Thursday, January 30, 2020

Second Hand Smoke Essay Example for Free

Second Hand Smoke Essay Second hand smoking has become a major problem in today’s society, and it must be changed. Although there are multiple solutions to second hand smoke some solutions include establishing separate ventilation systems in each and every restraint, planting more trees, and establishing more oxygen rich sources in areas where smoking is engaged and to ban smoking in outdoor areas. Every day between 70% and 90% of non-smokers in the American population, children and adults, are regularly exposed to secondhand smoke. It is estimated that only 15% of cigarette smoke gets inhaled by the smoker. The remaining 85% lingers in the air for everyone to breathe. (University of Minnesota, 2003). Every year tobacco use kills more than five million people every year, more than HIV, AIDS, Tuberculosis and malaria combined. (World health organization, Dec 2009). But it does not have to be this way, with a few simple changes thousands of lives could be saved. Smoking causes an estimated 90 % of all lung cancer deaths in men and 80 % of all lung cancer deaths in women (CDC, 2012). Smoking is also estimated to increase the risks of coronary disease and strokes by two to four times. CDC, 2012). But smoking also harms second hand smokers too, it is estimated that second hand somek contains over 4000 chemicals including more than 40 cancer causing agents and 200 known poisons (university of Minnesota, 2003). But should the innocent by stander really have to put his or her health at risk in order to allow the smoker to have stress control or satisfy their nicotine craving? Every day millions of families dine out at restraints across the country. Most of them having small children. Most restaurants have adopted a non smoking policy, but some still have not. For the restaurants that have not adopted a smoke free facility, they should have to implement separate ventilation, and separate sealed rooms, so the non smokers can still enjoy a fresh meal, and not have to worry about what is in the air they are breathing in. If separated sealed rooms so the non smokers can still enjoy a fresh meal, and not have to worry about what is in the air they are breathing in? If the separate ventilation systems were established, the major costs would be filters to maintain the system and ensuring smokers remained in the smoking section of the building. Other countries such as Ireland, Spain, New Zealand, Italy and Uruguay have all adopted smoke free establishments, and have had great success (World Health Organization, 2007). There is also no evidence that these bands have a negative economic impact on the hospitability sector (world Health Organization, 2003). The smoking section would have to be indoors to ensure that patrons that are outside of the restraint do not have to inhale cigarette smoke, many restaurants have a smoking area in front of their restraint, usually on a patio, but unfortunately smoke still lingers near the front entrance. And in most cases smoke still enters the inside of the restraint through sliding glass doors or tether non sealed entrances. My proposal would eliminate this problem by requiring sealed entrances, separate ventilation systems and not allowing smoking outside of the restraint entrances. One study has been conducted on separate ventilation systems removed some of but not all of the gas particles. (CDC 2012) The study also showed that ventilation systems did not remove all of the gas and particles from the cigarette smoke, but improved the air quality by 50 %. (CDC 2007). The substantial improvements from incorporation this would improve workers health, and the patrons that eat and or visit there. And in many ways it could improve the business for many establishments by catering to all patrons needs. Another proposal would be to establish smoking areas, and establish more oxygen rich sources such as trees, or plants around them. And in areas that this is not possible, I would propose to position an air filter in that area. To establish more oxygen rich sources such as trees, I would propose planting trees in the vicinity of the making areas, and issue grants encouraging businesses to plant more trees. And in places where this is not possible I would propose positioning massive air filters in the vicinity to recalculate the air, and clean out all the toxins. Thus smoking areas would be vastly improved. The only disadvantage of such proposal could be the cost of filters, cost of maintained and the possibility depending on the air purifier the noise coming from such filter. But the advantages would outweigh the disadvantages in the fact that something is being done about the second hand smoking. My last proposal would be to ban smoking in public all together. The benefits of such proposal would be enormous to not only the health of people but the environment. The health benefits of such proposal include better air quality, encouraging fellow citizens to quit smoking if they are smoking and decreased consumption of tobacco products (world health organization, 2003). According to the world health organization, only 100 % smoke free environments provide effective protection from second hand smoke (world health organization, 2003). Other benefits include lower medical costs, decreased risk of fires, higher productivity in the workplace and lower insurance premiums (world health organization, 2003). To enforce the ban on smoking fines could be implemented to discourage fellow citizens from smoking in public. The fines would have to be hefty enough to encourage smokers not to light up in public, and to encourage a healthier lifestyle. The fine would be between 250-300 dollars. And would be enforced by local police departments and other law enforcement. Such as substantial fine would discourage smokers from engaging in smoking in public places, and would also be steep enough to be taken seriously. Because most of the citiziens would not take a law seriously if it did not take from their pocket. Contrary to the belief, smoking bans do not infringe upon anyone’s rights as they are protecting peoples rights by regulating where to smoke, and where not to smoke. (World health organization, 2003). And they cost very little helping businesses and personal alike. In fact most smokers actually prefer a non smoking environment, and choose to eat at a smoke free environment (world health organization 2003). And once a smoker chooses to quit, it makes it easier to dine out at a smoke free restraint because it encourages them not to light up again. In conclusion smoking in public would dramatically increase the health of the nation as a whole. It has been shown that second hand smoke causes multiple health problems, and by encouraging a healthier lifestyle ti could dramatically improve the lives and health of all citizens involved. It has been shown that most smokers prefer a non smoking environment, and many smokers are encouraged to stop smoking after living in areas where smoking is banned. Most people in the world are non smokers and should not have to be exposed to second hand smoke, and smokers should have every opportunity afforded to them to quit.

Wednesday, January 22, 2020

Special Education Essay -- Education Teaching

Introduction Since the passing of The Individuals with Disabilities Education Act (IDEA), schools are required to serve all students regardless of their disability in a least restrictive environment. Due to increase in the number of students being identified and placed in general education classrooms, educators can expect to serve students with disabilities. It is important to understand the different types of disabilities, the characteristics of these disabilities, and causes; in order to ensure the success of students. This paper will define severe disabilities, mental retardation, traumatic brain injury, autism, and deaf-blindness. In addition, this paper will address the characteristics and causes of each disability. Definition of Severe Disabilities There are many different definitions used to define the meaning of severe disabilities, a general definition for severe disabilities is any disability that significantly limits a person's physical, mental or emotional performance, and requires ongoing extensive support in more than one major life activity in order to participate fully in education, community settings or work. According, to Heward (2009), severe disabilities includes, â€Å"students with significant disabilities in intellectual, physical, and/or social functioning, students that have multiple disabilities or deaf-blindness, students with severe mental retardation, severe emotional disturbance, and severe disabilities or health impairments are encompassed by the term† (p.453). Characteristics of Severe Disabilities Depending upon, the combination and severity of disabilities, and the age of the person with severe disabilities they may exhibit a wide range of characteristics, however, â€Å"one defining characteristic ... ...ents that has one or more disabilites. By having a better understanding of the defintion, characteristics, and causes of these disabiliteis educators can be better prepared to instuct their students. By gaining a better insight of theses students and how they learn, educators can use effective strategies to ensure the success of all students. Works Cited Heward, W. L. (2009). Exceptional children: An introduction to special education (9th ed.). Upper Saddle River, NJ: Merrill National Dissemination Center for Children with Disabilities. (2004). Disabilities Fact Sheet. Retrieved January 8, 2011 from http://www.nichcy.org/InformationResources/Documents/NICHCY%20PUBS/fs10.pdf National Institute of Neurological Disorders and Stroke. (n.d.). Traumatic Brain Injury Information Page. Retrieved January 8, 2011 from http://www.ninds.nih.gov/disorders/tbi/tbi.htm

Tuesday, January 14, 2020

Investigational New Drug Review Process

INVESTIGATIONAL NEW DRUG REVIEW PROCESS Investigational New Drug Review Process Prashanth Kumar Ponugoti Northeastern University INVESTIGATIONAL NEW DRUG REVIEW PROCESS Abstract Investigational New Drug (IND) review process begins from the time the sponsor files investigation new drug application and the purpose of the review is to confirm the safety and efficacy of the patient for the drug.Moreover in the process of review if the review committee notifies any deficiencies by the new drug then there will be a clinical however if there are no deficiencies the drug will be approved for new drug application and will be under continuous review to make sure , that the drug does not cause any potential harm. This entire step wise process of review is explained in the following paper INVESTIGATIONAL NEW DRUG REVIEW PROCESS The following flow chart gives an overview of the IND review process Applicant (Drug Sponsor)IND Review by CDER Statistical Pharmacology/ Toxicology Medical Chemistry Spo nsor Submits New Data Safety Review Safety acceptable for study to proceed Clinical Hold Decision Notify Sponsor Complete reviews Reviews Complete and Acceptable? Sponsor Notified of Deficiencies No Deficiencies Study Ongoing INVESTIGATIONAL NEW DRUG REVIEW PROCESS I. Applicant (Drug sponsor): An applicant or the sponsor is a person or a group who takes responsibility and initiates for the investigation of new drug.A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor. The sponsor may be an individual, partnership, government agency, private agency, or any other organization and moreover the sponsor does not conduct the investigation process unless the sponsor is a sponsor-investigator. The applications are submitted to Center for Drug Evaluation and Research (CDER) Food and Drug Administration Document and Records Section 5901-B Ammendale Rd. Beltsville, Md. 20705-1266 II.Investigational New Drug Application: Sponsor thinks about new drug application when he has a successful results in preclinical studies (The studies conducted in animals to find the use of drug in human and ensure safety and efficacy) in other words it is the step taken after the successful preclinical studies to continue further studies that is clinical trial in humans. During the conduct of preclinical trial, step by step information of the process is recorded as data and stored. Thus stored information is helpful in filling an IND. The information is as follows A. Animal Pharmacology and toxicology studiesB. Manufacturing Information C. Clinical protocols and investigators information Animal Pharmacology and toxicology studies: The studies conducted in animals to ensure the use of the product is reasonably safe for initial testing in humans. Manufacturing Humans: This is the information obtained from manufacturing, storage, composition, storage and stability, for manufacturing of drug substance and produ ct. Clinical protocols and investigators information: protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.Information on the qualifications of clinical investigators—professionals who oversee the administration of the experimental compound–to assess whether they are qualified to fulfill their clinical trial duties. The IND is not a marketing approval but The IND is the means through which the sponsor officially obtains this exemption from the FDA: however, its main intention is to detail the data that provide documentation that it is indeed reasonable to proceed with certain human trials with the drug. Types of INDs i. Investigator INDs ii. Emergency Use INDs and iii.Treatment IND After the submission of the IND to the Center for Drug Evaluation and Research (CDER) committee it checks thoroughly the medical, chemistry, toxicological, and statistical data INVESTIGATIONAL NEW DRUG REVIEW PROCESS The se terms are explained below in detail III. Medical Review: Medical also called as clinical review is conducted by medical officers or physicians to ensure the initial use of the drug in patients and are safe to use . This review is also conducted by the non medical officers based upon the data available from the re clinical studies.Medical review plays a major role in new drug review process and is an initiating step for the test of the drug in humans: however it is an important step to be conducted and based upon the results obtained from the review it has a further scope to apply for next steps that is to file new drug application. During this review process the medical reviewers or physicians evaluate the clinical trial protocol for to determine A. If the participants will be protected from unnecessary risks; and B. If the study design will provide data relevant to the safety and effectiveness of the drug.However the safety of the drug is taken by the sponsor during the phase I studies but during phase II, III, and IV Food and Drug Administration (FDA) must also ensure the safety of the medicament in humans for market approval. IV. Chemistry Review: Each review committee has an chemistry review department for reviewing the chemistry of the drug and the agenda of this chemistry department is to address issues related to drug identity, manufacturing control, and analysis. The reviewing committee ensures that the investigational new drug is adequately reproducible and stable.If the drug is neither adequately reproducible nor stable then the chances of approval for IND are less because they are not sure about the drugs action in the body, and don’t know what it does. So the major purpose of chemistry review is i. To ensure that the compound is adequately reproducible ii. To ensure that the compound is adequately stable In addition to this the sponsor should discuss any manufacturing and chemistry differences between the drug product proposed for the cli nical use and drug product used in animal toxicology studies.However these differences might affect the safety profile of the drug product and need to be stated if there are no differences. V. Pharmacology or Toxicology Review: This committee is a group of pharmacologists and toxicologists who evaluate the results of animal testing made during the clinical trial and compare it with the potential effects in humans. That is to ensure safety of the humans for the new drug. i. Pharmacology and Drug Distribution (21 CFR 312. 23(a)(8)(I)): This is nothing but absorption, distribution, metabolism and excretion of the drug in the animals.These results should be obtained by conducting them in animals, so it should be recorded with an example. Moreover this should not be a reason for the clinical hold because these rae the studies conducted in phase one of the IND and where FDA feels it as sponsor great responsibility factor for the drug in achieving safety and efficacy to the humans. ii. Tox icology Data (21 CFR 312. 23(a)(8)(ii)(a)): INVESTIGATIONAL NEW DRUG REVIEW PROCESS Toxicology data is required from both vitro and vivo studies, because particular studies depend upon nature of the drug and phase of human investigation.VI. Safety Review: After submission of the IND to the CDER then the committee takes about good 30 days to conduct review in every factor to achieve safety and efficacy and to avoid potential harm to the human. The review is an ongoing process however CDER notifies the sponsor immediately if there are any potential high risks associated with the drug upon usage in humans. If a notification is sent to sponsor then it is clear that the application is put on hold and the sponsor should conduct enough studies to clear the hold.This hold will be removed and allows the sponsor for further studies only when changes made to the clinical hold achieve the safety and efficacy and does not case potential risks. If the sponsor is not notified with any information from CDER from the day of IND submission to the 30 th day then on the 31st- day further study can be proceeded as submitted. VII. Clinical Hold Decision: The Clinical hold is issued in during the thirty day review period and this is due to the following factors 1. The drug causes potential harm to the humans 2.If drug is not having enough stability 3. The IND does not contain sufficient information required under 312. 23 to assess the risks to subjects of the proposed studies 4. The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives. And CDER can hold the studies during the initial phases of the studies that is when filed for IND if observes potential risks on the data submitted initially. The Clinical hold will be removed if the sponsor addresses the issue based on the hold before the order is removed.In addition the clinical holds are reviewed by higher authorities of CDER to assure scientific quality and consistency in the Center's clinical hold decisions. IX. Notify Sponsor: X. Sponsor Notified of Deficiencies XI. Study Ongoing Xii. Conclusion†¦.. Page 17 and page 18 lo matter unnnadhi †¦ use gooogle search for material if required and provide the refrence where ever u grab the material†¦Ã¢â‚¬ ¦ Refrences: http://www. accessdata. fda. gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm? fr=312. 42 http://www. fda. gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082022. pdf

Sunday, January 5, 2020

Culture Of The Maasai Tribe Of Kenya And Tanzania

This paper will discuss in great detail the culture of the Maasai tribe of Kenya and Tanzania, along with comparing and contrasting an American coming of age ritual to the rituals of the Maasai tribe. The Maasai tribe has very different expectations and traditions compared American expectations and traditions. Whether that is the fact that in their culture men and women have particular roles and expectations, while America is straying away from stereotypical gender roles and expectations or that in America there are not specific coming of age rituals any one person has to undergo in order to be considered an adult. The Maasai tribe is located in East Africa, more specifically southern Kenya and northern Tanzania. The Maasai people occupy a land area of about 160,000 kilometers. The population being about one half million, although much of the Maasai culture sees the government census as interfering, therefore they miscount their numbers. There are 16 sections: Ildamat, Ilpurko, Ilkee konyokie, Iloitai, Ilkaputiei, Ilkankere, Isiria, Ilmoitanik, Iloodokilani, Iloitokitoki, Ilarusa, Ilmatatapato, Ilwuasinkishu, Kore, Parakuyu, and Ilkisonko, also known as Isikirari, which the Maasai people live in, but the majority of the population lives in the sections that are located in Kenya ( Isikirari, Parakuyu, Kore). The Maasai people mainly use livestock as their source of income, whether it is trading livestock for livestock, cash, beads or livestock products such as milk. TheShow MoreRelatedThe Nilotic Family Of African Tribal Groups1541 Words   |  7 PagesThe Maasai are a ethnic group located in Kenya and northern Tanzania. They are known to be part of the Nilotic family of African tribal groups. 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The word Kenya brings to mind African safaris with elephants, giraffes, lions, tigers, and rhinoceros roaming the Serengeti with the sun setting on the horizon, great running athletes, beautifully carved masks, and ethnic people dressed in bright costumes while engaged in chants and dance to the beat of African drums. It presents itself as picturesque, happy, peaceful, and one can almost hear the music fromRead MoreFemale Genital Mutilation And Women1250 Words   |  5 Pages 1.3 Objectives The aim of this study is to draw light to Female Genital Mutilation in the Maasai community, as well giving insight into the local community’s perspective of the procedure. Furthermore the goal is to look at the steps in which the local community has taken in an attempt to abolish the practice. 1.4 Specific Research Questions What are the roles Female Genital Mutilation plays on the Maasai women? What are the views held by the different members of the community? Men? Women? Parents