...Tobacco Clinical Trials Name Instructor Institution Laboratory testing In the laboratory, chemical tests are conducted to assess the extent to which the level of toxicants from the new tobacco modified product will reduce as compared to the ordinary produced tobacco cigarettes, biological tests are also conducted to plot the early indication of whether the newly modified tobacco products provide assurance that the risk of harm will not be increased at an expense of other factors(Rees, et al., 2009). In practice, some of the laboratory testing methods and techniques has already been developed. Only the necessary amendments are required determine the effects of creating a new product from tobacco that's modified to provide salbutamol sulfate, also known as albuterol.Laboratory testing of the modified tobacco product may involve three methods; I. Use of models such as mouse II. Using prototypes such as machines III. Use of real humans(The Trustees of the University of Pennsylvania, 2009) Mouse models may be useful in pharmacology and molecular biology to elucidate the behavioral and molecular basis of effective and cognitive signs of nicotine withdrawal. Mouse can mimic individual biologically induced behavioral deficits that are hypothetically associated(Tobacco Products Scientific Advisory Committee, 2012). This is because they have some genes similar to those in humans and therefore may be of great importance in this set up. However, mice are not always reliable...
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...Julian Jane Atim, MBChB, MPH Uganda Health Marketing Group (UHMG) Stephanie Cantu Harvard Medical School Jonelle Wright, PhD, RN University of Miami Introduction This module consists of four (4) sections. After completing the training, you will take a short quiz on the training content. After completing the quiz, we ask you to answer a few optional questions to give your view of this training module. Learning Objectives By the end of this module, you should be able to: Describe the concept of Cultural Competence in Research Explain the importance of Cultural Competence in Research Describe ways to enhance the engagement of diverse populations and communities in research Identify cultural competence challenges faced by researchers when working with culturally diverse populations Cultural Competence in Research Culture is fundamental to everyone's perceived identity. It is a mix of one's values, beliefs, standards, norms, behaviors, language, communication styles, and thinking patterns.[1] Cultural competence refers to understanding the importance of social and cultural influence on the beliefs and behaviors of the patient, student, colleague or client.[2] Cultural competence in health care describes the ability of systems and health care professionals to provide high quality care to patients with diverse backgrounds, values, beliefs, and behaviors, including communicating effectively and tailoring delivery to meet patients' social, cultural and linguistic...
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...Cassandra Jones Professor Rhonda Hill HSA 500 January 21, 2012 Health care issues in the United States have escalated to the point of a crisis for all except the richer Americans. Health care expenditure is the major component of household consumption responsible for the increase in household net borrowing and even the foreign deficit (Singer, 2008). The health care system in the United States has evolved in many important ways over the last 50 years, an evolution that is important to document and understand if today’s system is to be fully understood (Williams & Torrens, 2010). There are a number of behaviors and daily lifestyle patterns that have a major affect on our health. For example, driving recklessly, abusing alcohol, tobacco smoking and illegal drugs. All of these behaviors have a negative effect on our lives. There is always something in the news about a major car accident, which involves drunk drivers. One needs to cut down on these items in order to live a stress-free and happy life. Unhealthy behaviors become habits, so changing them can be very hard. You’re more likely to make changes in your habits if you set a specific goal for yourself (“Healthy living”, 2010). Your health is not only affected by your behavior but also by economic and your social structure. While health care reform remains an important consumer issue and the U.S. policies continue to focus on accessibility and affordability of health care, it is critical to understand the patterns...
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...CORPORATE SOCIAL RESPONSIBILITY IN THE PHARMACEUTICAL INDUSTRY: BETWEEN TREND AND NECESSITY by Cecile Oger BSc. (Honours) Chemistry with Business Administration Kingston University London, UK, 1995 A thesis presented to Ryerson University In partial fulfillment of the requirements for the degree of Master of Business Administration In the program of Master of Business Administration Toronto, Ontario, Canada, 2009 © Cecile Oger 2009 Library and Archives Canada Bibliothèque et Archives Canada Published Heritage Branch Direction du Patrimoine de l’édition 395 Wellington Street Ottawa ON K1A 0N4 Canada 395, rue Wellington Ottawa ON K1A 0N4 Canada Your file Votre référence ISBN: 978-0-494-59035-5 Our file Notre référence ISBN: 978-0-494-59035-5 NOTICE: AVIS: The author has granted a nonexclusive license allowing Library and Archives Canada to reproduce, publish, archive, preserve, conserve, communicate to the public by telecommunication or on the Internet, loan, distribute and sell theses worldwide, for commercial or noncommercial purposes, in microform, paper, electronic and/or any other formats. . The author retains copyright ownership and moral rights in this thesis. Neither the thesis nor substantial extracts from it may be printed or otherwise reproduced without the author’s permission. L’auteur a accordé une licence non exclusive permettant à la Bibliothèque et Archives Canada de reproduire, publier...
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...The Business of Developing New DrugsThe Business of Developing New Drugs for Cancer Larry Cephas Strayer University Developing new drugs for cancer and or any other medical purpose is a tedious, complex, expensive process. The process in developing new drugs involves numerous stages of trial and error. According to Mahajan and Gupta (2010) on average it can cost anywhere from US$ 802million to US$ 1billion dollars to successfully develop and market new drugs and, that process can take up to 12years with on average of only 8% of them ever hitting the market. From the beginning of civilization, people have been concerned regarding the quality and safety of medicines, which I do not fault anyone because, some medicines just do not work out to be very effected and good for the human body. My purpose of this white paper is to inform you and outline the various steps and procedures that goes into developing these new drugs for cancer, the economic issues people with face today, the special needs being served and the benefits of these new drugs and methods of how they are being developed, and finally based on my research the end result once these newly developed drugs reach the consumers. The Development of New Drugs The steps involved in developing new drugs for cancer patients are very complex (Figure 1). According to a fact sheet released by the California Biomedical Research Association there are several steps taken when developing a new drug. The first step involved is...
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...Are Controlled Clinical Trials Really Ethical? Case Study In 2009, two cousins, Thomas and Brandon were diagnosed with the same type of deadly skin cancer within a 2 month time frame of each other. To date, here is no cure for skin cancer and once diagnosed the average life expectancy is approximately 8 months. Current standard of care treatments are aimed at shrinking the tumors and prolonging life. Unfortunately, these standard of care treatments only work in a very small percentage of patients and are very toxic with terrible side effects. Thomas learned of a new Phase 3 clinical research trial sponsored by Roche with an unapproved yet promising drug. His doctor explained that in earlier trials, a majority of volunteer patients who took the wonder drug had seen a drastic reduction in the size of their tumors with very few side effects. The only way ill patients can get the drug is by participating in this trial. The trial is a randomized controlled trial (RCT) which means half of the volunteers will get the experimental drug while the other half will be treated with another standard of care treatment. The purpose of the standard or control arm is to allow researchers to compare the long term effects of the new drug to that of the current standard treatment and determine whether it actually shrinks tumors and prolong remissions. Participants have a 50/50 chance of being placed in either arm of the study. Arm assignments are random and cannot be changed. With limited options...
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...environment and dealing with occasional aggression in a sensitive and effective way, I will be able to plan and deliver patient care within the health care team. Also I will use my communication and interpersonal skills to emphasize with SU and understand their problems; willingness to be adaptable, flexible and support SU’s to ensure that they have a good care delivery. I will monitor relevant research to improve quality of care and seek consultation when appropriate to enhance own practice. I will engages in and collaborate with other in the conducting research to discover and examine knowledge and evidence based approaches to practice, also recognise the importance of learning to be knowledgeable of relevant research and advances in clinical practice. Part of the professional development is...
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...There are several innovative things that have been popularized over the past few decades. To name a few, there are: digital cameras, the Internet, and the Nintendo Wii. I have decided to discuss Viagra because I think this was an accident as well as a miracle for certain individuals with E.D. The reason I say that this medication was found by accident is because it was originally intended for high blood pressure patients, but it was discovered to be very helpful to males that had E.D. It enabled men to take back control of their sex lives with the aid of a little blue pill (Parnham, 2004). If this is not considered innovation, then what is? When the primary clinical trials happened, Viagra didn’t have a lot of effect on patients with hypertension; however, it gave males an erection. When the second clinical trial took place, they chose to keep using Viagra to treat E.D. This medication was patented during 1996, and was presented to the United States where it was approved to treat E.D. in March of 1998 (Parnham, 2004). Intrapreneurship was exhausted in presenting Viagra. One pro of exhausting the Intrapreneurship approach is the fact that developing Viagra was paid for by Pfizer, the creator of Viagra. The fact that there was...
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...organizational improvements can help. The research highlights some important considerations to be aware of that gives evidence-based medicine a bad name, the pitfalls to avoid, and some ways providers and institutions are working to overcome them. Introduction This paper begins by giving an overview of evidence-based medicine, what it is, and the benefits to be realized by providers, insurers, and patients. I compared that to what providers were using before EBM. Next, I examine the barriers to successfully incorporating evidence-based medicine, and the negative perceptions that dissuade their use by clinicians. Identified are the disadvantages such as source information bias, ethics considerations, and the dangers in using EBM to set Clinical Practice Guidelines (CPG). The research highlights some important considerations to be aware of that gives evidence-based medicine a bad name. I looked at pitfalls to avoid and some ways providers and institutions are working to overcome them. Finally, I included an overview, from a pharmacy management perspective, of how improvements techniques...
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...CLASSICAL CONDITIONING Classical Conditioning: Raspberry Diet Carolyn Crump Psychology 103/Point University Abstract Classical conditioning can be, and is, used and applied every day. It was discovered by Ivan Pavlov through his studies on physiology of digestion in dogs, but classical conditioning, as it applies to learning and behavior, has nothing to do with salivating dogs. Pavlov’s contribution was just the catalyst for later discoveries. Clinical trials and studies used to educate researchers looking to improve the lives of people are generally a good ideal. The raspberry ketones is an example of classical conditional after Dr. Oz says you will lose weight if you take this pill and subscribes raspberry ketones as his # 1 “miracle in bottle” fat buster, and the supplements has been flying of the shelves. Classical Conditional Raspberry Diet Classical Conditioning: Raspberry Diet After being mentioned on Dr. Oz, the sales of Raspberry Ketone have gone through the roof. This is in part due to the clinical study that was mentioned on his website. To be clear, Dr. Oz does not endorse any specific raspberry ketone product, but this study was mentioned on his website and can be used as a guideline. The New Year with new goals to lose weight and you just heard that Dr. Oz is saying that Raspberry Ketone is way to go to new you is a prime example of the unsolicited responses triggered by nonrelated stimuli is the result of Classical Conditioning, which is the exact...
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...After reading the passage, I realized a few ethical violations could be recognized. Before a study or research could be conducted, all participants should be informed on the purpose of the research, what procedures are involved, benefits of the research and any risks related to the research. In psychology, one of the professional codes of ethics is that all participants must consent to the research and must be debriefed. In the Guatemala study, female commercial sex workers were injected with diseases such as gonorrhea, chancroid, and syphilis without their prior knowledge and consent. Secondly, the soldiers and prison inmates were infected with the disease by having sex with the infected sex workers without knowledge of them being infected or being participants in a research. Additionally, when the researchers found out that the soldiers were infected by the female commercial sex workers, they changed their approach by infecting them with gonorrhea through inoculations into the urethra, skin injections of chancroid and syphilis and also exposing the foreskin of the penis to other infectious material. This is again was done without their consent, hence they were decepted. Another code of ethics is the protection of the client’s welfare. Human participants should not be infected or injected, or put in any harm. Researchers must ensure that participants taking part in a research must be protected from physical and mental harm. For example, participants should not be exposed...
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...Vol. 20, No. 2, May 2011 Clopidogrel copy products in Indonesia are bioequivalent to Plavix® 149 The importance of bioequivalence study: focus on clopidogrel Arini Setiawati Department of Pharmacology & Therapeutics, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia Abstrak Studi bioekivalensi (BE) diperlukan untuk menunjukkan apakah suatu produk copy dapat menggantikan produk inovator. Tujuan makalah ini adalah untuk menjelaskan alasan melakukan studi BE, produk-produk utama yang memerlukan studi BE, serta desain dan pelaksanaan studi BE, dengan fokus pada klopidogrel. Semua produk generik klopidogrel di Indonesia telah ditunjukkan bioekivalen (BE) dengan produk inovatornya, Plavix®, dan mereka mengandung bahan baku klopidogrel form 1 yang memenuhi persyaratan USP 30, 1997: kandungan enansiomer R tidak lebih dari 1%. Bukti bahwa bioekivalen (BE) berarti ekivalen secara terapeutik (TE) juga ditunjukkan untuk obat-obat kardiovaskular. Klopidogrel mempunyai 2 bentuk polimorfik, form 1 dan form 2, yang mempunyai indikasi yang sama. Sedikitnya satu studi klopidogrel yang pivotal, CAPRIE, menggunakan klopidogrel form 1. Suatu kejadian aterotrombotik mungkin berhubungan dengan resistensi terhadap klopidogrel, yang terjadi pada sekitar 4 sampai 30% pasien yang diobati dengan dosis klopidogrel yang biasa diberikan. (Med J Indones 2011; 20:149-53) Abstract Bioequivalence (BE) study is required to show whether a generic copy product can be interchangeable with...
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...never forget that the hospital can be a scary place typically associated with illness, injury and death and therefore can have a negative image. Sometimes a kind word, a smile, a few extra moments, a touch or just an ear to listen is all it takes to give a little reassurance to our patient that we are care for them. I guess you could say this is the same as the “Golden Rule” and I would be hard pressed to disagree because more often than not I have been on the receiving end of nursing care and have benefited from nurses who have taken time to offer those reassurances and been made more uneasy by nurses who are just shuffling through their busy day getting their “tasks” done all around me. I believe all nurses no matter how busy with the clinical practice of nursing should never forget the humanitarian aspect of nursing because we will all be touched by a nurse in one way or another in our...
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...Topic 1: The Most Important Health Issue In Australia 2013, Dementia. Dementia is a broad term that encompasses a large group of illnesses that cause a progressive cognitive functional decline including memory loss, loss of intellect, rationality, language skills, perception, social skills and physical function. Dementia exists in many different forms including Vascular Dementia, Frontotemporal Dementia, Dementia with Lewy Bodies & the most common form of Dementia, Alzheimer’s Disease. (“Key Facts and Statistics,” 2013.) Dementia affects Australians of many ages and although Dementia is not considered a normal aspect of the aging process, approximately 92% of Australians diagnosed with Dementia are over the age of 65 years. ("Alzheimer’s disease is not a normal part of ageing,” 2012) It is estimated that there are currently over 321,600 Australians living with dementia and approximately 1,700 new cases of dementia diagnosed every week. I believe these incredible statistics combined with Australia’s rapidly aging population make Dementia Australia’s most important health issue in 2013. (“Key Facts and Statistics,” 2013.) The table below highlights the projected population growth & rapidly aging population facing Australia up to 2031. Table 1; [pic]“(Note: Reprinted from (Challenge 1, Community Services & Health Industry Skills Council,” n.d.) Australia’s rapidly aging population will see the number of Australians living with dementia increase by...
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...2013 RES 351 University of Phoenix Prof. Lara Lucas Unethical Research Two employees of Lee Research of Lenexa Kansas were indited for falsifying research information. The research company was contracted by Schering/Plough, a subsidiary of Mereck & C, to conduct clinical trails of a new allergy medication. The trials were conducted from January 2010 to May 2010. Dr. Wayne Spencer, a licensened physician and the principle investigator of the study, along with Lisa Sharp, the director of clinical trials at Lee Research Institute were named in the inditement.Dr. Spencer and Sharp were each charged with one case of conspiracy, three counts of mail fraud, and one count of falsifying information required by the Food and Drig Administration (Pharmalot.com, 2011). Dr. Spencer and Sharp were terminated by Lee Reasearch Institute following the inditements. Lee Research Institute immediately started an internal investigation of the alledged insedence in cooperation with the Food and Drug Administration and Schring/Plough (Kansas City Business Journal, 2011). The indictment accuses the two former employees of providing false information of the patients participating in the study trials. The study was to be conducted using subjects 50 years old or greater who suffer from ragweed allergies. Employees of the contracted research organization were prohibited from participation in the case study. Dr. Spencer and Sharp are accused of falsifying the information of the participants...
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