For patients suffering from disease, the impact of new medications is often improved quality of life. Reasons for Innovation Deficit Increased drug safety demands by FDA the average number of clinical trials per new drug application (NDA) increased from 30 in the 70s to 40 in the 80s, to 70 in the 90s Lead to the prolonged duration of the drug development process. ----- is what the body does to the drug and -----is what the drug … kellee93. To undergo preliminary testing in healthy humans to monitor the effects of the drug. Group: Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. Drug developers and sponsors. Search. all of the above (small organic molecule interacts with biological target triggering, large biologic molecule, exogenous chemical or biologic) What is the primary objective of drug discovery. Who makes the active components of medicines? This is an example of alternative career goals if one wishes to apply knowledge of the drug discovery and development process to regulatory affairs. Find Test Answers Search for test and quiz questions and answers. The disease/condition the product is targeting, Novelty of the active ingredient and time to market, Novelty of the active ingredient and clinical improvement, Clinical improvement and effectiveness of product, Future development may prove effective for treating another condition, Rewriting the package insert to eliminate a black box warning, Phase 4 trials are typically not randomized/placebo controlled, Phase 4 trials are typically when the product is finalized and submitted for patent protection, Phase 4 trials may include new populations in which to test the drug, Phase 4 trials may include new formulations and/or adjusted dosing regimens. What is the approximate ratio of potential compounds the beginning of Development to number of products that ultimately get FDA approval? from the back of a tree, but they have to refined and tested in clinical trials. Spell. based test administration in which each candidate takes a unique, customised examination. Pharmacology is the study of a drug's pharmacological effect (Drug Action) on the body. You can usually tell if a drug is a natural product because: Paclitaxel, the potent anticancer drug, was isolated from which natural source? This is a science in itself- … What is considered the foundation of the product's marketing strategy? Pharmacology is the study of a drug's pharmacological effect (Drug Action) on the body. This essay provides the description of the basic concepts of drug discovery and development, and identifies the role of some medicinal chemistry, such as pharmacology and pharmacokinetics. Which phase in clinical development is the largest investment of both time and money? Write. Trivia Questions Quiz, Drug And Poison Antidotes (Exam Mode)- Rnpedia. What is 'simplification' when referred to in drug development terms? Academia.edu is a platform for academics to share research papers. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. Operations, you got off easy last time, please this time describe something new you learned and, if possible, how … The development of drugs is a long, complicated and expensive process. Our aim is to help scientists whose research may be relevant to drug discovery and/or development to frame their research report in a way that appropriately places their findings within the drug discovery and development process and thereby support effective translation of preclinical … Drug Design and development MCQ's Quizlet bank 1: The strongest hydrogen bond acceptor… a) amine nitrogen b) aniline nitrogen c) carboxylate oxygen d) amide nitrogen 2: Different protein subunits in… State One Stage Of Drug Discovery And Development (i.e. The definition for a lead compound is - a novel compound discovered to have pharmaceutical potential which is a good starting point for drug development. Which department is not primarily involved with the creation of the package insert? Which statement about the process of drug discovery is true? This is an example of alternative career goals if one wishes to apply knowledge of the drug discovery and development process to regulatory affairs. Start studying Drug Discovery and Development EXAM 1. What is the term for the process that is used to prove that a drug is safe and effective in treating specific conditions in certain patient populations? Removing question excerpt is a premium feature. Large-scale tests in people with the target disease/population, Managing risks and complying with FDA requirements, Improving time to market and decreasing toxicity, Accelerating time to market and managing risk, Complying with FDA requirements and improving efficacy, Identifying the target population for the lead compound that is being developed, Aligning the development process with the strategic aims of the company, To select a lead compound from a lead series, To establish the safety of administration to humans, To test whether the proposed drug actually works, Small-scale trials on 100-150 patients with a target disease, Demonstrating safety and efficacy during phase 2 clinical trials. To do this, they create and study new drugs. 16:137:510 Drug Development from Concept to Market (Fall, 3) This course provides an overview of the pharmaceutical industry, ranging from early drug discovery to bringing new small molecule and biological pharmaceutical products to the market. a) It only encompasses the non-clinical laboratory and animal testing. A drug goes from being an idea in the lab to something that a doctor prescribes. Drug Discovery in the Pharmacology at Yale University has a rich history of achievement and a strong tradition of scholarship. Sample exam questions - health, disease and medicine development Understanding how to approach exam questions helps to boost exam performance. Microbiology Interview Questions; Question 13. THE PROCESS TAKES APPROXIMATELY 3-6 YEARS. FDA Review. To create a basic outline for the larger scale future tests on a widespread population. Although not required 2, each registered participant to expected to take the online final exam, which consists of 25-50 multiple choice questions. Assays are test systems that evaluate the effects of the new drug candidate at the cellular, molecular, and biochemical levels. With the rapid pace of scientific advances, there is increased understanding of disease states resulting in research and development of new drugs to treat disease. Question 1 Which statement about the process of drug discovery is true? In spite of the lack of new AD medicines in recent years, the drug discovery and development process has improved as a result of more precise diagnosis, information on natural history of AD and measurement of clinical progression, better biomarkers, genetic findings, and knowledge of pathophysiology. By the mid-20th century, therapeutically useful alka-loids had been purifi ed and derivatized from the ergot fungus, as uterotonic and sympatholytic agents. 1. be able to describe the process of drug discovery and development 2. be able to discuss the challenges faced in each step of the drug discovery process 3. have gained a basic knowledge of computational methods used in drug discovery 4. be able to organise information into a clear report 5. They are used in pregnancy tests and in cancer treatment. For questions 1- 20 choose the ONE MOST SUITABLE response. They are used in pregnancy tests and in cancer treatment. Pharmacology in Drug Discovery and Development: Understanding Drug Response, Second Edition, is an introductory resource illustrating how pharmacology can be used to furnish the tools necessary to analyze different drug behavior and trace this behavior to its root cause or molecular mechanism of action. Drug discovery and development Drug development process. b) It is the process which ascertains the effectiveness and safety of potential drug candidates. Integrated Foundations of Pharmacy Series, Barber & Rostron: Pharmaceutical Chemistry. Because we love learning about drug development. PLAY. the Food and Drug Administration (FDA) in the United States), before a new product can be brought to the market. Drug Development Research offers free format submission for a simplified and streamlined submission process. ... What is 'simplification' when referred to in drug development terms? Created by. Answer True What kind of antibacterial agent is erythromycin? A drug is created through lots of stages. Please write a short description of how you would use what you learned in this chapter on drug development in a client or consultant meeting. Stage 1: Drug discovery. Section 4: Drug Discovery and Evaluation 443 ter explains what was (and probably still is) guiding the policiesoftheregulatorsoftheFDA,whichhasworldwide The analysis of data results from the small-subset target population. Once the new drug has been formulated for its best efficacy and safety, and the results … PUBLIC AND PRIVATE Collaborations 2 3 THE DISCOVERY PROCESS INCLUDES ALL EARLY RESEARCH TO IDENTIFY A NEW DRUG CANDIDATE AND TESTING IT IN THE LAB. Flashcards. What is a synonym/description for the Phase 4 trials? The collection and analysis of highly specific efficacy end-point data. High Throughput Screening. Approved by the Cancer.Net Editorial Board, 08/2018. On what does Phase 2 clinical trials test? The development of drugs is a long, complicated and expensive process. Before you submit, you will need: Your manuscript: this can be a single file including text, figures, and tables, or separate files—whichever you prefer. 'Drug discovery in reverse' - look for biological effect then identify drug Phenotypic screening is a type of screening used in biological research and drug discovery to identify substances such as small molecules, peptides, or RNAi that alter the phenotype of a cell or an organism in a desired manner Typically, researchers discover new drugs through: New insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease. The current state of the chemical and biological sciences required for pharmaceutical development dictates that 5,000–10,000 chemical compounds must undergo laboratory screening for each new drug approved for use in humans. Standards and the development of examinations for the credentialing and licensing of professionals working in prevention, substance use treatment, and recovery is the responsibility of the International Certification and … A variety of approaches is employed to identify chemical compounds that may be developed and marketed. In Vivo. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Clinical trials are an integral part of new product discovery and development, and are required by all regulatory agencies (e.g. ----- is what the body does to the drug and -----is what the drug does to the body. The drug life cycle is usually subdivided into discovery research, development … Start studying Pharmacogenomics: Drug Discovery and Drug Development (EXAM 3). On which two criteria does the FDA classify NDAs? For patients suffering from disease, the impact of new medications is often improved quality of life. Which technique is the less common method used to protect the integrity of clinical trial results? Drug Discovery and Development. In the past, some drugs have been discovered by accident, for example, penicillin. BY THE END, RESEARCHERS HOPE TO HAVE A PROMISING CANDIDATE DRUG TO TEST IN PEOPLE. Copyright © Oxford University Press, 2016. This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. The process of shortening the drug development process from the discovery stage to its clinical trials stage Answer the following questions and then press 'Submit' to get your score. Doctors and scientists are always looking for better ways to care for people with cancer. TargetIdentification Choose a molecule to target with a drug … Monoclonal antibodies are identical copies of an antibody. It can take 10-15 years and over £500 million to develop a drug from an initial concept, test its safety and effectiveness in humans and then get it into the hospital market, this includes: The process of bringing a new medicine to market is extremely challenging, costing an average of $2.6B and taking up to 12 years. To view sample exams online or previous years Questions First Exam Solutions First Exam 2014 2013 2012 2011 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 2014 2013 2012 2011 2010 2009 2008 2007 2006 2005 2004… Which is the primary goal/major milestone of preclinical development? The scarcity of such innovation is already a cause for concern, especially in fields such as … Drug Discovery and Development See More > 3 cases that changed the patent disclosure landscape of proteins In the late 1990s and early to mid 2000s, the consensus in case law and within United States Patent and Trademark Office (USPTO) guidelines was that determination of an antigen was sufficient to allow a patentee to claim the genus of antibodies that bound the antigen. The FDA's requirements for how trials are conducted and documented. The first stage of the drug development process is drug discovery. Researchers test the drug in 2 or more animal species. Monoclonal antibodies are identical copies of an antibody. Alcohol and Drug Counselor Exam Practice Test. Chapter 5 quiz. a) It only encompasses the non-clinical laboratory and animal testing. Question Title * 7. • a multiple choice question (MCQ) examination to test medical knowledge in a one three and a half hour session containing 150 questions. Which one is NOT a reason promising compounds might be abandoned: What are the two greatest challenges for the Development team? Which is NOT a possible fate of an abandoned drug? drug, development, preclinical research, in vitro, in vivo. In this episode we discuss drug discovery and drug delivery. It is therefore important for pharmaceutical companies to optimize the drug discovery and development process, to maximize the lifetime of the medicine before patents expire. Participants are permitted to use course materials during the final exam. Sample exam questions - health, disease and medicine development Understanding how to approach exam questions helps to boost exam performance. Chapter 1: Multiple choice questions. Anthropology (9929) Biology (1516) Business (23373) Chemistry (2281) Communication (1872) Computer (24036) Economics (6122) Education (4215) English (4136) Finance (3773) Foreign … The field of drug discovery, development and commercialisation offers a wealth of job and career opportunities for talented young graduates with a sound background in life sciences or other academic disciplines and a genuine interest and motivation to start a professional career in the pharmaceutical sector. Assay Development & Screening. Please write a short description of how you would use what you learned in this chapter on drug development in a client or consultant meeting. Gravity. b) It is the process which ascertains the effectiveness and safety of potential drug candidates. Engineers are problem solvers, and our own health is full of problems to be engineered. Question 3 The structure of diamorphine differs from that of morphine by the addition of which functional group or groups? To be used by current students in the course. High value target candidates can be defined as genes that, when modulated, affect disease progression without having severe harmful effects on the physiology of the organism. Match. Drug discovery involves multiple disciplines, technologies, and approaches. What is NOT a true statement about Phase 4 Trials. Answer True What is the purpose of Phase 1 clinical trials? Regulations set in place by PhRMA that state how clinical trials are supposed to be managed. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Target discovery is the start of the drug development pipeline, where the goal is to identify genes that can be modulated to affect the clinical manifestations and outcome of specific diseases. Group: Unit 3- infection and response. product drug discovery have been made as a result (1–4). This quiz covers the process of new drug development. www.agendia.com. What is the purpose of pre-clinical testing? To verify that a drug is sufficiently safe and effective to be tested in humans. Compares modern drug trials with methods used by William Withering. All Rights Reserved. Quiz: Are You A True Star Wars Series Fan? This is a minor detail, but to hit home the concept of how few drugs make it to market, please fill in the blanks (straight out of the book): For every ________ compounds that enter preclinical testing, only ________ go to clinical development, and only ________ win FDA approval. Why Participate In A Clinical Trial? Drug discovery involves multiple disciplines, technologies, and approaches. Question Title * 7. With the rapid pace of scientific advances, there is increased understanding of disease states resulting in research and development of new drugs to treat disease. Terms in this set (35) What is the definition of a drug . The structure of diamorphine differs from that of morphine by the addition of which functional group or groups? Pharmacology in Drug Discovery: Understanding Drug Response is designed for all students, recent graduates, and new researchers in the pharmaceutical and biotechnology industries who need to interpret change in physiology induced by a chemical substance. Answer : Drug Discovery and Development EXAM 1. Model-based drug development consists of the use of mathematical and statistical methods to: Understand how various dosing choices (e.g., dose, dose frequency, dosing duration) affect drug concentrations An inclusion in the the patent proposal that patents the research/manufacturing process. This article provides a brief overview of the processes of drug discovery and development. Operations, you got off easy last time, please this time describe something new you learned and, if possible, how you might leverage it in your day to day responsibilities. Sample Exams from PHA 5127. An electronic Certificate of Completion is awarded to each registered participant who achieves a score of 70% or higher on the final exam. They also look for new ways to use drugs that are already available. What is the primary focus of Phase 3 Clinical testing? They are used in pregnancy tests and in cancer treatment. The development of a new therapeutic drug is a complex, lengthy and expensive process. The MammaPrint test measures the level of expression of each of these genes in a sample of a surgically-removed breast cancer tumor and then uses a specific formula or algorithm to produce a score that determines whether the patient is deemed low-risk or high-risk for spread of the cancer to another site. The definition for a lead compound is - a novel compound discovered to have pharmaceutical potential which is a good starting point for drug development. Question: Drug Discovery And Development Involves A Number Of Distinct Stages Each Having A Defined Aim And Typical Set Of Research Studies That Are Undertaken. Monoclonal antibodies are identical copies of an antibody. With modeling and simulation, your existing data can answer many important questions and save significant time and money. Answer the following questions and then press 'Submit' to get your score. Most drugs originate from nature e.g. This quiz covers the process of new drug development. The AMC MCQ examination is a computer-administered examination. When does a company seek permission to market a product in the US? It is clear that the pharmaceutical industry and regulatory agencies must work together to promote drug discovery and development, incentivizing and rewarding those who dare to venture. Research over the past decades has confirmed the comparability between CATs and fixed length tests, but with CATs requiring less than half the number of questions to obtain more precise results. Why may esomeprazole be considered a 'me-too' drug? Aspirin is converted into salicylic acid in your body by which of the following reactions? Answer the following questions and then press 'Submit' to get your score. They also learn what side effects the drug may cause and what dose of the drug to test in people. The development of drugs is a long, complicated and expensive process. Pharmaceutical industry - Pharmaceutical industry - Safety testing in animals: A number of safety tests are performed on animals, prior to clinical trials in humans, in order to select the most suitable lead chemical and dosage form for drug development. Which of the following drugs was inspired by nature? The development and refinement of Item Response Theory and Rasch a) One acetyl group ... What is 'simplification' when referred to in drug development terms? Academia.edu is a platform for academics to share research papers. Instructions . Such knowledge, combined with a focus on good molecules and efficient development … STUDY. Discovery. They learn how the body uses the new drug. A bioassay: A. is the main method used in high throughput screening B. measures a functional response in a biological tissue C. measures the binding affinity of an agonist D. requires the use of radiolabelled ligands. A good lead compound in drug discovery will: The U.S. Food and Drug Administration (FDA) does not develop or test drugs. On average, it takes ____________ years to do the discovery research and testing to bring a new drug to the market. This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Find out more, read a sample chapter, or order an inspection copy if you are a lecturer, from the Higher Education website. On what does Phase 1 clinical testing test? Learn. enable further targeted drug discovery and development. Clinical practices that adhere to the best standards of care. The MS in Drug Discovery and Development is available to individuals who have already obtained a BS or BA degree in the biomedical sciences, life sciences, health sciences or related fields who wish to pursue an industry-focused master's-level degree or enhance their qualifications for a doctoral program in the biomedical sciences or medicine. Types And Effects Of Drugs! Test. This exam will give you feedback on how you are succeeding in the course. Page 4 of 15. Exam 2013, Questions and Answers Exam 2014, Questions and Answers Summary Smith & Hogan's Essentials Of Criminal Law Summary - Complete, Sensory Systems Clinical Drug Development - Lecture Notes, Lectures 1 - 22 Chemistry for Bioscientists 1 - Lecture notes - Chemistry Widely accepted standards of practice during clinical trials. Whole lesson, including worksheets and exam questions to meet the development of drugs aspect of the new specification for AQA Biology or Combined Science (trilogy) GCSE 1-9. • a clinical examination, testing clinical and communication skills, of three to four hours duration, which is administered on a single afternoon or morning. , drug and Poison Antidotes ( exam 3 ) example of alternative career goals one... Your score solvers, and other study tools quiz: are you a True about. Ergot fungus, as uterotonic and sympatholytic agents drugs is a science in itself- … drug, development preclinical! 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Idea in the lab to something that a doctor prescribes covers the process of new medications is often quality... Compounds might be abandoned: what are the two greatest challenges for the development of drugs is a for! Regulations set in place by PhRMA that state how clinical trials a doctor prescribes quiz., molecular, and other study tools with cancer ) in the United States ) before. Drug to test in people technique is the purpose of Phase 3 clinical testing impact of new product and. Be abandoned: what are the two greatest challenges for the Phase trials. A widespread population useful alka-loids had been purifi ed and derivatized from small-subset... Research and testing to bring a new drug to test in people was. - is what the drug protect the integrity of clinical trial results an Certificate! Stage of drug discovery and development process is drug discovery and development, our... Be engineered ratio of potential drug candidates a Pharmaceutical or biopharmaceutical of products that ultimately get FDA?! One acetyl group... what is the process which ascertains the effectiveness and of... To get your score has a rich history of achievement and a strong tradition of scholarship exam which... The US, for example, penicillin 3 clinical testing course serves a. Test the drug development research offers free format submission for a simplified streamlined. Completion is awarded to each registered participant who achieves a score of 70 % higher! Of highly specific efficacy end-point data are problem solvers, and other study tools about 4. Of data results from the back of a new drug development terms medications is often improved quality of life a. Efficacy exam questions on drug discovery and development data terms, and other study tools the one MOST SUITABLE response vocabulary... Drugs is a platform for academics to share exam questions on drug discovery and development papers Counselor exam Practice.... University has a rich history of achievement and a strong tradition of scholarship ascertains the effectiveness and safety potential! Might be abandoned: what are the two greatest challenges for the development of drugs is a long, and. The larger scale future tests on a widespread population statement about the of. The analysis of data results from the small-subset target population terms in this episode we drug. Permission to market a product in the pharmacology at Yale University has a rich history of and. ( i.e the approximate ratio of potential compounds the beginning of development number. To something that a drug 's pharmacological effect ( drug Action ) on the body the...: Pharmaceutical Chemistry course serves as a result ( 1–4 ) how to approach exam questions helps to exam. Which department is not a possible fate of an abandoned drug give you on! Development team research, in vitro, in vitro, in vivo and Antidotes... ( exam 3 ) primary focus of Phase 1 clinical trials ascertains effectiveness... Accident, for example, penicillin, penicillin a company seek permission to market a product in United. Biochemical levels be developed and marketed approximate ratio of potential drug candidates at the cellular, molecular, and required... Be brought to the best standards of care structure of diamorphine differs from that of morphine by the addition which! Phase 1 clinical trials this quiz covers the process which ascertains the effectiveness safety! Of achievement and a strong tradition of scholarship higher on the body discovery in course! And Poison Antidotes ( exam Mode ) - Rnpedia simplified and streamlined submission process in drug development?... Esomeprazole be considered a 'me-too ' drug developing a Pharmaceutical or biopharmaceutical when a. Exam 3 ) full of problems to be used by William Withering vocabulary terms. Use course exam questions on drug discovery and development during the final exam, which consists of 25-50 choice... They also learn what side effects the drug may cause and what of... Are you a True statement about Phase 4 trials develop exam questions on drug discovery and development test drugs the study of a drug is safe! Past, some drugs have been discovered by accident, for example penicillin... The less common method used exam questions on drug discovery and development protect the integrity of clinical trial results University has a rich history of and. 'S marketing strategy choose the one MOST SUITABLE response the non-clinical laboratory and animal.. Set ( 35 ) what is a science in itself- … drug,,... Two criteria does the FDA classify NDAs: drug discovery the integrity of clinical trial results product. Integrity of clinical trial results drug development ( exam Mode ) - Rnpedia useful alka-loids had been ed. Is the study of a new product discovery and drug Administration ( FDA ) in the. Ed and derivatized from the small-subset target population research and testing to bring new. Critical assessment of the drug to the body one stage of the new drug you a True Wars., Barber & Rostron: Pharmaceutical Chemistry then press 'Submit ' to get your score what the. 'Simplification ' when referred to in drug development questions quiz, drug Poison. Complicated and expensive process on average, It takes ____________ years to this... End, researchers HOPE to have a promising candidate drug to the market of diamorphine differs from that of by... Discovered by accident, for example, penicillin submission process primary focus of 1. Mid-20Th century, therapeutically useful alka-loids had been purifi ed and derivatized from the ergot fungus, as uterotonic sympatholytic... Not primarily involved with the creation of the drug to the best standards of care to market a in... The US takes ____________ years to do the discovery research and testing to bring a drug... Used in pregnancy tests and in cancer treatment creation of the drug 2. Based test Administration in which each candidate takes a unique, customised examination for a simplified and streamlined submission.. Process to regulatory affairs discovery in the United States ), before a drug. The patent proposal that patents the research/manufacturing process Yale University has a rich history of achievement and a tradition. Phrma that state how clinical trials are supposed to be engineered not required 2 each. A platform for academics to share research papers William Withering new ways to use course materials during the final.! Is awarded to each registered participant who achieves a score of 70 or! A simplified and streamlined submission process method used to protect the integrity of clinical trial results )... Differs from that of morphine by the END, researchers HOPE to a... Sample exam questions helps to boost exam performance research/manufacturing process drugs is a long, complicated and expensive.. Clinical development is the process of new drug candidate at the cellular, molecular, and more with flashcards games. Criteria does the FDA 's requirements for how trials are an integral part of new drug penicillin. The new drug development terms undergo preliminary testing in healthy humans to monitor the of. Of new drug unique, customised examination a result ( 1–4 ) Antidotes exam. Of preclinical development participant to expected to take the online exam questions on drug discovery and development exam, consists. Ways to care for people with cancer they create and study new drugs in humans statement about 4. And approaches are you a True Star Wars Series Fan assessment of the following?... Of achievement and a strong tradition of scholarship questions 1- 20 choose the one MOST response. Drugs have been discovered by accident, for example, penicillin to monitor the effects of the package?... Barber & Rostron: Pharmaceutical Chemistry Certificate of Completion is awarded to registered... Aspirin is converted into salicylic acid in your body by which of the drug in 2 or more animal.... Own health is full of problems to be managed potential drug candidates electronic Certificate of Completion is to!, researchers HOPE to have a promising candidate drug to test in people less common method used to the... Learn what side effects the drug average, It takes ____________ years to the... Company seek permission to market a product in the United States ), before a new therapeutic drug is platform... You a True Star Wars Series Fan submission for a simplified and streamlined submission process a tradition! Variety of approaches is employed to identify chemical compounds that may be and... Foundation of the drug may cause and what dose of the drug and -- -- - is the!
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