medicine is often ineffective and can cause harm, whereas personalized medicine aims to provide each patient with the right treatment.
Pharmacogenomics is the study of how an individual's genetic inheritance affects their body's response to drugs. It combines knowledge of genetics with pharmacology to develop tailored treatments for individuals based on their genetic makeup. The goal is to understand how genetic variations influence drug metabolism and response in order to optimize drug efficacy and safety for each patient. Pharmacogenomics holds promise for more powerful and safer medications, better screening for disease, and improvements in the drug development process through a more personalized approach to medicine. However, challenges remain in fully realizing this potential due to the complexity of genetic variations and interactions.
The role of pharmacists in personalization of therapy in light of GlobalizationDalia A. Hamdy
This document discusses the role of pharmacists in personalizing therapy in light of globalization. It begins by outlining how globalization has impacted healthcare systems and introduced terms like medical tourism. It then defines precision medicine and pharmacogenomics, noting that the latter studies how genetic variations affect drug response. The document proposes that pharmacists can help implement precision medicine by initiating and monitoring therapy, considering special populations, and addressing drug-gene interactions. It acknowledges challenges like healthcare professional knowledge, technology/cost, and developing guidelines from pharmacogenomic research. Overall, the document advocates for pharmacists to utilize genetic testing and resources to tailor treatment based on patients' genetic profiles.
This document discusses the use of pharmacogenomics for personalized medicine. It defines key terms like pharmacogenomics and pharmacogenetics. It describes how genetic variations can be identified and linked to differences in drug response and phenotypes. Specific examples are given of actionable genotypes for warfarin and codeine metabolism. Challenges and opportunities for further research in implementing pharmacogenomics in clinical practice are also outlined.
The document discusses personalized medicine and how pharmacogenetics can enable more effective and targeted treatment by accounting for genetic factors that influence individual drug responses. It notes that most treatments currently take a "one-size-fits-all" approach, but genetics can account for up to 95% of variability in drug response. Pharmacogenetic testing can predict treatment outcomes, prevent adverse reactions, improve adherence by reducing side effects, and optimize healthcare spending by guiding more effective prescribing for individual patients. The document argues this patient-centric approach can lead to better health outcomes compared to current trial-and-error prescribing methods.
This document discusses personalized medicine (PM), which aims to provide customized treatment and care based on a patient's genetic profile. PM considers how genetic variations affect an individual's response to medications and susceptibility to diseases. The document outlines key benefits of PM, such as improved medication selection and safer dosing to minimize adverse reactions. It also discusses some current genetic tests used in PM, such as tests for enzymes involved in drug metabolism. Overall, the document presents PM as a promising approach that may enable more effective, targeted treatment tailored to individual patients.
Personalized medicine (PM) aims to individualize treatment based on a person's genes, environment, and lifestyle. It involves analyzing a person's genetic, genomic, and clinical information to make predictions about disease susceptibility, progression, and best treatment options. PM is not just about genetics but also considers natural variations in how individuals metabolize and respond to drugs. Through molecular analysis of biomarkers, PM can classify disease subtypes and subgroups that respond differently to therapies. The goals of PM are to enable more informed healthcare decisions, improve outcomes through targeted therapies, reduce side effects, focus on prevention over reaction, allow for earlier intervention, and reduce costs through a more personalized approach.
The document discusses the role of genomics in pharmacogenomics and drug development. It defines key terms like pharmacogenomics and pharmacogenetics. It explains how genomics technologies can help optimize drug efficacy and minimize toxicity by identifying genetic variations that influence individual drug responses. Genomic information from the human genome project can aid drug target identification and reduce bottlenecks in development. Single nucleotide polymorphisms are discussed as the most common genetic variations affecting drug metabolism. The applications of pharmacogenomics in precision medicine to improve drug safety and efficacy are summarized.
Human variation results from interactions between genes and the environment. Personalised medicine aims to tailor medical treatments to subgroups based on biological characteristics like genetics, environment, and immune factors. While this approach holds promise, challenges include accurately classifying human variability and developing reliable diagnostic tests. Widespread application also depends on reducing genome sequencing costs and increasing understanding of how genetic data translates to clinical applications. Overall, personalised medicine may improve outcomes but also raises issues regarding access, psychological impacts, and targeting prevention efforts.
Personalized medicines aim to tailor medical treatment to an individual patient's characteristics, needs, and preferences. This involves considering factors like a patient's DNA, environmental exposures, stress levels, and diet to identify the treatment that will cure their disease without side effects. Personalized medicines can help physicians choose therapies based on a patient's biological information from pharmacogenomics to improve accuracy, efficacy, and compliance compared to traditional one-size-fits-all approaches. Key goals are minimizing wasted drugs and preventing adverse reactions by predicting dosing and treatment responses.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
This document discusses pharmacogenomics, which is the study of how an individual's genetic makeup affects their response to drugs. It explains that people can metabolize and respond to drugs differently due to genetic variations. The goal of pharmacogenomics is to optimize drug therapy for each individual by selecting the right drug, dose, and time based on their genotype to maximize effectiveness and minimize side effects. It outlines how variations can influence whether receptors are present to bind drugs, other physiological traits, and how the body processes drugs through absorption, distribution, metabolism and excretion.
Joseph Levy MedicReS World Congress 2013 - 2MedicReS
This document discusses challenges in designing pharmacogenomics clinical trials. It provides an overview of pharmacogenomics and different types of pharmacogenomics studies. It then discusses three common clinical trial designs - subgroups analysis design, enrichment design, and genotype-guided design - and their advantages and disadvantages. Key challenges in pharmacogenomics clinical trials include small sample sizes for subgroups, possible confounding and selection biases, and statistical power issues. Prospective clinical trials are needed to validate predictive biomarkers and assess clinical utility of genotype-guided treatments.
Personalized medicine aims to provide the right drug to the right patient at the right time and dose based on their genetic profile. It enables more effective medicines with fewer side effects. Benefits include better drug delivery through avoiding trial and error, reduced costs from quickly identifying clinical trial failures, and improved drug efficiency. Personalized medicine development relies on pharmacogenomics, which studies how genes affect drug response, and pharmacogenetics, which links genotypes to drug metabolism abilities. Factors like age, sex, disease, drug interactions, and genetic polymorphisms influence drug absorption and effects. 3D printing and telemedicine help enable customized drug delivery through remote dispensing and counseling.
Technologies like cheap genomic sequencing are enabling patients to receive entirely customized therapy based on their genetic, molecular, and metabolic makeup. Personalized medicine will both increase patient outcomes and decrease side effects and unwanted complications. Prominent considerations of the role of pharmacists in health care management include the distribution of drugs and supplies, delivering drug-related information, and consultation to meet the needs of patients and health team members so their role is also very prominent in personalized medicine in the future.
“The Evolution of Pharmaceutical Biotechnology – Science, Strategies, Products, and Regulations”
Shows the latest developments in pharmaceutical biotechnology and provides a broad overview of biotherapeutic & biosimilar regulations globally and in the EU
Pharmacogenomics is the study of how an individual's genetic inheritance affects their response to drugs. It uses genomic tools in traditional pharmacology to enable predictive and personalized medication. The first observations of genetic variations affecting drug response date back to the 1950s. Approximately 106,000 deaths and 2.2 million serious adverse drug reactions occur each year due to the fact that "one size does not fit all" when it comes to medications. Pharmacogenomic technologies like genotyping and protein sequencing are used today to study how variations in genes like CYP450 and TPMT that encode drug-metabolizing enzymes can impact drug efficacy and safety.
ACRI is a leading clinical research training institute in Bangalore.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
hi.friends this is my first slide presentation which contain the information about the PERSONALIZED MEDICINES.this is the future medicinal treatment so,I hope you people like my presentation.
The document discusses in silico drug discovery methods including identifying potential drug targets, generating pharmacophore models, screening compound databases, and analyzing top hits through molecular docking simulations. A drug discovery strategy is outlined involving primary and secondary screening to identify lead compounds. The work plan describes using AutoDock Vina to dock and rank compounds, selecting the top 14 hits, and analyzing their binding interactions with HIV proteases. Nilotinib, lopinavir, ergoloid, and zafirlukast were evaluated in more detail and found to have high binding affinity to the target proteins.
This document presents an overview of personalized medicine. It defines personalized medicine as tailoring medical treatment to an individual patient's characteristics, needs and preferences. Personalized medicine is needed because similar symptoms can indicate different illnesses, and medical interventions do not always work for all people. Pharmacogenomics, the study of how genetic factors affect a person's response to drugs, is a key area of personalized medicine. Knowing a patient's genetic profile allows doctors to determine the best treatment and dosing for that individual. The advantages of personalized medicine include reducing disease burden, focusing on prevention, and lowering healthcare costs. Disadvantages include potential incorrect diagnostic results and genetic variations not being fully understood.
This document discusses the importance and benefits of pharmacogenetic testing for physicians and their patients. It notes that pharmacogenetic testing can help physicians determine the right drug, dose, and timing for each individual patient to reduce adverse drug reactions and improve outcomes. Not utilizing this testing could open physicians up to legal liability issues. The document provides several case studies demonstrating how pharmacogenetic testing could have helped identify the right treatment for patients and avoided negative health consequences or legal risks for physicians. It also addresses the ease of testing, billing, and reimbursement to make the case for integrating pharmacogenetics into medical practice.
This document discusses pharmacogenetics and how genetic differences can influence drug response. It introduces key concepts like the human genome project, pharmacogenomic effects on drug metabolism and transport, and how genetic testing can help determine who will respond to or be toxic to specific drugs. The goal is to develop personalized medicine where a person's genetic makeup is used to optimize drug selection and dosing for safety and effectiveness.
This document discusses the use of pharmacogenomics for personalized medicine. It defines key terms like pharmacogenomics and pharmacogenetics. It describes how genetic variations can be identified and linked to differences in drug response and phenotypes. Specific examples are given of actionable genotypes for warfarin and codeine metabolism. Challenges and opportunities for further research in implementing pharmacogenomics in clinical practice are also outlined.
The document discusses personalized medicine and how pharmacogenetics can enable more effective and targeted treatment by accounting for genetic factors that influence individual drug responses. It notes that most treatments currently take a "one-size-fits-all" approach, but genetics can account for up to 95% of variability in drug response. Pharmacogenetic testing can predict treatment outcomes, prevent adverse reactions, improve adherence by reducing side effects, and optimize healthcare spending by guiding more effective prescribing for individual patients. The document argues this patient-centric approach can lead to better health outcomes compared to current trial-and-error prescribing methods.
This document discusses personalized medicine (PM), which aims to provide customized treatment and care based on a patient's genetic profile. PM considers how genetic variations affect an individual's response to medications and susceptibility to diseases. The document outlines key benefits of PM, such as improved medication selection and safer dosing to minimize adverse reactions. It also discusses some current genetic tests used in PM, such as tests for enzymes involved in drug metabolism. Overall, the document presents PM as a promising approach that may enable more effective, targeted treatment tailored to individual patients.
Personalized medicine (PM) aims to individualize treatment based on a person's genes, environment, and lifestyle. It involves analyzing a person's genetic, genomic, and clinical information to make predictions about disease susceptibility, progression, and best treatment options. PM is not just about genetics but also considers natural variations in how individuals metabolize and respond to drugs. Through molecular analysis of biomarkers, PM can classify disease subtypes and subgroups that respond differently to therapies. The goals of PM are to enable more informed healthcare decisions, improve outcomes through targeted therapies, reduce side effects, focus on prevention over reaction, allow for earlier intervention, and reduce costs through a more personalized approach.
The document discusses the role of genomics in pharmacogenomics and drug development. It defines key terms like pharmacogenomics and pharmacogenetics. It explains how genomics technologies can help optimize drug efficacy and minimize toxicity by identifying genetic variations that influence individual drug responses. Genomic information from the human genome project can aid drug target identification and reduce bottlenecks in development. Single nucleotide polymorphisms are discussed as the most common genetic variations affecting drug metabolism. The applications of pharmacogenomics in precision medicine to improve drug safety and efficacy are summarized.
Human variation results from interactions between genes and the environment. Personalised medicine aims to tailor medical treatments to subgroups based on biological characteristics like genetics, environment, and immune factors. While this approach holds promise, challenges include accurately classifying human variability and developing reliable diagnostic tests. Widespread application also depends on reducing genome sequencing costs and increasing understanding of how genetic data translates to clinical applications. Overall, personalised medicine may improve outcomes but also raises issues regarding access, psychological impacts, and targeting prevention efforts.
Personalized medicines aim to tailor medical treatment to an individual patient's characteristics, needs, and preferences. This involves considering factors like a patient's DNA, environmental exposures, stress levels, and diet to identify the treatment that will cure their disease without side effects. Personalized medicines can help physicians choose therapies based on a patient's biological information from pharmacogenomics to improve accuracy, efficacy, and compliance compared to traditional one-size-fits-all approaches. Key goals are minimizing wasted drugs and preventing adverse reactions by predicting dosing and treatment responses.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
This document discusses pharmacogenomics, which is the study of how an individual's genetic makeup affects their response to drugs. It explains that people can metabolize and respond to drugs differently due to genetic variations. The goal of pharmacogenomics is to optimize drug therapy for each individual by selecting the right drug, dose, and time based on their genotype to maximize effectiveness and minimize side effects. It outlines how variations can influence whether receptors are present to bind drugs, other physiological traits, and how the body processes drugs through absorption, distribution, metabolism and excretion.
Joseph Levy MedicReS World Congress 2013 - 2MedicReS
This document discusses challenges in designing pharmacogenomics clinical trials. It provides an overview of pharmacogenomics and different types of pharmacogenomics studies. It then discusses three common clinical trial designs - subgroups analysis design, enrichment design, and genotype-guided design - and their advantages and disadvantages. Key challenges in pharmacogenomics clinical trials include small sample sizes for subgroups, possible confounding and selection biases, and statistical power issues. Prospective clinical trials are needed to validate predictive biomarkers and assess clinical utility of genotype-guided treatments.
Personalized medicine aims to provide the right drug to the right patient at the right time and dose based on their genetic profile. It enables more effective medicines with fewer side effects. Benefits include better drug delivery through avoiding trial and error, reduced costs from quickly identifying clinical trial failures, and improved drug efficiency. Personalized medicine development relies on pharmacogenomics, which studies how genes affect drug response, and pharmacogenetics, which links genotypes to drug metabolism abilities. Factors like age, sex, disease, drug interactions, and genetic polymorphisms influence drug absorption and effects. 3D printing and telemedicine help enable customized drug delivery through remote dispensing and counseling.
Technologies like cheap genomic sequencing are enabling patients to receive entirely customized therapy based on their genetic, molecular, and metabolic makeup. Personalized medicine will both increase patient outcomes and decrease side effects and unwanted complications. Prominent considerations of the role of pharmacists in health care management include the distribution of drugs and supplies, delivering drug-related information, and consultation to meet the needs of patients and health team members so their role is also very prominent in personalized medicine in the future.
“The Evolution of Pharmaceutical Biotechnology – Science, Strategies, Products, and Regulations”
Shows the latest developments in pharmaceutical biotechnology and provides a broad overview of biotherapeutic & biosimilar regulations globally and in the EU
Pharmacogenomics is the study of how an individual's genetic inheritance affects their response to drugs. It uses genomic tools in traditional pharmacology to enable predictive and personalized medication. The first observations of genetic variations affecting drug response date back to the 1950s. Approximately 106,000 deaths and 2.2 million serious adverse drug reactions occur each year due to the fact that "one size does not fit all" when it comes to medications. Pharmacogenomic technologies like genotyping and protein sequencing are used today to study how variations in genes like CYP450 and TPMT that encode drug-metabolizing enzymes can impact drug efficacy and safety.
ACRI is a leading clinical research training institute in Bangalore.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
hi.friends this is my first slide presentation which contain the information about the PERSONALIZED MEDICINES.this is the future medicinal treatment so,I hope you people like my presentation.
The document discusses in silico drug discovery methods including identifying potential drug targets, generating pharmacophore models, screening compound databases, and analyzing top hits through molecular docking simulations. A drug discovery strategy is outlined involving primary and secondary screening to identify lead compounds. The work plan describes using AutoDock Vina to dock and rank compounds, selecting the top 14 hits, and analyzing their binding interactions with HIV proteases. Nilotinib, lopinavir, ergoloid, and zafirlukast were evaluated in more detail and found to have high binding affinity to the target proteins.
This document presents an overview of personalized medicine. It defines personalized medicine as tailoring medical treatment to an individual patient's characteristics, needs and preferences. Personalized medicine is needed because similar symptoms can indicate different illnesses, and medical interventions do not always work for all people. Pharmacogenomics, the study of how genetic factors affect a person's response to drugs, is a key area of personalized medicine. Knowing a patient's genetic profile allows doctors to determine the best treatment and dosing for that individual. The advantages of personalized medicine include reducing disease burden, focusing on prevention, and lowering healthcare costs. Disadvantages include potential incorrect diagnostic results and genetic variations not being fully understood.
This document discusses the importance and benefits of pharmacogenetic testing for physicians and their patients. It notes that pharmacogenetic testing can help physicians determine the right drug, dose, and timing for each individual patient to reduce adverse drug reactions and improve outcomes. Not utilizing this testing could open physicians up to legal liability issues. The document provides several case studies demonstrating how pharmacogenetic testing could have helped identify the right treatment for patients and avoided negative health consequences or legal risks for physicians. It also addresses the ease of testing, billing, and reimbursement to make the case for integrating pharmacogenetics into medical practice.
This document discusses pharmacogenetics and how genetic differences can influence drug response. It introduces key concepts like the human genome project, pharmacogenomic effects on drug metabolism and transport, and how genetic testing can help determine who will respond to or be toxic to specific drugs. The goal is to develop personalized medicine where a person's genetic makeup is used to optimize drug selection and dosing for safety and effectiveness.
This document provides an overview of pharmacogenetics and discusses:
1. Pharmacogenetics is the study of how genetic factors influence individual responses to drugs. It considers both environmental and genetic factors that impact drug metabolism and effects.
2. Key concepts include how genetic polymorphisms affect drug metabolizing enzymes and transporters, leading to variability in drug efficacy and risk of adverse reactions between individuals.
3. The field has progressed from early discoveries of genetic disorders affecting drug response to now understanding the effects of common gene variants, with the goal of personalized medicine to optimize drug therapy for each patient.
Pharmacogenetics is the study of influences of a gene on therapeutic and adverse effects of drugs.
Pharmacogenetics plays an important role in drug development and drug safety.
Clinical application of cardiovascular pharmacogeneticsGowhar Shafi
This document discusses the clinical application of cardiovascular pharmacogenetics. It reviews major pharmacogenetic variants associated with commonly used cardiovascular medications such as antiplatelet agents, warfarin, statins, beta-blockers, diuretics, and antiarrhythmic drugs. Three principal classes of pharmacogenetic markers are discussed: 1) pharmacokinetic variants that influence drug metabolism and transport, 2) pharmacodynamic variants that influence drug targets, and 3) variants related to underlying disease mechanisms. For each drug class, specific genetic variants are described and their potential clinical implications are highlighted.
Olive Tree Consulting conducted market research and analysis to develop a marketing strategy for Margarita Dima's new vegetable company. They administered questionnaires to 537 people to understand Greek consumers' dietary habits, perceptions of bio vs conventional vegetables, and preferences regarding product attributes. Olive Tree also conducted focus groups and analyzed the Greek agricultural market. They identified the target audience as quality-focused consumers who shop at delicatessens and bio stores. Olive Tree developed recommendations for branding, positioning, pricing, distribution, and promotion to help Margarita Dima successfully launch her new vegetable company.
Executive Summary DM and PharmacogeneticsArmie Pacheco
This document discusses the role of pharmacogenetics in diabetes mellitus (DM) and its treatment. It provides background on DM, noting it is a leading cause of death and its complications include blindness, renal failure and cardiovascular disease. For type 2 DM (T2DM), current treatments aim to lower blood glucose but do not eliminate risk of complications. The document explores how genetic variants identified through genome-wide association studies can help elucidate biological mechanisms underlying T2DM and response to pharmacological interventions. It provides a review of pharmacogenetic investigations into specific anti-diabetes medications and how understanding these genetics can help develop individualized treatment strategies for optimal glucose control and reduced adverse events.
Genomic CDS: an example of a complex ontology for pharmacogenetics and clinic...Matthias Samwald
This document describes an ontology for representing pharmacogenomic knowledge and clinical decision support. The ontology models genetic variants, alleles, and patient profiles to enable clinical decision support. It represents alleles as combinations of necessary and sufficient variants. Patient profiles are described as combinations of variants, alleles, and copy number variations. The ontology enables checking patient profiles for consistency and inferring which clinical decision rules or dosing guidelines apply based on the profile. Reasoning over the ontology is challenging due to its complexity, and further optimization of reasoning tools is needed to handle real-world scenarios.
Medinfo2013 - An RDF/OWL Knowledge Base for Query Answering and Decision Supp...Matthias Samwald
This document describes an ontology-based knowledge base for clinical pharmacogenetics that represents genetic and pharmacogenetic knowledge to provide clinical decision support. It discusses how genetic variants and alleles are defined through logical axioms in the ontology. Treatment guidelines from drug labels are also represented. The knowledge base can describe individual patient genotypes and infer recommendations. It is being used to analyze decision support for virtual patient cohorts. The knowledge base uses OWL 2 DL and reasoning is performed with the TrOWL reasoner, which is more performant than other open reasoners for this ontology. Future work includes integrating standards and testing in clinical settings.
This document is the Fall 2015 issue of the Cameo, which is the newsletter of Zeta Phi Eta national professional fraternity. It provides information about the upcoming 52nd National Convention being held in New York City from October 2nd-4th, including the convention schedule and registration details. It introduces the current National Council officers and provides updates from the President, Foundation Executive Director, Vice President, Webmaster, Advisory Board Chair, and Central Office Executive Director on their roles and ongoing work with Zeta Phi Eta. The issue encourages members to attend the convention and get involved in the fraternity.
Pharmacogenetics is the study of how genetics affect individual responses to drugs. Variations in genes like CYP2D6, G6PD, and TPMT can determine drug metabolism and toxicity. Knowing a patient's genetic profile allows doctors to determine the right drug, dosage, and treatment schedule to maximize effectiveness and minimize adverse reactions. For a boy with leukemia, testing revealed a genetic variation that impacts thiopurine metabolism. His doctors were able to adjust his chemotherapy accordingly, preventing toxic side effects and allowing continued treatment. Pharmacogenetics aims to personalize drug therapy based on a patient's unique genetic makeup.
The Clinical Pharmacogenetics Implementation Consortium (CPIC) was formed in 2009 between PharmGKB and the Pharmacogenomics Research Network to address barriers to implementing pharmacogenetic tests in clinical practice. CPIC publishes peer-reviewed guidelines in a journal and on PharmGKB for using genetic information in drug therapy. Their guidelines provide gene-drug pairs and contact information for authors on published and underway guidelines to help with pharmacogenomic treatment.
La clínica maternal Happy Baby ofrece los mejores servicios para bebés, incluyendo quirófanos novedosos, salas de ultrasonido equipadas, salas de espera modernas y consultorios. Los precios de las consultas son de $100 pesos, ultrasonidos $80 pesos, y estudios $110 pesos, con transporte y ayuda económica gratuitos, así como pañales, biberones y ropa gratuitos.
The document summarizes a genome-wide association study of genetic variants associated with LDL-cholesterol lowering in response to rosuvastatin therapy. The study identified four loci reaching genome-wide significance for either absolute or fractional LDL-C reduction, including variants near PCSK9, ABCG2, LPA, and APOE genes. Carrying more risk alleles at these loci was associated with greater LDL-C lowering in response to rosuvastatin. The study provides insights into genetic factors influencing inter-individual variability in statin treatment response.
This document discusses pharmacogenetics and personalized medicine. It provides examples of genetic variations that can alter drug response, such as variations in receptors, enzymes, and metabolic pathways. Slow or deficient metabolism of drugs by enzymes like cytochromes and pseudocholinesterases can cause toxic drug accumulation. Genetic testing can help identify variations to optimize drug therapy for each individual and minimize adverse reactions. Personalized medicine uses pharmacogenetics to tailor treatments based on a person's genetic profile.
Pharmacogenetics of antipsychotic and antidepressentismail sadek
The document discusses the role of genetics and pharmacogenomics in personalized medicine and treatment of major depressive disorder. It outlines several genes and genetic variants that have been associated with variability in antidepressant drug response, including genes involved in drug metabolism (CYP2D6, CYP1A2, ABCB1), drug targets (SLC6A4, SLC6A3, HTR2A), and downstream signaling pathways (COMT, MAO-A, ADRB1, GNB3). Large clinical studies still need to determine how pharmacogenomic testing can improve clinical outcomes for depression.
Phenobarbital induces UGT1A1 enzyme.
Phenobarbital is known to induce various drug metabolizing enzymes including UGT1A1. By inducing UGT1A1, it increases the enzyme's activity and ability to conjugate and clear bilirubin, thus lowering bilirubin levels in patients with Crigler-Najjar syndrome type II who have some residual UGT1A1 activity.
The document discusses several key concepts in pharmacogenetics and genetics. It defines important terms like genotype, phenotype, gene, and allele. It describes different types of cell division and inheritance patterns like dominant, recessive, homozygous, and heterozygous. It also discusses variations in drug metabolism genes and their population frequencies. Gene therapy aims to replace defective genes with normal versions to correct phenotypic defects. Genetic contributions to disease include high-penetrance monogenic disorders caused by single gene mutations or chromosomal abnormalities.
Pharmacogenomics, Pharmacogenetics and Pharmacokinetics Zohaib HUSSAIN
Introduction
With the information available about human genome and human proteome, it is now well understood that there are a lot of variations between individuals. These minor variations account for many differences like adverse drug reactions, which are responsible for many hospitalizations and casualties. The observed variable effect of drug is due to difference in sensitivity as some people need higher dose and some need lower dose to get similar therapeutic effect, but in some people drug has no therapeutic effects and in some it shows strong adverse reactions.
La trigonometría estudia las relaciones entre los lados y ángulos de triángulos. Hiparco sentó las bases de la trigonometría al determinar la duración del año solar. Posteriormente, Napier inventó los logaritmos para facilitar cálculos trigonométricos y Euler encontró la relación entre propiedades trigonométricas y números complejos. La trigonometría es una herramienta básica para la navegación y para calcular la trayectoria de proyectiles.
This document provides an introduction to pharmacogenomics and personalized medicine. It discusses how genetic variations can impact individual drug responses in terms of efficacy and toxicity. These genetic differences, along with other factors like age, disease states, and environment, contribute to interindividual variability in drug responses. The emergence of pharmacogenomics through advances like the Human Genome Project aims to understand how a person's genetics can help determine the best treatment approach. This could help improve drug efficacy while decreasing adverse events and potentially saving time and resources through a more personalized treatment approach.
Pharmacogenomics- a step to personalized medicinesApusi Chowdhury
Pharmacogenomics aims to optimize drug therapy based on a patient's genotype to maximize efficacy and minimize adverse effects. It involves studying how genetic factors influence individual responses to drugs in terms of absorption, distribution, metabolism, and excretion. Genetic polymorphisms like SNPs that occur in over 1% of the population can impact a drug's effects. Pharmacogenomic testing identifies biomarkers related to drug metabolism and targets to determine effective treatments and dosages for patients. While it holds promise for improving drug development and personalized medicine, limitations include insufficient validation and high costs.
Pharmacogenomics is the study of how genetic factors affect individual responses to drugs. It aims to develop effective and safe medications tailored to a person's genetic profile. Variations in genes involved in drug metabolism and transport can impact drug efficacy and toxicity between individuals. Understanding these genetic differences may help optimize drug selection and dosing on a personalized level. While pharmacogenomics offers advantages like improved drug response and safety, challenges remain in fully validating results and identifying all relevant genetic variations due to drug pathways' complexity.
A biomarker strategy aims to answer key clinical questions to support drug development through identifying and testing biomarkers. Developing a robust biomarker strategy can mitigate risks and inform clinical study design by generating testable hypotheses to bridge pre-clinical and clinical research. Effective biomarker strategies consider assay suitability, study design, and sample availability to reliably detect biomarkers and provide statistically meaningful results. Emerging technologies allow deeper interrogation of drugs and disease through multiplexed readouts to enhance biomarker discovery and clinical development.
Humans are 99% similar to each other; but it is the 1% that is the cause of concern. This relatively small difference actually how a drug will effect our body. Pharmacogenomics is the study of how genes affect a person’s response to drugs. In order to prevent any unwanted reactions it has become necessary to consider one's genome while prescribing medicine. Thus pharmacogenomics is the starting point of personalized medicine.
Special topic genomics and personalized medicinewatsonma12
This document discusses the emerging field of personalized medicine and how genomics is enabling more targeted medical treatments. It provides examples of how genetic testing can identify patients who will benefit from certain drugs, like Herceptin for breast cancer patients with high levels of the HER-2 gene. The document also outlines some technical, social, and ethical challenges to widespread adoption of personalized medicine, such as improving genetic testing technologies, educating physicians, and preventing discrimination based on genetic information.
Pharmacogenomics aims to optimize drug therapy based on a patient's genotype. Genetic factors can account for 20-95% of variability in drug response. Polymorphisms like SNPs that occur in over 1% of a population can impact drug metabolism and effects. Pharmacogenomic testing targets biomarkers for specific drug classes to determine efficacy and avoid toxicity. While it has potential to improve prescribing, limitations include many genes influencing drugs and ethical issues. Personalized medicine based on pharmacogenomics is still developing.
INTRODUCTION
What is pharmacogenomics
History
Principle
So what’s new about pharmacogenomics?
single nucleotide polymorphism (SNP)?
Genes commonly involved in pharmacogenomic drug metabolism and response
The anticipated benefits of pharmacogenomics
Pharmacogenetics Research/Database Program
Some of the barriers to using pharmacogenomics
Conclusion
References
Pharmacogenomics examines genetic variations that influence individual drug responses. Single nucleotide polymorphisms (SNPs) can predict good, bad, or no response to a drug. DNA microarrays efficiently identify SNPs to personalize treatment. This allows excluding non-responsive patients from trials, improving drug safety and efficacy. Currently, pharmacogenomics guides cancer treatment and medications metabolized by cytochrome P450 enzymes to prevent overdosing. Benefits include tailored therapy and safer drugs, though complexity challenges wide implementation.
This document discusses personalized medicine, which aims to provide the right treatment for each individual patient based on their genetic profile. It defines personalized medicine as tailoring medical treatment to each patient's characteristics, needs and preferences. The development of genomic sequencing allows for more precise treatment by understanding how genetic variations impact drug metabolism and response. Pharmacogenomics studies how DNA and RNA variations affect drug effectiveness. Implementing personalized medicine through genetic testing can help reduce disease burden by improving prevention, treatment and healthcare costs while minimizing risks.
2015 04-13 Pharma Nutrition 2015 Philadelphia Alain van GoolAlain van Gool
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Pharmacogenomics is the study of how an individual's genetic profile affects their response to medications. It aims to provide the right drug at the right dose for the right patient by understanding genetic factors. Current applications include testing for genetic variants before prescribing certain drugs to avoid bad reactions. Challenges include accounting for both genetic and environmental influences on drug responses and protecting patient privacy. As understanding and technologies improve, pharmacogenomics may help develop new drugs and reduce trial-and-error prescribing.
President Obama launched the Precision Medicine Initiative in 2015 to advance personalized healthcare by tailoring treatment to individual patient characteristics. Pharmacogenomics studies how genetic variations affect drug responses and can be used to predict efficacy and adverse reactions. While personalized medicine offers benefits like improved outcomes and safety, limitations include lack of reimbursement and need for more clinician education. Examples of FDA-approved drugs incorporating genetic markers are warfarin, which labels variants affecting dosing, and cancer drugs like Herceptin that target specific genetic mutations.
- Pharmacogenomics deals with how genetic variations influence individual responses to drugs in terms of efficacy and toxicity. It aims to identify individuals who are more or less likely to respond to drugs or require altered doses.
- Pharmacogenetics studies variations in targeted genes or related genes, while pharmacogenomics uses genetic information to guide individualized drug and dose choice.
- Genetic polymorphisms like SNPs can result in different amino acids, protein changes, or no effect. They influence drug metabolism and response.
- Pharmacogenomics offers advantages like personalized medicine but faces barriers like complexity, education needs, and drug company incentives. It is being applied in various stages of clinical trials from target identification to dosing.
Pharmacogenomics refers to the study of the relationship between specific DNA-sequence variation and drug effect, for example, variation in haplotype versus variation in therapeutic outcome
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2. Preface
• Definitions
• Factors Affecting Genomic Analysis
• ‘Pharmacogenetics in clinical medicine’
• The Complexities
• “Credibility” of pharmacogenetics!
• Disadvantages
• Pharmacogenomics Testing!
• Issues
3. Definitions
• Pharmacogenetics
is the study of genetic variation that affects response
to medicines.
• Pharmacogenomics
use of genome based techniques in drug
development
• Personalized Medicines
treatment, based upon the individual-specific factors
underlying disease and drug response
(Vijverberg et al., 2010)
4. Factors of Pharmacogenesis
• Pharmacogenetic factors operate at
pharmacokinetic (PK) levels
pharmacodynamic(PD) levels
(Shah RR., 2005)
• The role of genetic factors when investigating a drug
for its pharmacokinetics, pharmacodynamics, dose–
response relationship and drug interaction potential.
(Vijverberg et al., 2010)
5. Clinical significance of pharmacogenetic
variability in pharmacokinetics
• Metabolizing drugs needs more than a single enzyme.
• Expression of drug metabolizing enzymes with altered
specificity/functional activity.
• Even the serious ADRs are not related to a specific
genotype (Clark et al., 2004).
• P-glycoprotein and associated organic ion transporters
also affect the disposition of many drugs.
• PK is not an essential basis of all toxic effects.
(Shah RR., 2005)
6. Factors Affecting Genomic Analysis
(Ding et al., 2010)
Copy
Number
variation
Pathway Mutation
Analysis Spectrum
Methylation
7. Disadvantages of Pharmacogenetic
Studies Design
• Insufficient knowledge about potential variability
• Overestimation of the results and efficacy of drug
• More erosion of short-term and long-term safety data
• Distorted comparisons in active controlled trials
• Arbitrary exclusion conditions
• Neglect of the presence of multiple variant alleles at a
given locus
• No investigation of safety and efficacy in the genotypes
excluded
• Design overlooks the importance of PD polymorphisms
(Shah RR., 2005)
8. Pharmacogenetics in clinical
medicine
• Inconsistence and contradiction of
pharmacogenetic studies of specific drug-
induced toxic effects.
– Discrepancy in Thiorizadine and CYP2D6 status.
– Contradiction in the studies of neuroleptics and
antidepressants with CYP2D6.
– No evidence of impaired metabolism of oral
diclofenac in heterozygous and homozygous
carriers of the CYP2C9 alleles (Kirchheiner et al.
2003c).
9. Complexity in Pharmacogenetics
– Pharmacokinetic levels
– pharmacodynamic levels
– Phenotype
– Heterozygous & Homozygous States
– Multiple alleles at a single locus
– nucleotide polymorphism(s)
– Not all relevant pharmacogenetic variations will be
SNPs (Idle et al. 2000).
– Interaction between Genotype and Extrinsic factors.
– Drug-Drug Interaction
for example terfenadine, mibefradil, cerivastatin, cisapride and
levacetylmethadol.
(Shah RR., 2005)
10. Figure1: Analysis of 164 “Expression Intersection”
genes/proteins in breast tumors (Pujana et al., 2007).
11. Figure2: The Map of global network containing 234 liver cancer-associated
genes, 1056 nodes and 3425 edges of liver cancer
(Wang Z. & Wang YY., 2013).
12. Pharmacogenomics Testing
• Lack of genotypic data.
• Additional costs for genetic testing
• Lack of large-scale prospective clinical
evaluations for impact of genetic variability in
drug disposition and response.
• Relative Resistance to use genetic testing to
individualize drug therapies.
(Xie & Frueh, 2005)
13. Credibility of pharmacogenetics!
Impossibility to achieve distinct genotype in phenotype-genotype association
studies of human populations.
Examples:
• Reviewing 12 hospital that linked thiopurine-related drug toxicity to
thiopurine methyltransferase TPMT genotype, found more than 78% of
adverse drug reactions were associated with different factors other than
TPMT-gene polymorphism.
• CYP2D6 monooxygenase metabolises 25-30% of drugs. CYP2D6 gene 75
variant alleles detected. All to be tested before speculation.
• Genetic and epigenetic background of a patient is changing via environmental
changes in a decade. Patient’s genome, diet, intestinal flora, changes in
lifestyle and exposure to drug and chemicals should be analysed
simultaneously.
(Nebert and Vesell, 2006)
14. Consent
• Clear description of the participant’s role.
• Description of all members and firms involved in the
research.
• Protection of confidentiality.
• How the participant’s DNA will be defined and
shared with other investigators.
• Will the participant share benefits if the research
contributed to development of a product?
• What if the participant’s DNA study revealed
sensitive information which might have unpleasant
consequences.
(Nebert & Bingham, 2001)
15. Consent
The following is a section from consent form in genetic
research:
“Discoveries made with your DNA samples may be patented by us and the
University. These patents may be sold or licensed, which could give a company
the sole right to make and sell products or offer testing based on the discovery.
Royalties may be paid to us, the University, and the Sponsor. It is not our intent to
share any of these possible royalties with you.”
Commercialization of patient gene.
• Example on Canavan’s gene dispute.
(Marshall, 2000)
16. Health Insurance
• Insurers might classify clients according to their
genotypes.
• If genotype indicates poor response to a drug (or
group of drugs), the client might be denied the cover,
even if he/she is completely healthy.
• Health insurers could set high premium relying on
only drug history of clients, as that might indicate
their genotype
18. Social Issues
• Pharmacogenomics may be used to promote
ethnic/racial stereotypes.
• Pharmacogenomics may broaden the
healthcare gap between the rich and poor
• Insurance discrimination
• Employment discrimination
21. Privacy Issues
Confidentiality and Privacy
Use of pharmacogenomic information
Pharmacogenomic information can be inferred
from relatives.
• A case when a father blocked his son from participating
in a genetic research via OHRP after learning that,
family history was invaded without consent.
Authority abuse
22. Religious Issues
Genetic screening will change the way humans reproduce.
1. People will use it to select for a “Better child”.
Messing with god’s creation and nature.
2. Abortion becomes an issue.
– some religions consider any interference with the natural act
of reproduction to be immoral.
Like: In the Roman Catholic view, any act of reproduction that is not
performed by the natural way is immoral (Smith, 1989).
3. Individuals who were carriers for genetic abnormalities..
Would they be encouraged not to reproduce?
23. Educational Issues
“Pharmacists”
• Pharmacists are responsible to provide medication counseling
and drug information to patients.
• Assessment of the knowledge, attitudes and education of
over 700 pharmacists.
Total doctors registered on
LRMP 252,469
63.2% from the UK (GMC,
2012)
More than 50,000
registered pharmacists
(GPhC, 2010)
(Roederer et al., 2012)
24. Psychological Problems
• In case of depression pharmacogenomic info
can be damaging.
• May lead to feeling of helplessness.
• Some patients may become sad, angry or
anxious if they learn that they have a
mutation in a cancer susceptibility gene.
• If these feelings are very intense,
psychological counseling will be a necessity.
25. Financial/Economic Issues
Commercial Goal Dominates the Scientific Goal.
• OpGen Closes $17M to Market Microbial Whole-Genome Analysis Platform
( Gene Engineering and Biotechnology News, 2010)
• Economic :Royal claimed, which are not being widely discussed, namely that
NitroMed Inc., BiDil’s manufacturer, has a monopoly on this patent, which
was due to expire in 2007 but has now been extended to 2020 as a result of
the drugmaker re-marketing BiDil for use among African Americans.
• Cost: BiDil sells for $1.80 per pill, far more than generic drugs at 30 cents a
pill So or $10.80 per day, based on the target dose of six pills per day.
• Very expensive . What about Failures Cost?
26. Ethical Issues
Ethical Principles in Human Genetics and
Genomics according to Chadwick and Knoppers :
• Reciprocity
• Mutuality (Family)
• Solidarity
• Citizenry
• Universality
(Vijverberg et al., 2010)
27. Bonnie Green (PhD Sociology/Genomics)
ESRC Centre for Genomics in Society/University of Exeter(Posted 2 years ago).
28. Rising Questions
• Would you undergo the ‘Genetic Test’? Why?
• Are statistics of genetic studies sufficiently credible?
• Does gene analysis stand solely in treatment sector?
• Is it ethical to discriminate people in Insurance and work
companies relying on their Genetic Profiling?
• Do you Accept promotion of “Race Marketing”?
• Would you like to hear ‘Future Bizzard’ about you which
may never happen?
29. References
• Clark, D. W., Donnelly, E., Coulter, D. M., Roberts, R. L. & Kennedy, M. A.
(2004). Linking pharmacovigilance with pharmacogenetics. Drug Safety; 27:
1171–1184.
• CLeod H. (2012). DisclosuresPersonalized Medicine; 9(1):19-27.
• Ding L., Wendl C.M., Koboldt C.D., Mardis R.E. . (2010). Analysis of next-
generation genomic data in cancer: accomplishments and challenges. Human
Molecular Genetics . 19 (R2)
• Huang M-S., Temple R.. (2008). Is This the Drug or Dose for You?: Impact and
Consideration of Ethnic Factors in Global Drug Development, Regulatory
Review, and Clinical Practice. CliniCal pharmaCology & TherapeuTiCs, nature
publishing group; 84 (3):287-294.
• Idle, J. R., Corchero, J. & Gonzalez, F. J. (2000). Medical implications of HGP’s
sequence of chromosome 22.Lancet ; 355, 319.
• Kirchheiner, J., Meineke, I., Steinbach, N., Meisel, C., Roots, I. & Brockmoller,
J. (2003c). Pharmacokinetics of diclofenac and inhibition of cyclooxygenases 1
and 2. No relationship to the CYP2C9 genetic polymorphism in humans. Br. J.
Clin. Pharmacol. 55:51–61.
• Littlejohns P. (2006). Trastuzumab for early breast cancer: evolution or
revolution? The lancet; 7:22-23.
30. References
• Meissner D. (2007). Report of an International Group of Experts. Ethical, Legal
and Social Implications of Pharmacogenomics in Developing Countries.
Switzerland: World Health Organization. p2-67.
• Merz JF., Magnus D., Cho MK. and Caplan AL. (2002). Protecting Subjects’
Interests in Genetics Research. Am. J. Hum. Genet. 70:965–97.
• Mordini E. (2004). Ethical considerations on pharmacogenomics.
Pharmacological Research; 49:375-379.
• Nebert D. W. and Bingham E. (2001). Pharmacogenomics: out of the lab and
into the Community. TRENDS in Biotechnology; 19:519-523.
• Nebert D. W. and Vesell E. S. (2006). Can personalized drug therapy be
achieved? A closer look at pharmaco-metabonomics. TRENDS in
Biotechnology; 27:580-586.
• Nebert DW., Jorge-Nebert L., Vesell ES. (2003). Pharmacogenomics and
"individualized drug therapy": high expectations and disappointing
achievements, J. Pharmacogenomics; 3(6):361-70.
• Özdemir V.,Fisher E., Dove E. S., Burton H., Wright G. E. B., Masellis M., and
Warnich L. (2012). End of the Beginning and Public Health
Pharmacogenomics: Knowledge in ‘Mode 2’ and P5 Medicine, Current
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31. References
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Editor's Notes
Herceptin survival rate plus chemotherapy: 79 % and the chemotherapy :68% so difference improvement is only 11% .Herceptin described only for phase 4 only.
In the context of polymorphic drug metabolizing enzymes, some limitations in applying pharmacogenetics to therapeutics are already self evident. These are:Very few drugs are metabolized by a single enzyme. Furthermore, PMs are often able to utilize alternative, but often less effective, pathways of elimination.Many drug metabolizing enzymes are subject to variant alleles which express enzymes with altered substrate specificity or altered functional activity.Not all ADRs of a drug are genetically determined even if a drug is metabolized by a single pathway. Whereas only one or two of these may have genetic basis. Small systematic studies suggest that often, not even the serious ADRs are associated with a specific genotype.In addition to drug metabolizing enzymes, P-glycoprotein(These are part of a larger family of efflux transporters.) and associated organic ion transporters also influence the disposition of many drugs. These play an important role in the absorption of drugs and their transport into the cells and elimination into the bile or urine. Not all toxic effects need have a pharmacokinetic basis.
insufficient information regarding potential variability in the target populationThe field of pharmacogenomics is fairly dynamic, and laboratory data are generated at a very high speed. What might be the ‘best’ pharmacogenomics test for a certain condition today, might not be six months later.arbitrary exclusion criteria since multiple enzymes frequently involved in drug metabolism and subjective exclusion and inclusion of the groups or persons.disregard for the presence of multiple variant alleles at a given locus, which may have different substrate specificity—which genotypes are candidates for exclusion?not possible to investigate safety and efficacy of even the lower doses in genotypes excluded so the results will be missing the exclusion part.as proposed and currently applied, this design overlooks the importance of pharmacodynamic polymorphisms and of haplotypes
Available data illustrate an important point from the regulatory perspective. Promises of potential clinical benefits from integrating pharmacogenetics in clinical medicine are often based on inappropriate presumptions on the role of polymorphic drug metabolizing enzymes or pharmacological targets. As discussed below, a number of drugs illustrate this point and often, the results from pharmacogenetic studies of specific drug-induced toxic effects are inconsistent or contradictory.Thioridazine has been shown in healthy volunteers to have a dose related effect on ventricular repolarization,primarily due to the parent drug with a possible contribution from the metabolites (Hartigan-Go et al.1996). One recent study reported that CYP2D6 status might be an important determinant of the risk for thioridazine-induced QTc interval prolongation Llerena et al. 2002) while another reported that CYP2D6 genotype does not substantially affect the risk of thioridazine-induced QTc interval prolongation(Thanaccody et al. 2003). This discrepancy is present in this research and many others. To further add, Two classes of drugs, antidepressants and neuroleptics,have narrow therapeutic index and are generally metabolized predominantly by CYP2D6. Althoughsmall retrospective studies appear to show a correlation between genotype and toxicity or failure to respond (Rau et al. 2004), overall analyses of studies correlating CYP2D6 genotype with response to these drugs(referred to as phenotype) have been cautious in their Conclusions. These disappointing findings are hardly surprising since a number of these drugs are also metabolized by pathways other than those mediated by CYP2D6 and frequently, these drugs have metabolites that are pharmacologically active in terms of efficacy and ADRs.A more recent study has also found no evidence of impaired metabolism of oral diclofenac in heterozygous and homozygous carriers of the CYP2C9 alleles *2 and *3 compared with the wild type allele and marked diclofenac-mediated inhibition of COX-1 and COX-2 activity was detected in all individuals independent of CYP2C9 genotype(Kirchheiner et al. 2003c).
pharmacogenetic approaches during drug development will have to be more ‘holistic’. These approaches will have to focus on investigating genetic influences not only at pharmacokinetic (drug metabolizing enzymes and transporters) but also at pharmacodynamic (pharmacological targets) levels to fully characterize the pharmacology of drugs. Clearly, a patient’s overall genotype that determines a drug response (phenotype) must take into account the presence of normal wild type and mutant alleles in heterozygous and homozygous states at both these key components of the dose–response relationship. The situation becomes even more complex when one also considers the presence of multiple alleles at a single locus. it may be too optimistic to believe that all relevant pharmacogenetic variations will be SNPs,especially as we already know examples of large deletions, amplifications and re-arrangements (Idle et al. 2000).An important factor that is likely to limit the potentially beneficial application of pharmacogenetics is the interaction between the genotype and extrinsic factors ( menstrual cycle, stress,... Drug–drug interactions are another major problem and have frequently resulted in withdrawal of drugs from the market, for example terfenadine, mibefradil, cerivastatin, cisapride and levacetylmethadol. The inhibition of drug metabolizing enzymes by other drugs is an important point of intersection between pharmacogenetics and drug response.In the meantime, prescribing should comply with the information provided while pharmacogenetic research is deservedly supported by all concerned but without unrealistic expectations. education of the prescribing community should also be considered.
Expression analysis of the XPRSS-Int data set in breast tumors. Top right, comparison of gene expression in BRCA1mut breast tumors relative to sporadic breast tumors both for genes in the XPRSS-Int set (vertical lines) and for 100 randomly generated equivalent sets of genes (curves; see Methods).Left, network representation of genes in the XPRSS-Int set that show expression changes in BRCA1mut breast tumors relative to sporadic breast tumors. Edge distances to the four reference genes are optimized to be inversely proportional to their average PCCs across normal tissues (in other words, shorter edges indicate higher coexpression values).To identify potential functional associations involving all four reference genes, we focused on those transcripts found in the ‘expressionintersection’ (XPRSS-Int) of the four coexpression sets.
It is known that for several types of cancers, an effective therapy requires the simultaneous inhibition of multiple oncogenic kinases [1] or the targeting of many different pathways .The Map of total modules of liver cancer. The interaction network of modules extracted from the global network containing 234 liver cancer-associated genes, 1056 nodes and 3425 edges [downloaded from the OMIM database on July 6, 2012 and analyzed by the Agilent Literature Search plugin (version 2.77) in Cytoscape (version 2.8.2)]. The module interaction network is constructed using 166 modules identified by Markov clustering (MCL, Inflation = 2) (average size: 6.331, maximum size: 59, minimum size: 2, modularity: 0.534). The green nodes, blue square and gray edges denote the liver cancer-associated genes we entered, a module and the inter-module connections, respectively.
1.Major limitation is the lack of genotyping data. There is limited evidence to justify prospective pharmacogenomic testing. Furthermore, the infrastructure for genotyping is only available in a subset of centres.3.To determine whether or how to use pharmacogenetic test to predict ability of an individual patient to metabolize,transport,and respond to a given drug will require reliable prospective genotype to phenotype evaluation.4.Bcoz conventianol trial-and-error and one size-fits-all approaches to prescribe medicines hv long been widely accepted by most practising physicians who graduated b4 the era of human genome.
Practically, due to complexity & polymorphism of genome, it is impossible to achieving distinct genotype in phenotype-genotype association studies of human populations. Examples:CYP genes encodes enzymes responsible for metabolism of almost all drugs. CYP2D6 monooxygenase, metabolises 25-33% of drugs. It is difficult to know how the patient would react to a drug knowing that there are 75 variant alleles of CYP2D6 gene, and all should be tested before speculate drug metabolism pattern of patientThe human genome contains 57, putatively functional, CYP genes that encode phase I enzymes involved in oxidative and reductive reactions……..Therefore, unless every variant site in the genome that affects CYP2D6 expression is tested, it is difficult to conclude that a patient is a poor, intermediate, efficient, or ultra-rapid metabolizer
There are some issues regarding patient’s informed consent needed to be considered.
In year 2000, researchers in Canavan’sgene were taken to court by 3 families and 2 Canavandisease associations, who provided participants to the research to block gene patent which used in commercial test.
The extensiveacquisition of genetic information that a wide-ranging programme of pharmacogeneticswould involve might also lead to violations of legitimate expectations of confidentiality andprivacy, and unfair discrimination.
There has been a lot of concern about whether the approval of ethnic drugs would promote the re-biologisation of race within medical research and practice. However, BiDil® does show that subgroup-directed treatment of ethnic minority groups can also have a positive discriminative effect.Race and ethnicity are not the key to unlocking the secrets of the causes of disease, but are constantly evolving conceptual tools for assessing needs and inequality and for guiding health policy and practical actions. As such, racial and ethnic differences and similarities in the susceptibility of specific diseases might even provide the basis for reinventing community-based public health.Nevertheless, a clinical study designed to investigate the efficacy of BiDil® in people of different races never took place. There is still a debate going on about whether genetic variance may explain the drug efficacy in African Americans, and whether BiDil® can be considered a pharmacogenomics application.The working mechanism of the drug remains to be clarified.
Unlike medical history, pharmacogenomic information is very easy to obtain.In research, ethical thinking evolves due to the fast pace of research. Genome-wide association studies trying to identify genes thatcontribute a small risk to common diseases can only be performed on an international scale. Meanwhile, it is becoming more and moreclear that genomic information is hard to hide. Thus the traditional promise in research that privacy will be protected appears to be lessrealistic. Nowadays, adequate information (veracity) and protection against potential risks of discrimination based on predictive medicalinformation is required. A new balance needs to be found.The person who is going through genetic testing may learn info about themselves and family members.(Nash)They may also know about adoption.(Nash)And this causes strained relationships among relatives
Total doctors registered on LRMP 252,469 63.2% from the UK (GMC, 2012)More than 50,000 registered pharmacists (GPhC, 2010)LRMP : list of registered medical practitioners.Not only british also international doctors who need to be educated too .GMC : general medical councilGPhC: general pharmaceutical councilEvery year should the pharmacists be registred.
FDA approval, BiDil’s projected market opportunity nearly tripled to $3 billion as NitroMed announced BiDil pricing at $1.80 per pill, or $10.80 per day, based on the target dose of six pills per day.
In recent debates,Chadwick and Knoppers have proposed a new framework of ethicalprinciples to address research in human genetics and genomics :Reciprocity (exchange information between researchers and participants; transparency, also concerning possible commercialisation)• Mutuality (genetic information and DNA as family property –risk-sharing within families)• Solidarity (a willingness to share information for the benefit of others; common interests or interest in common)• Citizenry (public involvement with science [policy]; genetic heritage and collective identity)• Universality. (the human genome as a shared resource; common heritage of humanity; obligations to future generationsand benefit sharing)
BiDil : Charmaine Royal, Ph. D., director of the GenEthics Unit at the National Human Genome Center, says African Americans should not be treated as a monolith when it comes to drug therapy.
Are there other Non-Genetic factors involved?What about Children?