The History Of The Liberal Neutrality Politics Essay

The History Of The Liberal Neutrality Politics Essay The question is should all government decisions be made on a neutral basis or is there a point where the government should be able to make a decision that they believe if for the best interest of the individual? This issue is discussed by multiple authors and looked at from different angles. John Stuart Mill discusses his opinion of government authority as it affects an individuals interests in his essay On Liberty. Joseph L. Sax discusses his opinion of government authority as it affects the national parks and individuals different interests within the parks in his book Mountains without Handrails. Both Mill and Sax look at government involvement and decision making in two different ways. One as it applies directly to any interest of an individual and the other as it applies only to an individuals interests in a specific area. The main topic of Mills essay is civil or social liberty. He defines social liberty as the nature and limits of the power which can be legitimately exercised by society over the individual (Mill, 5). Social liberty allows an individual to govern themselves to a certain point. This point is where they potentially could cause harm to others. Once an individual has reached this point, society or the government can step in to prevent harm of another person. Society is neutral in an individuals interests until this point has been reached and they have the authority to interfere with an individuals interest if they deem it harmful to others. This is the idea of the harm principle. Mill says the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others (Mill, 14). In one sense social liberty follows the idea of liberal neutrality but it has a loop hole that allows for some bias decision making by society to protect others. Where society does interfere with an individuals interest it is doing so for the best interest of the rest of society and preventing harm to them. The negative effect of interfering with a single individuals interests is outweighed by protecting one or more individuals from harm that is not necessary for them to endure. All decisions come down to choosing between protecting the interests of an individual or society as a whole. One topic that Mill discusses is the struggle between liberty and authority. Liberty was put in place as means of protection for people from their political rulers. At the time people were born into power and liberty was kind of like a clause if the ruler became a tyrant. Authority is needed to prevent individuals from taking actions that would be morally wrong (causing harm to others). Society then changed and all rulers were no longer born into power, they were chosen to represent the people. The representatives of the people were to represent the best interests of the individuals and this would eliminate the need for some forms of liberty and authority since the people would be need to be protected from their own will. One thing that was over looked was the fact that a single group of representatives cannot accurately represent the entire population, they can only represent the majority and the majority is made up of the individuals who are active in getting their voice heard and does not necessarily represent the entire population. This is the idea of tyranny of the majority. Tyranny of the majority occurs when the majoritys interests are placed above the minoritys interests and causes minorities to be discouraged in getting their opinions heard. This brings society back to the same struggle of liberty and authority and where to draw the line between the two. Individuals want to have the power to so as they please but there should be some guide lines or limits to this power. Mill does not explicitly state what all of these guidelines or limits should be with the exception of causing harm to others. Are more guidelines really needed than that? What is society as a whole just decided to do away with rules, regulations and all types of society authority with the exceptions of something that enforced not doing harm to others and just let an individual decide how they wanted to live their life? This is what libertarians advocate for, liberal neutrality. Having a society with no rules or regulations with only a few minor exceptions, would allow for an individual to focus on their interests and preferences and allow them to achieve their version of the good life since there would be not interferences from society. Having liberties can produce a positive effect in individuals if they are given the opportunity to effectively utilize their liberties. Although Mills essay was published in 1859, the ideas he presents are still currently being discusses such as in Mark Sagoffs Can Environmentalists be Liberals?, Cary Coglianeses Implications of Liberal Neutrality for Environmental Policy and Andrew Vincents Liberalism and the Environment. There is no wrong answer to the struggle between liberty and authority and there is a possibility of multiple right answers for this struggle. Mill discusses liberty in a broad sense, and does not apply it to a specific area of interest but to all areas of interest to an individual. Sax discusses liberty and authority as it directly affects national parks and the individuals who benefit from them. He tries to answer or at least present the different sides of answering the question should the national parks basically be treated as recreational commodities, responding to the demand for development and urban comforts that visitors conventionally bring to them or should they be reserves as temples of nature worship admitting only the faithful? (Sax, 2) Preservationists represent one side of this issue and want national parks to remain undisturbed by human activities. The preference for undisturbed nature and recreation in nature is merely just a matter of taste specific to each individual and no policy will be able to please all parties. One individuals interest and preference for a national park may contradict another individuals interests and preferences, which make it difficult for society to remain neutral n its decision making process. National parks are owned by the public and consist of remote and scenic land in large quantities. Parks were first preserved for the scenery they provided so the average citizen would be able to enjoy them. It was though that the more people who came to the national parks the more support there would be for the future preservation of other parks. People wanted different things from the parks though; some wanted them for sites for picnics and resorts while others wanted them preserved as museums. The parks could potentially provide engagement with nature which provides an opportunity for detachment from the submissiveness, conformity and mass behavior that dogs us in our daily lives; it offers a chance to express distinctiveness and to explore out deeper longings (Sax, 42). The nature within the park has the ability to stimulate reflectiveness and self-understanding. It provides a model of continuity, stability and sustenance, adaption, sustained productivity, diversity and evolutiona ry change. Humans can learn a lot by observing nature and applying it to their lives. If this nature is disturbed then these revelations cannot be observed and applies to other aspects of daily life. The problems of recreation can cause many conflicts in national parks. Recreation can be defined in different ways depending on the individual and can vary from hiking to snowmobiling and from five stat resorts to building your own lean to. A compromise has to be made between the many types of recreation. One possible compromise is to try fully to serve the quantitative demand for conventional recreation and to provide opportunities for all of the different kinds of activities the public wants, but not to assure those opportunities in locations that have a special value for reflective recreation (Sax, 63). There is a demand for different types of recreation including intensive-use activities. A balance has to be determined on what types of recreation can take place where and to what extent do they damage the environment and prevent future usage. Sax described how he believes the national park ought to be. One important note that he makes is to discourage motorized travel within the national parks. He also mentions decreasing crowds and allowing visitors the opportunity to experience the park at their own pace. The problem with some of the ideas that Sax proposes is that there is no easy way to determine how to effectively please each individuals wants from the park. The park service is in a dilemma between too many people wanting to utilize the park and not enough park resources to go around and conflicting interests between multiple parties. Sax recommends dealing with this dilemma by separating the choices that have to be made from each other. This will allow clarity about each decision that is made and how it will impact future decisions made. All decisions made have to bear in mind that the park belongs to all individuals but some forms of activities that consume a lot of the resources for everyone should be avoided so m ore individuals can potential benefit. The parks are there to be utilized by the individuals but individuals attitudes contribute to decisions made directly affect the potential future of the park. A certain level of tolerance is required for all parties to allow for the most effective use of the park and its resources. In Saxs book he looks at the governments role in the preservation of the national parks. The government has the authority to put in place rules and regulations that would limit the activities allowed within the parks. This would interfere with an individuals liberties to make their own decisions to pursue their individual interests and preferences. Saxs opinion is to limit an individuals liberties within national parks and to allow for the government to have the authority to control what happens within the parks. Sax and Mill seem to stand on different sides of liberal neutrality. Mill agrees with liberal neutrality with the exception of causing harm to another individual. Sax disagrees with liberal neutrality and thinks that the government should enforce rules and regulations for the individuals within national parks even if they interfere with an individuals liberties and their versions of the good life. Although Sax is talking about a specific situation were liberty and authority conflict, it can be assumed that Mills argument applies to all aspects of an individuals life including national parks. Assuming both Mill and Sax are focused on national parks and an individuals liberties within the park they are really not all that different. Mill and Sax both want individuals to be able to pursue their interests and preferences within national parks. Mill allows for these interests and preferences to be followed until they will cause direct harm to another individual. Sax allows for these interests and preferences to be followed until they will cause direst harm to the environment and potentially cause indirect harm to other individuals trying to utilize the national parks resources. Sax allows an individual to govern themselves to a certain point and his point is where an individuals actions will potentially cause harm to the environment. Causing harm to the environment will limit the availability of current and future park resources for other individuals to enjoy and could harm them and not allow them to pursue their interest and preferences within the national park. In this sense preservationists and environmentalists are liberals and allow people to do as they please without interference form society until they reach the point of harm. The idea of liberal neutrality centers around being open to different individuals version of the good life and being neutral in the decision making process that will affect an individuals ability to achieve their version of the good life. Mills essay he defines liberty and discusses limiting the authority society has over the individual/ Saxs book focuses more on allowing society to have the authority to interfere with individuals liberties as they pertain to the national parks. Both Mill and Sax present different points about the struggle between liberty and authority, they both agree on the authority to interfere with an individual if they are going to cause harm to something else. Mills version of harm focuses on harm to other individuals while Saxs versions of harm focuses on harm to the environment which is a public good and could cause harm to others if not looked out for.

Does Coriolanus make mistakes or errors in judgement that lead to his downfall? Essay

Does Coriolanus make mistakes or errors in judgement that lead to his downfall? If so, what are they and how did they lead to his downfall? The play Coriolanus concerns the downfall and eventual death of a Roman general turned politician, Cauis Martius (later given the name Coriolanus after conquering the city of Corioles). Equipped with the traits of a brave soldier, a short temper and arrogance, these characteristics aid in his downfall which was also aided by several other factors. Whether it be a mistake or an error in judgement on Coriolanus’s side, it is the result of either one which causes trouble for him. After announcing that he is reluctantly joining the senate, his mistakes and errors in judgement along with the rest of him would be publicly scrutinised, questioned and judged before the public. He lost the advantage of making mistakes and errors in judgement in the course of war where they would most probably end in his own death or personal injury. Additionally they would be looked at as victory scars or and as a mark of heroism rather than a result of a foolish and rash decision.It comes down to the fact that he would not have to answer for his mistakes in war as opposed to his mistakes against the plebeians who are not particularly fond of him. Coriolanus, though he is brave, ferocious and strategic in the context of war where the consequences of miscarried and miscalculated actions do not bring great effect, he is helplessly out of his element when his mother Volumnia coerces him into politics. ‘I have lived to see inherited my very wishes†¦. only there’s one thing wanting,†¦.but which our Rome will cast upon thee.’. Running for consulship was clearly a mistake, because firstly, he has no desire for it, ‘Though he obeys his mother’s wishes and dons the gown of humility. It is clear through his thinly veiled contempt for the people he is unsuited as he regards them as ‘hares, geese’, unworthy animals. Wholly unsuited for a career in politics due to his arrogance, brutal honesty, tactless manner and moreover his inability to conceal his true self and to pretend to care for the well being of the plebeians, Coriolanus himself said so, ‘Would you have me false to my nature, Rather say I play the man I am,’ Though he stands for himself, his own idea backfired and it resulted in his banishment. To call Coriolanus obeying his mothers orders a mistake would be inaccurate as he is predisposed and psychologically unable to refuse her demands. It is fair to say that Coriolanus relentlessly seeking for her approbation aids in his downfall. Going against his wishes to satisfy her wish for him to fight for his place in the consul by humiliating himself further; apologising to the plebeians. She, (Volumnia) says to Coriolanus, ‘To beg of thee is more my dishonour than thou of them†¦Ã¢â‚¬â„¢. She gives up and plays the role of the disappointed mother and Coriolanus caves in. ‘Prithee mother, pray be content†¦ chide me no more†¦Ã¢â‚¬â„¢ Though he would certainly be aware that listening to his mother was a mistake if her were not so dependent on her approbations and love. Though not a clear cut mistake, it certainly aided in his downfall. Coriolanus certainly obtains some time away from the influences of people when he is banished. He arrives at Antium, where he is prepared to die at Aufidius hands for all the harm he has done, ‘If he slay me, He does fair justice†¦Ã¢â‚¬â„¢. Though he goes on to say, ‘if he give me way, I’ll do his country service.’ he switches his allegiances to Aufidius. This was an independent decision where he was influenced by his country’s hatred for him and it lead him to serve another country whose wish is to destroy his home. This portrays Coriolanus as a vengeful, hateful and hyper aggressive as his first task is to seek revenge by destroying Rome, the city who did not fully appreciate their hero. This is not entirely a mistake as he would have gone through with his plan if not for him obeying and pleasing his mothers wishes which often carry dangerous consequences. This was more of an error in judgment as he depended on his dejection, rejection and anger to govern his decision to join Aufidius in order to be against Rome. He fails to see his tether to Rome; his family and to a certain degree, his father figure, Menenius. At their profuse begging for mercy upon Rome he complies but at the cost of his life. The fatal ending of his life stems from his being independent in deciding to fight Rome but his tether to it prevent him from his plan of joining Aufidius and being a great soldier. It also leads him to a death as a traitor at the hands of his jealous ally who was playing second fiddle to Coriolanus. It further reminds Aufidius of his losing to Coriolanus and this has placed him in the line between ally and enemy, one of his officers even say, ‘And you darkened in this action sir. Even by your own;’ By being the great soldier he is he has subtly wounded the ego of his ally who is second to him as a soldier and a leader. He was unaware of Aufidius’s wounded pride after beating him in battle, 5 times. The signing of the peace treaty with Rome pushed him into being a traitor in Aufidius eyes and those of Antium. After a heated verbal confrontation between Coriolanus, Aufidius and his conspirators, Coriolanus is killed. It is fair to say that Coriolanus’s actions affect the most influential people in his life, and events. His being a good obedient son to a domineering, persuasive mother lead him to the event that highlights his flaws as his primary characteristics; the event being running for consulship. His inability and refusal to veil his hatred for the plebeians who are so easily influenced lead to his banishment. In the end, in him ‘playing the man am I am’ a great soldier, prompted envious and jealous feelings in his ally who later did not need much to kill him. Coriolanus’s mistakes and errors in judgment were all leading to his eventual death due to him being governed by negative people, like his mother. Also negative emotions; his arrogance, and pride which refused and was unable to control due to his nature of seeking pleasure in violence, anger and was in full accordance of his warped upbringing by his war-hungry mother who has only projected maternal sense.

Finding the Best Ap 5 Essay Samples

Finding the Best Ap 5 Essay Samples Attempt to select the best devices to strengthen your argument that you're able to. You could look at providing specific instances or examples from inside the case study to back up your response. You need to place your ID whenever you access the system, and utilize it when you want to restore a forgotten password. You should work on recognizing what constitutes historical context based on the AP. Perhaps the most essential consideration to remember in writing essay exams is you have a limited quantity of time and space to get upon the knowledge you've acquired and your capacity to utilize it. Not just you get to get a superior grade, in the grueling procedure, you also learned some new understanding. Teachers typically request particular kinds of references and citation accuracy is essential to prevent plagiarism. The student forces the reader to create the connections. Essay exams are a beneficial tool for finding out if you may sort through a massive body of information, figure out what's essential, and explain why it's vital. Finally, I've provided some tips on how best to best use sample essays in your preparation procedure. Inside this section you'll find samples of essays belonging to different essay types and manners of formatting. Be certain to have a look at this article for tips and samples for each one of the Common Application essay choices. You should make a strong well-supported analysis instead. It says you ought to not do an overview of the whole plot. You will discover structure of the way the report ought to be. This results in the population to decline. Imagine yourself being an attorney who needs to argue a case in front of a skeptic jury. The very first portion of the question is going to be a statement. This question was reworded for 2017-18, and the present language is an immense improvement. Knowing the question you're answering is the most crucial portion of AP writing. In the event the answer is yes, attempt to structure your argument in order for your points build off one another. These answers have to be based from your own viewpoint, not others. The solution to this question is dependent on your study plans! College Board sample essay sets are a terrific means to test how well you comprehend the rubric. Note you do not need to have solved the issue, and a few of the greatest essays will explore problems which should be solved later on. There are over a dozen varieties of essays, therefore it's easy to become confused. You might be asked to compose an NHS essay before joining to demonstrate that you're eligible to join a prestigious organization. Take all the time you've been allotted. To join our classes it is possible to make payment online. Some students think about the absolutely free response section being the hardest portion of the whole English exa m. Consider your time again. The exam is almost always a difficult situation to cope with. If you're stuck in circumstances like this, you want to get familiar with DBQ before your exams will happen. You'll observe a similar structure in a lot of the essays. This kind of essay wants a good framework and great support. Now that you're acquainted with writing a DBQ essay, it wouldn't be too challenging in your part to compose an excellent and robust essay to land yourself a great grade. These seven sample essays respond to a range of thought-provoking questions. There is only one difference within this prompt, and it lies within this synthesis essay you should write. Thus, you wouldn't locate the practice of writing a contrast essay extremely demanding. The finest persuasive short essays often concentrate on controversial problems. There is a particular essay in the prompt that you should analyze. Vital Pieces of Ap 5 Essay Samples The second point, that making connections is a kind of thinking which can be taught, can't be proven until the very first point has been sufficiently supported. The tips which I am receiving from him now are things that I haven't ever heard from anyone before. Go at your own pace, and you will observe your timid forays into academic writing start acquiring an expert touch. You should be ready to work hard from the beginning.

The Freedom Of Speech - 833 Words

â€Å"What you are doing takes a lot of courage†¦ There are already plenty of people fighting fire with fire, and it’s just not helping anyone or anything. So I’m just going to keep listening, with an open mind†; said Nate Boyer in a letter to Colin Kaepernick. In 2016 when Colin Kaepernick sat during the National Anthem to protest police brutality towards African Americans. In response some people were angry but Nate Boyer, a former Green Beret, wrote him a letter. In the letter he states that his initial reaction was one of anger but after looking at Kaepernick’s point of view he respects his opinion and supports his first amendment right. Kaepernick then invites Nate Boyer to join him on the sidelines for a game. Before the game the two come†¦show more content†¦In recent years people have overall become more aggressive with their opinion and more often have a â€Å"my opinion has to be correct† attitude. People are often arguing ab out political and nonpartisan issues alike when they could be having a discussion. Each person who argues tends to be ignorant to what the other has to say. We hold being right over respecting what the other thinks and has to say. Good listening skills tend to elude modern day arguments. The purpose of having a decision is not to win an argument but to get your point across and gain insight. When you’re listening instead of being defensive about your opinion you will learn a lot more. When Boyer writes a letter to Kaepernick he shows that he respectfully hears and is trying to understand Kaepernick’s point of view. He admits that initially he was a bit angry though after taking a moment to reflect on his personal experiences he’s able to empathize with Kaepernick. Boyer is setting a quality example for everyone to take note of. Kaepernick is protesting the police brutality against African Americans. There have been multiple cases in which a white policemen have shot and killed an African American for little to no reason. He’s peacefully protesting along with those who’re a part of the Black Lives Matter movement. They’re seeking to inflict change with peaceful protests. By kneeling during the national anthem Kaepernick kneels for his fallen comrades. He’s not negativelyShow MoreRelatedFreedom : Freedom Of Speech And Freedom Of Speech1167 Words   |  5 Pagesdetermining how much freedom the citizens in a society has. Throughout history we have seen many different type of governments that include North Koreas’ dictatorship to the United States that has a government based on principles of democracy. In societies that have democratic governments such as the United States, England, France, and many other western European countries, the citizens have a high degree of freedom o f speech. In addition, these people are allowed to have a high degree of freedom of thoughtRead MoreFreedom Of Speech : The Freedoms Of Freedom Of Speech937 Words   |  4 PagesFreedom of speech now a day’s means being able to have the right to express one’s own opinions without restraint. The United States of America is an open country for any U.S. citizen to be free to say what one would like. By citizens having freedom of speech, it gives the people the right to use hate speech. Freedom of speech belongs to every person in the United States. Here lately citizens are witnessing the rising concerns with hate speech. Unfortunately, hate speech is protected by freedomRead MoreFreedom And Freedom Of Speech Essay2518 Words   |  11 Pages Many people come to the United States looking for freedom and liberty and where their essential rights are protected under the Constitution. However, freedom should not be taken for granted as for every rule there may be limits. The First Amendment of the United States’ Constitution states that â€Å"Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably toRead MoreThe Freedom Of Hate Speech Is Not Freedom Speech1143 Words   |  5 PagesHate Speech is not Freedom Speech Between August 11th and August 12th of 2017, the world watched the disturbance news of what was going on in Charlottesville, Virginia. The horrific videos and images left the world in shock. Groups of white supremacy, nationalists, hitler youths marched in unison screaming, â€Å"White lives matter! Blood and Soils! You will not replace us! Jews will not replace us!† More groups enraged their voices across Virginia to scream hate speech to other races. They threatenedRead MoreSpeech : Freedom Of Speech1364 Words   |  6 Pages Even though freedom of speech can be tricky, understanding what can be said under the first amendment is key. This will give you more confidence when you re talking about current events, it ll inhibit social interaction, but the biggest reason of all is understanding your rights will keep you out of jail. Even the supreme court struggles to determine what exactly constitutes protected speech. When trying to see if your covered by the first amendme nt, certain questions have to be displayed. AreRead MoreFreedom Of Speech : The Importance Of The Freedom Of Speech1039 Words   |  5 PagesFreedom of speech is a right protected by the First Amendment. According to the administrative office of the United States Courts (n.d.), the First Amendment states that, â€Å"Congress shall make no law... abridging freedom of speech.† Freedom of speech is arguably one of the most cherished American values in the First Amendment. As defined by an online unabridged Dictionary (n.d.), The rights covered by freedom of speech include the right to express opinions publicly without governmental interferenceRead MoreSpeech On Freedom Of Speech953 Words   |  4 PagesFreedom of speech is authorized to every person; rich or poor, young or old, every person holds different opinion and it’s their right to express it. The definition of Freedom of speech is, every person has the right to express his/her opinion without the fear of governme nt or society telling them it is wrong to express. Being individuals, we are all different. We all possess different ideas, tastes and thinking. Freedom of speech is like freedom of thoughts. If we are comfortable with each other’sRead MoreFreedom Of Speech : The Power Of Freedom Of Speech1860 Words   |  8 Pages Freedom of speech would be easy if words did not have power. Guaranteeing people, the right to say and print whatever they wanted would be easy if we could believe that words had no real effect. But unfortunately, Americans tend to believe that words do have power and that they can anger and inspire, cause people to rise up and act out in harmful ways. Americans celebrate speakers like James Otis, Abraham Lincoln, and Martin Luther King, Jr., whose words inspired people to fight for independenceRead MoreSpeech On Freedom Of Speech1484 Words   |  6 Pages Abby Koopmann Ethics Freedom of Speech Professor Hunt Culver Stockton College Freedom of Speech Americans have many freedoms that people in other countries can only wish they had. Just imagine a life where you could possibly be killed for speaking your mind and stating your opinion, other countries are living lives like that. According to Katy Davis, The United States ratified the first amendment on December 15th 1791 (Davis, n.d). We as a country don’t know where the governmentRead MoreFreedom Of Speech : Speech1105 Words   |  5 Pages Freedom of Speech Freedom of Speech, part of the First Amendment, is a privileged right that should not be taken lightly. The Milo Bill is said to protect students’ right to their freedom of speech on school grounds. It was introduced at Tennessee’s State House and is named after Milo Yiannopoulos, a British public speaker who made a career out of â€Å"trolling† liberals and gained publicity for uncalled-for acts, such as racist and harassing comments on Twitter, which got him banned from the social

North-South Divide - 1613 Words

The North-South Divide (or Rich-Poor Divide[citation needed]) is a socio-economic and political division that exists between the wealthy developed countries, known collectively as the North, and the poorer developing countries (least developed countries), or the South.[1] Although most nations comprising the North are in fact located in the Northern Hemisphere (with the notable exceptions of Australia and New Zealand), the divide is not wholly defined by geography. The North is home to four out of five permanent members of the United Nations Security Council and all members of the G8. The North mostly covers the West and the First World, with much of the Second World. The expression North-South divide is still in common use, but†¦show more content†¦On an ideological level, some development geographers have argued that current concentration on the North-South divide as the main organizing principle for understanding the world economy has overlooked the role of inter-imperial conflicts between the United States, Japan, and Europe.[5]. [edit]Defining development Being categorized as part of the â€Å"North† implies development as opposed to belonging to the â€Å"South† which implies a lack thereof. The north becomes synonymous with economic development and industrialization while the South represents the previously colonized countries which are in need of help in the form of international aid agendas [6] In order to understand how this divide occurs, a definition of â€Å"development† itself is needed. The Dictionary of Human Geography defines development as â€Å"[p]rocesses of social change or [a change] to class and state projects to transform national economies.[7] This definition entails an understanding of economic development which is imperative when trying to understand the north-south divide. Economic Development is a measure of progress in a specific economy. It refers to advancements in technology, a transition from an economy based largely on agriculture to one based on industry and an improvement in living standards.[8][9] Other factors that are included in the conceptualization of what a developed country is include life expectancy and theShow MoreRelatedThe Global North/South Divide1724 Words   |  7 PagesA descriptive essay on the Globla North/South divide. Explores the social, cuptural and economic differences that exist between the regions defined as the global north and the global south. The theory of the Global North and Global South is a new geopolitical perspective. It divides the world into two blocs – the industrialized countries of the global North and the poor countries of the South on the global level of analysis. While â€Å"Global South† is sometimes used as a synonym for the more familiarRead More Antebellum Slavery: The Great North-South Divide781 Words   |  4 Pagesperiod began, the American Nation was divided into the North and South by many issues but most economic issues arising from western expansion and slavery. While the North had abolished slavery, the South insisted on slavery for the cultivation of their cash crops especially cotton. The south had religious and racial justifications for the institution of slavery and even went so far as to proclaim slavery was for the slave’s own benefit. The North, motivated by the second Great Awakening however, hadRead MoreCritical Analysis Of The North South Divide In Italy1702 Words   |  7 PagesThey begin to show the deficits of the system by introducing the North-South Divide in Italy, wherein those who live in the south of the country tended to be less positive about the state of their country and their regional syste m. This was true in discussions about public satisfaction, and from councillors themselves where in the north was consistently more optimistic about the state of the regional system, even though all preferred the regional system to the former national one. Though talks aboutRead MoreHow Did the Indsutrial Development Unite or Divide the North and the South?1434 Words   |  6 Pagesindustrial and technological development. Both the North and the South created many advances in railroad and water transportation. The Union, however, was far more advanced technologically than the Confederate states . Consequently, the North made greater and more effective use of progress in weapons, communication, transportation and medicine than South . Although the industrial development made the nation very widely known, both the south and the north were divided because their differences. The CivilRead MoreThe Election Of 1848 And Emerging Sectional Divide Between The North And The South Over The Issue Of Slavery1708 Words   |  7 PagesSemester Long Research Paper The election of 1848 revealed and emerging sectional divide between the north and the south over the issue of slavery. The was the 16th presidential election held on November 7, 1848. Zachary Taylor, who was a member of the Whig party won over Martin Van Buren of the free soil party. Slavery was defined as a legal or economic system in which principles of property law were applied to humans allowing them to be classified as property, to be owned, bought and sold accordinglyRead MoreSummary of Industrial Convergence, Globalization, and the Persistence of the North-South Divide by Arrighi, G,. Silver, J, B,. and Brewer, D, B,. (2003)1418 Words   |  6 Pagesthe Persistence of the North-South Divide. Studies in Comparative International Development. p.3-31 Through the use of descriptive and comparative analysis, the authors intend on demonstrating that the convergence of the industrialization gap was not accompanied by a convergence in the income levels gap between former First World and Third World countries. Thus, the North-South divide still exists. Through economic models, the persistence of the North-South income divide is explained. SimultaneouslyRead MoreThe Global Divide Essay1465 Words   |  6 Pagesread further, you will see how globalization and the north- south global divide play a key role in our nation’s economy. From the wars on European soil and increasing poverty in Africa, to the booming technological abilities in Japan, this one word will be an understatement to all things to come. I’ll explain how the global divide started and how globalization plays a key role in the world’s own destructive nature. As the gap between the two divides grows further and further apart, the one questionRead MoreTh e Annexation Of Texas And The United States928 Words   |  4 Pagesshould be done with the new found territory. Whether it was people of the north looking to prevent another slave state from acquiring statehood, or slave owning people of the south trying to gain leverage in the House of Representatives, people had differing opinions on the topic of Texas. The debate over Texas acquiring statehood was representative of the divide between North and South that led to Civil War in the U.S. In the North, many people didn’t want Texas to become a state, therefore were againstRead MoreThe United States Essay1243 Words   |  5 PagesOcean. This time period would become known as Manifest Destiny. Over the five decades that Manifest Destiny lasted politics and the government changed along with the geographic face of the United States while the country expand to cover most of North America. Of these political changes, the death of the Federalists, birth of the Whigs and reformation of the Democratic party were among the most prominent. However an underlying conflict began to progress with each new purchase and acquisition ofRead MoreCauses Of The Civil War1740 Words   |  7 Pagesconflicts kept creating a divide amongst the states in the nation. The divide finally became so great, that the United States split into the Confederacy (South) and the Union (North), and fighting erupted. â€Å" â€Å"The Civil War,† Randall Jimerson observes, â€Å"became a to tal war involving the entire population precisely because both sides fought for ideological principles. Compromise and surrender were unthinkable when so much was at stake.† †(Finseth, 16). The root of the cause for the divide was slavery, but there

Investigational New Drug Review Process Free Essays

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 Sponsor 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. We will write a custom essay sample on Investigational New Drug Review Process or any similar topic only for you Order Now 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 studies B. 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 product. 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 These 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 clinical 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. Toxicology 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 How to cite Investigational New Drug Review Process, Essays

Bordetella Pertussis free essay sample

In 1906 two Belgian bacteriologists, Jules Bordet and Octave Gengou first discovered Bordetella pertussis, what is known today as the whooping cough, by isolating it in pure culture. They distinguished the whopping cough agent from the respiratory tract of children (Jules Bordet). B. pertussis is a very small, prokaryotic, coccoid bacterium, which does not make endospores. It is a gram negative bacterium which means the cell structure contains an outer membrane, an inner membrane, and a thin peptidoglycan layer. It metabolizes through aerobic respiration, is nonmotile and an encapsulated microorganism. It appears either in pairs or singly, cannot survive in the environment and only reside in human hosts, where it usually appears in the trachea and the bronchi. B. pertussis produces several virulence factors. These include pertussis toxin, which is secreted in the cell and extracellular fluid, and filamentous hemagglutinin, which is a â€Å"fimbrial-like structure on the bacterial surface† (Todar). B. pertussis is nutritionally fastidious meaning it has complex growing requirements, and is difficult to grow without specialized media. We will write a custom essay sample on Bordetella Pertussis or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page It requires special growth factors and may not grow on routine media, although it has been found that the organism grows better on a media that has a slightly acidic pH. Growth of this organism is restrained by its own waste as well as heavy metals, peroxides, sulfides, and fatty acids. To neutralize any inhibitory substances and absorb toxic metabolites this organism is often grown on media with rich concentrations of blood, or charcoal. (Pertussis. ). Two different solid cultures that are used in growing B. pertussis are Bordet-Gengou agar (BGA) and Regan-Lowe agar (RLA). Bordet- Gengou agar contains potato starch and is peptone free, also an inhibitory substance. It also contains glycerol as a stabilizer, and an antibiotic, such as penicillin, to restrain gram positive organisms from growing, although the antibiotic may slightly restrain B. pertussis itself. Another method of growing B. pertussis is on Regan-Lowe agar. This agar is a charcoal based solid with defibrinated horse blood. (Ahmad). The charcoal helps absorb waste products and toxins. This charcoal agar has become more popular in laboratories because, â€Å"of the ease of its preparation and its superiority in growing B. ertussis by absorbing the toxic metabolites of the organism† (Ahmad 1071). B. pertussis grows quite slowly and it best grows when it is incubated at 35 ° to 37 ° C in a humid or moist environment for about 3 to 6 days. It grows as a mercury colored droplets with domed colonies. B. pertussis is a worldwide occurrence that causes a highly contagious acute infectio us disease called â€Å"whooping cough† which resides in the upper air pathways such as the bronchi and trachea, and appears on epithelial cilia of respiratory tract. A â€Å"whoop† is a â€Å"high-pitched noise heard when breathing in after a coughing spasm† (CDC). The first outbreaks were described in the 16th century but it was not until 1906 that it was discovered. it is a much more milder disease in adults than it is in infants, in which it can be very severe and frequent, and it was not until the 1930’s that immunization was discovered. B. pertussis is contracted through aerosol droplets from person to person, which are either sneezed or coughed in the air by the infected person. The bacteria then â€Å"attaches to the cilia of the respiratory epithelial cells, produce toxins that paralyze the cilia, and cause inflammation of the respiratory tract, which interferes with the clearing of pulmonary secretions† (Pertussis). After seven to ten days of the incubation period of the bacteria the first stage of the infection appears. This stage lasts anywhere from one to two weeks and is called the catarrhal phase. In this phase the infected person experiences cold like symptoms such as runny nose, fever, mild cough, and sneezing. After about another week or so the cough slowly becomes more severe and the second phase of the disease presumes: the paroxysmal phase. Only during this phase can the diagnosis of whooping cough actually be claimed. The cough appears at various intervals where one may become cyanotic, turn blue, and may result in vomiting due to mucus buildup on the tracheobronchial tree. If the cough is long enough an infant may go into hypoxia, which is a state where there is a reduced amount of oxygen, and further lead to seizure. In result other symptoms include dehydration, weight loss, and potentially anorexia. The last phase is called the convalescent phase meaning gradual recovery phase. The cough becomes less severe and disappears within a few weeks. (Pertussis ). â€Å"In 2004 through 2008 a total of 111 deaths from pertussis were reported to the CDC†. ( Pertussis). Pertussis toxin is an exotoxin that is produced during the infection and is the major cause of the abnormal cough. It causes T cell lymphocytosis, increased IgE synthesis, hyperglycemia, increased endotoxin sensitivity, and impairs NK cell killing. This results in the accumulation of large amounts of cAMP which leads to increased mucus secretion and interferes with many cellular functions† (Ghaffer). Other virulence factors include filamentous hemagglutinin, pertactin, and fimbriae. These are adhesions that allow the bacterium to attach to the glycolipids on the membrane of ciliated epithelial cells of the respiratory cells. (CD C). Precautions to take in order to prevent pertussis are getting vaccinated, as early as 6 weeks old, with the diphtheria-tetanus-pertussis vaccine, good hygiene, and covering the mouth when sneezing or coughing. Antibiotics are used to treat the disease. In 2010, 27,550 cases of whooping cough in the United States have been reported to the CDC. Worldwide there are up to 50 million cases and over 300,000 deaths that have been reported. Whooping cough may not sound like a severe disease but if people go untreated and unvaccinated, especially people in less developed countries, it could become fatal, especially to infants and younger children, whose immune systems are not as strong. Therefore, it is important that as many people are aware of this disease and do not go unvaccinated or untreated.