CPIC Guidelines
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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.
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Pharmacogenomics, Pharmacogenetics and Pharmacokinetics
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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.
Ecuaciones con mas de una funcion trigonometrica
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.
Pharmacogenetics & Teratogenicity
Pharmacogenomics is the study of how genetic variations impact individual responses to drugs. Genetic variations can influence drug metabolism and effects, leading to decreased effectiveness or increased toxicity. Understanding pharmacogenomics allows for personalized drug selection and dosing based on a person's genetics. Teratogenicity refers to birth defects caused when foreign substances cross the placenta during pregnancy. The period of organ formation is most vulnerable. Counseling women on known teratogens and untreated conditions helps weigh risks and select safest treatment options.
Pharmacogenetics devang
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.
Snp
This document discusses single nucleotide polymorphisms (SNPs). It defines SNPs as single base changes in DNA sequences that occur in at least 1% of a large population. The document notes that while human genomes are 99.9% identical, there are positions where some people have one nucleotide pair while others have another, which are called SNPs. SNPs are described as the most common form of genetic variation, with over 90% of human genetic variations coming from SNPs. The uses and implications of SNPs are also summarized.
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Pharmacogenomics Dissemination of Information
This document provides an overview of pharmacogenomics and how genetic testing can help determine safe and effective medication selection, using the antidepressant venlafaxine as an example. The summary discusses how certain genetic polymorphisms affecting the CYP2D6 enzyme can impact an individual's response to venlafaxine, potentially leading to side effects or increased risk of suicide. Five studies cited found this relationship between CYP2D6 polymorphism and adverse reactions to venlafaxine. The implications are that genetic testing may help identify patients for whom venlafaxine poses higher risks due to their specific genetic profile.
ICH [ Q ] Guidelines
OBJECTIVES
AIM
ICH ORGANISATION STRUCTURE
ICH MEMBERS
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ICH GUIDELINES CATEGORIES
[Q] QUALITY GUIDELINES
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Pharmaogenomics
Pharmacogenomics is the study of how genes affect individual responses to drugs. It combines pharmacology and genomics to develop safe and effective personalized medications and dosages based on a person's genetic makeup. The goal is to improve treatment outcomes by predicting drug effectiveness and reducing adverse reactions. Challenges include implementing genetic tests in clinical practice and addressing cost, ethical and legal issues. Future applications include developing tailored drugs for many diseases and faster, more targeted clinical trials through biomarkers.
Ich
The document discusses the International Council for Harmonization (ICH). ICH aims to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan, and the United States to reduce duplication of testing and make the development of new medicines more efficient. It outlines the structure of ICH, including its steering committee and expert working groups. ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics. The overall goal is to streamline drug development while maintaining high standards for safety, quality and efficacy.
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This document discusses computational modeling techniques for predicting drug disposition properties. It covers modeling approaches for drug absorption, distribution, and excretion. For absorption, it describes models for predicting solubility, intestinal permeability, and transporters. For distribution, it discusses models for volume of distribution, plasma protein binding, and blood-brain barrier permeability. For excretion, it summarizes models for hepatic and renal clearance. Current challenges include incorporating active transporters and generating predictive models from physiological understanding rather than empirical correlations.
GOOD PHARMACOVIGILANCE PRACTICES
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
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NEW DRUG APPLICATION (NDA)
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
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Pharmacist Sherif Mohamed El-Refai supports several charities, including the Livestrong Foundation, which supports those battling cancer or who have recently survived cancer. Through donations and other forms of support from people like Sherif Mohamed El-Refai, Livestrong hosts a variety of programs, provides cancer research grants, and participates in advocacy with government organizations.
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- 1. Sherif El Refai CPIC GUIDELINES FOR PHARMACOGENOMIC THERAPY
- 2. “The Clinical Pharmacogenetics Implementation Consortium (CPIC) was formed in late 2009, as a shared project between PharmGKB and the Pharmacogenomics Research Network. CPIC guidelines are peer-reviewed and published in a leading journal (in partnership with Clinical Pharmacology and Therapeutics) with simultaneous posting to PharmGKB with supplemental information/data and updates. Anyone with clinical interests in pharmacogenetics is eligible for membership. CPIC's goal is to address some of the barriers to implementation of pharmacogenetic tests into clinical practice” – PharmGKB WHAT IS CPIC
- 3. Gene Drug Pairs Status Author Contact TPMT - thiopurines published (online Jan 2011) Mary Relling CYP2C19 - clopidogrel published (online Jun 2011); endorsed by The American Society of Health-System Pharmacists (ASHP) Alan Shuldiner CYP2C9, VKORC1 - warfarin published (online Sep 2011) Julie Johnson CYP2D6 - codeine published (online Dec 2011) Kris Crews HLA-B - abacavir published (online Feb 2012) Deanna Kroetz SLCO1B1 - simvastatin published (online May 2012) Laura Ramsey HLA-B - allopurinol published (online Oct 2012) Ming-Ta Michael Lee CYP2D6, CYP2C19 - TCAs published (online March 2013) Kevin Hicks HLA-B - carbamazepine published (online May 2013) Susan Leckband DPYD - 5FU / capecitabine published (online Sept 2013) Kelly E. Caudle IL28B - pegIntron published (online Oct 2013) Andrew Muir HLA-B - phenytoin underway Tom Callaghan G6PD - rasburicase, Septra submitted Ellen McDonagh, Tamara Chang CYP2D6 - SSRIs underway Andrea Gaedigk CFTR - Ivacaftor published (online March 2014) Kathleen M Giacomini CYP3A - tacrolimus underway Ken Thummel UGT1A1 - irinotecan WHICH CPIC GUIDELINES ARE AVAILABLE? CPIC Drug-Gene Guidelines
- 4. Sherif El Refai is currently researching pharmacogenomics & individualized therapy at the UNC Eshelman School of Pharmacy. UNC CPIT CONCLUSION