Drug safety assessment

Drug safety assessment INTRODUCTION Pre-clinical studies or pre-clinical trials are very important stage of research in drug development process. Pre-clinical trials are also known as non-clinical safety assessment. The main purpose of carrying out these studies is to ensure that the test compound is safe before testing in humans (clinical trials), characterise toxicity and target organs, to fulfil regulatory requirements and to protect employees in manufacturing. In other words, quality, safety and efficacy of a test compound are determined during pre-clinical studies. Animals such as rodents (mice, rat) and non-rodent (monkey, dog) are used in pre-clinical trials before administration to humans (clinical trial phase) so as to separate efficacy from toxicity in human volunteers. The international conferences on harmonisation (ICH) for drug development are regulatory authorities which provide instructions for development and registration of new chemical entities (NCE) likewise instructions for carrying out assessment i n animals. The concept of the 3Rs (Reduction, Refinement and Replacement) is widely employed by ICH for pharmaceutical industries to comply. This concept is employed so as to reduce the numbers of animals and also to avoid prolonged testing period. Anti-arthritis drug are used to treat arthritis (inflammation of joints). Important pre-clinical tests required include general toxicology, safety pharmacology, reproductive toxicology, carcinogenicity studies and genetic toxicology . PRE-CLINICAL TESTS Test for Carcinogenicity Carcinogenicity The carcinogenicity study evaluates the carcinogenic potential of the compound. During pre-clinical studies, animals are used firstly so as to determine the potential risk of the anti-arthritis drug in humans. In order to evaluate carcinogenicity, two types of studies are conducted which are the short-term study and the long-term study. The short-term study involves using the four transgenic models. The four transgenic models used are inactivated tumour suppressor gene (p53+/- model), activated oncogene (Tg.Ac model and rasH2) and inactivated DNA repair gene (XPA-1-model). The genetic alterations of the four transgenic models are made in relation to carcinogenesis processes. The long-term study involves the use of mice or rats of both sexes and is usually a two years study. The correlation between rats to humans is about 70% and is more sensitive making them the major specie of animal used for the long-term carcinogenicity studies. Spragne-daweley has high chances of survival and as a result, these strains of rats are required for the 2years bioassay. Treated animals are divided into three groups each containing about 50-100 animals per sex. In rats, the treated groups are observed for 24months while 18months in mice. Large numbers of animal are used for this study because continuous dosing of the drug could induce tumour and also to achieve a strong statistical result. Furthermore, non-genotoxic carcinogens can cause some rodent strains to be susceptible to tumour induction and in order to distinguish rodent specific processes related to human, understanding carcinogenesis mechanisms based on the specificity of tissues is very vital. Genotoxicity Test Genotoxicity test is carried out so as to determine whether the anti-arthritis drug can cause genetic damage. The genotoxicity test required include; mouse lymphoma assay (MLA) otherwise known as in vitro mammalian cell clastogenecity, the Bruce Ames test (Ames test) and mouse micronuclei assay. These tests detects whether the anti-arthritis can cause alterations in chromosome and damage to DNA leading to genetic mutation and ultimately results in malignant tumour (cancerous cell).The Ames test is commonly used for the genotoxicity test and it detects whether the drug is genotoxic. This occurs by causing back mutation in bacteria colonies and it takes up to about 48hours . Gene mutation, clastogenecity of a genotoxic compound and chromosomal aberrations are determined via the mouse lymphoma assay (MLA) or in vitro mammalian cell clastogenecity. The MLA requires between 2-3weeks and can either give a negative result to the Ames test or not detected at all. An additional test used in g enotoxicity testing is the mouse micronuclei assay which is an in vivo study. This is required because regulatory authorities (ICH) requires both in vitro and in vivo test. The process of ADME of the anti-arthritis drug is used to detect genotoxicity via the mouse micronuclei assay. After performing all the three tests discussed and the anti-arthritis drug remains positive to all, then the drug is probably carcinogenic to humans. Test for Organ Toxicity and Biochemical Dysregulation Safety Pharmacology Safety pharmacology of the anti-arthritis drug is required to detect target organ toxicity such as cardiovascular, central nervous, respiratory, renal and gastrointestinal system. Rodents (such as mice and rats) and non-rodents (such as guinea pigs and dogs) are required or used for safety pharmacology test. Rats or mice are required for CNS and respiratory studies while dog is required for cardiovascular studies. The pharmacological activity of the anti-arthritis drug is determined by carrying out the ligand binding assay which makes in vitro studies preferable to in vivo studies. In safety pharmacology studies, the animals are divided into four groups, three treated group and one control group. The maximum number of rats required per group is fifteen and four dogs group. The duration of dosage in safety pharmacology studies is usually one month . The ICH (S7A) perspective on cardiovascular safety pharmacology required core battery studies and follow up studies. Some of the core bat tery studies include heart rate, electrocardiogram and blood pressure must be evaluated. In vitro and in vivo evaluations, conductance abnormalities including methods for assessing repolarisation must be put into consideration . Some of the follow up studies include vascular resistance, cardiac output, the effects of exogenous and/or endogenous compound on the cardiovascular responses and so on . General Toxicity studies General toxicology test is required for dose determination for No observed effect level (NOEL). The acute toxicity test is also known single dose toxicity and is required to assess biochemical dysregulation and also to determine the levels at which the anti-arthritis drug could cause an adverse reaction. The animals used for general toxicity test are rats and dogs and are usually dosed between 14-28days. Change in organ weight, histopathology, mortality rate, clinical pathology and necropsy are the parameters required to assess toxicity.General toxicology must be done before one month of reproductive studies. Reproductive Toxicity Studies The aim of reproductive toxicity studies is to reveal any effect of the anti-arthritis drug on mammalian reproduction. Rats and rabbits are the most commonly used and widely accepted animal. Rabbits are used because semen is easily collected. The ICH study design for reproductive toxicity studies include fertility and early embryonic development to implantation (rabbits dosed from day 6-18, rats dosed from day 6-15), organogenesis otherwise known as embryo-foetal development and pre and post-natal development (treatment last for 15gestation days and 21lactation days).The study design for fertility and early embryonic development studies requires four groups of 20males and 20females animal. Also, the study design for embryo-foetal development generally have four groups of 20rats or 20rabbits and ICH require evaluation of 16 to 20litters to provide a degree of consistency between studies [8; 9; 12; 13; 14]. Information derived from acute and repeated dose toxicity studies of at least o ne month are required before reproductive toxicology. Conclusion Pre-clinical studies must be carried out before clinical trials so as to protect human volunteers. All the studies described above determine how competent the anti-arthritis drug is before proceeding to clinical trials. All the regulations provided by ICH are widely used most especially the concept of 3Rs. Safety, quality and efficacy are the main objectives for carrying out preclinical studies. Some of the test required during preclinical studies includes carcinogenicity test which involves the short term and long term studies, genotoxicity test, reproductive test, safety pharmacology, renal toxicity test, cardiovascular toxicity test, general toxicity test and neurotoxicity test (functional observation battery test). REFERENCES ICH harmonised tripartite guideline, Dose selection for carcinogenicity studies of pharmaceuticals S1C(R2). Available at: http://www.ema.europa.eu/pdfs/human/ich/038395en.pdf ICH harmonised tripartite guideline, Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals S2A Available at: http://www.bcg-usa.com/regulatory/docs/ich/ICHS2A.pdf ICH harmonised tripartite guideline, Safety pharmacology studies for human pharmaceuticals S7A. Available at: http://www.tga.gov.au/docs/pdf/euguide/ich/053900en.pdf G.B. Jena et al., 2001, Genotoxicity testing, a regulatory requirement for drug discovery and development: impact of ICH guidelines, Indian Journal of Pharmacology. David J. Tweats 1998, Impact of ICH guidelines on genotoxicity testing, PSTT Vol 1, No. 5. ICH harmonised tripartite guideline, Guideline on the need for carcinogenicity studies of pharmaceuticals S1A. Available at: http://www.bcg-usa.com/regulatory/docs/ich/ICHS1A.pdf Guideline for industry, The need for long-term rodent carcinogenicity studies of pharmaceuticals. Availableat: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074911.pdf ICH M3; Timing of pre-clinical studies in relation to clinical trials (see safety topics). Available at: http://www.ich.org/cache/compo/276-254-1.html Preclinical toxicology: Points to consider in programme design. Available at: http://www.pacificbiolabs.com/preclinical James L. Stevens, (2006). Future of toxicology mechanisms of toxicity and drug safety: where do we go from here? Chem. Res. Toxicol., 19, 1393-1401. Yasuo Ohno, (2002). ICH Guidelines-Implementation of the 3Rs: Incorporating Best Scientific Practices into the regulatory Process. Regulatory Testing and Animal Welfare. ILAR Journal V43 Supplement 2002. Lecture notes by Dr Jean-Pierre Valentin, Director Safety Pharmacology, Safety Assessment UK, AstraZeneca. Lecture notes by Dr Lorna M. Burns, Sequani limited, Ledbury, Herefordshire Lecture notes by Dr M. Kelly.

Lord of the Flies by William Golding Essay -- essays research papers

William Golding explores the vulnerability of society in a way that can be read on many different levels. A less detailed look at the book, Lord of the Flies, is a simple fable about boys stranded on an island. Another way to comprehend the book is as a statement about mans inner savage and reverting to a primitive state without societies boundaries. By examining the Lord of the Flies further, it is revealed that many themes portray Golding’s views, including a religious persecution theme. Golding includes the theme of religious persecution to remind people of mans true nature, and by doing so alludes the fact that the next time society deteriorates, due to nuclear war, may be the last. The parallels between Goldings novel and the bible are too numerous for it to be coincidence, which we can see is mainly reflected through characters and symbolism. The first parallel is the similarity between the Garden of Eden and the Island in Lord of the Flies. Both are tropical, beautiful, pristine and untouched. However this changes once the boys have left a scar in the forest of the island, comparable to the scar Adam and Eve left in the Garden of Eden. The most difficult to discover religious element in the novel is the title. Lord of the Flies, once translated into Greek, means ‘Beelzebub’ - a name for the devil. This implies that the embodiment of religious evil is the main thought throughout the book. Another well hidden religious element is the stick sharpened a t both ends, whic...

Thoughts on the Color, Blue Essay -- Exploratory Papers

Thoughts on the Color, Blue During the time when polytheistic religions were widely practiced in Europe, colors represented ideas associated with the paranormal and the spiritual. In many cases, the color blue represented safety and protection. It was believed that if someone wore or carried something blue, the bearer would be protected from evil spirits. Over time, as patriarchal societies formed, the welfare of the male child took priority over the welfare of the female child. Since male children were more important, parents surrounded their sons with blue objects. This explains the common association of males and the color blue that exists even in modern society. A common practice among new families and couples with children on the way is to decorate the rooms of the infants with either blue or pink, depending on the gender of the child. Though some prefer a more neutral tone such as white or beige, blue or pink baby rooms can still be found. This practice promotes the association of the color to the gender and the gender to the color. When thinking of the color blue and ...

Oceans :: essays research papers

Oceans   Ã‚  Ã‚  Ã‚  Ã‚  Earth is the only planet in the Solar System that has liquid water. The ocean contains ninety seven percent of the earth’s water and covers almost three quarters of the planet. There are four different oceans, the Pacific, Atlantic, Indian, and the Arctic. Tides and currents occur in all three of these oceans. Many different kinds of fish and mammals also make their homes in these oceans. All of these oceans are connected to each other in some way. Humans find oceans to be very interesting, beautiful, and exploring. All oceans contain salt water and other minerals. The Pacific Ocean has the largest body of water in it. It spreads nearly halfway around the world. The Pacific Ocean is also the deepest ocean out of all four oceans. The Atlantic contains the second largest body of water. Next is the Indian Ocean, which is on the borderline of being a big ocean and a small ocean. Last is the Arctic Ocean, which by all means is the smallest ocean of them all, and the shallowest.   Ã‚  Ã‚  Ã‚  Ã‚  Tides are common features of the ocean. Tides occur when large bodies water rise and fall, because of the gravitational pull of the moon and the sun. Spring tides are especially strong tides; in spite of the name they have nothing to do with the season spring. They occur when the Earth, the sun, and the moon are in a line. Spring tides occur during the full moon and the new moon. Neap tides are especially weak tides. They occur when the gravitational forces of the moon and the sun are perpendicular to one another. When water moves from side to side, it is called a current. Currents move warm and cold water to different parts of the ocean.   Ã‚  Ã‚  Ã‚  Ã‚  Ocean water is often referred to as salt water. Ocean water becomes salty as water flows in rivers, it picks up small amount of mineral salts form rocks and soil of the riverbeds. This very-slightly salty water flows into the oceans. The water in the oceans only leaves by evaporating, but the salt remains dissolved in the ocean, it does not evaporate. So the remaining water gets saltier and saltier as time goes on.   Ã‚  Ã‚  Ã‚  Ã‚  Animals of the ocean are really interesting and fun to learn about. Many of the oceans fish use what is called a coral as a nursery and a home. This coral also serves as a shelter to the fish from other big creatures that may want to eat them.

Reflective Writing on Marketing Essay

During your time at university you will spend a lot of your time thinking – thinking about what people have said, your reading, your own thinking and how your thinking has changed. The thinking process involves two aspects: reflective thinking and critical thinking. Rather than being two separate processes they are closely connected. (Brookfield 1987) Reflective thinking Reflection is a form of personal response to experiences, situations, events or new information. It is a ‘processing’ phase where thinking and learning take place. There is neither a right nor wrong way of reflective thinking; there are just questions to explore. The reflective thinking process starts with you. Before you can begin to assess the words and ideas of others, you need to pause and identify and examine your own thoughts. This involves revisiting your prior experience and knowledge of the topic you are exploring. It also involves considering how and why you think the way you do. The examination of your beliefs, values, attitudes and assumptions forms the foundation of your understanding. Reflective thinking demands that you recognise that you bring valuable knowledge to every experience. It helps you therefore to recognise and clarify the important connections between what you already know and what you are learning. It is a way of helping you to become an acti ve, aware and critical learner. What is Reflective writing? Reflective writing is: * Your response to experiences, opinions, events or new information * Your response to thoughts and feelings * A way of thinking to explore your learning * An opportunity to gain self-knowledge * A way to achieve clarity and better understanding of what you are learning * A chance to develop and reinforce writing skills * A way of making meaning out of what you study Reflective writing is not: * Just conveying information, instruction or argument * Pure description, though there may be descriptive elements * Straightforward decision or judgement (e.g. about whether something is right or wrong, good or bad) * Simple problem-solving * A summary of unit notes * A standard university essay Why you are asked to do this type of assignment * To make connections The idea behind reflective writing is that what you learn at university builds on your prior knowledge, whether it is formal (education) or informal (gained through experience). Reflective writing helps you develop and clarify the connections between what you already know and what you are learning, between theory and practice and between what you are doing and how and why you do it. * To examine your learning processes Reflective writing encourages you to consider and comment on your learning experiences – not only WHAT you’ve learned, but HOW you did so. * To clarify what you are learning Reflecting helps you to clarify what you have studied, integrate new knowledge with previous knowledge, and identify the questions you have and what you have yet to learn. * To reflect on mistakes and successes Reflecting on mistakes can help you avoid repeating them. At the same time, reflecting on your discoveries helps identify successful principles to use again. * To become an active and aware learner * To become a reflective practitioner once you graduate and begin your professional life How to write reflectively What to discuss * Your perceptions of the course and the content. * Experiences, ideas and observations you have had, and how they relate to the course or topic. * What you found confusing, inspiring, difficult, interesting and why. * Questions you have and conclusions you have drawn. * How you solved a problem, reached a conclusion, found an answer or reached a point of understanding. * Possibilities, speculations, hypotheses or solutions. * Alternative interpretations or different perspectives on what you have read or done in your course. * How new ideas challenge what you already know. * What you need to explore next in terms of thoughts and actions. * Comparisons and connections between what you are learning and: * Your prior knowledge and experience; * Your prior assumptions and preconceptions; * What you know from other courses, units or disciplines. Writing style As it concerns your thoughts, reflective writing is mostly subjective. Therefore, in addition to being reflective and logical, you can be personal, hypothetical, critical and creative. You can comment based on your experience, rather than limiting yourself to academic evidence. * Reflective writing is an activity that includes description (what, when, who) and analysis (how, why, what if). It is an explorative tool often resulting in more questions than answers. * Use full sentences and complete paragraphs. * You can usually use personal pronouns like ‘I’, ‘my’ or ‘we’. * Keep colloquial language to a minimum (e.g. stuff, guys) * A reflective task may allow you to use different modes of writing and language: * Descriptive (outlining how something is or how something was done) * Explanatory (explaining why or how it is like that) * Expressive (I think, I feel, I believe) Tips for your reflective writing process 1. Think of interaction, event or episode you experienced that can be connected to the topic. 2. Describe what happened. 3. What was your role? 4. What feelings and perceptions surround the experience? 5. How would you explain the situation to someone else? 6. What might this experience mean in the context of your course? 7. What other perspectives, theories or concepts could be applied to the situation? References Brookfield, S 1987, Developing critical thinkers: challenging adults to explore alternative ways of thinking and acting, Open University Press, Milton Keynes. Acknowledgement: The preceding material was adapted from The Learning Centre, The University of NSW. Used by permission. Additional notes: Steps for writing a reflective paper: 1.Start your self-reflection paper with an introductory paragraph. This introduction should help set the stage for the reader and should contain the main point of the paper. This would be a good paragraph in which to include information about how the subject and the material impacted your life, whether it reinforced your current views or caused you to change your way of thinking. 2.Write a paragraph or two about the impact the lecturer, classroom/tutorial discussions or the textbook material had on you during the course. Describe emotions you felt you felt or changes you experienced in your personal life due to the topic or the subject. If your opinions on different subjects changed due to these factors be sure to provide your previous opinion and explain why you changed your stance. If your opinions did not change, explain why. 3.Describe a moment during the class that was the most eye-opening for you. One example would be if during a lecture/tutorial the lecturer/tutor used a specific story or analogy to help explain the material that made the lesson really clear for you. Reflect on how you felt when you finally understood the lesson and how that lesson might have impacted the way you think. 4.Write a paragraph explaining how the information from the subject has impacted the way you will think, act and feel in the future long after the semester is over. You may want to include how this subject has changed how you approach other subjects in your degree or life in general. 5.Give feedback in your paper and share your opinions and ideas about how the subject can be improved. Share what you liked about the subject and what material helped you learn the most. Finish the paper by writing a conclusion that summarizes the main points of the paper. This is just one way of structuring reflective writing. Whichever approach to reflection you use try to bear in mind the following key points: * Reflection is an exploration and an explanation of events – not just a description of them. * Genuinely reflective writing often involves ‘revealing’ anxieties, errors and weaknesses, as well as strengths and successes. This is fine (in fact it’s often essential), as long as you show some understanding of possible causes, and explain how you plan to improve. * It is normally necessary to select just the most significant parts of the event or idea on which you are reflecting. If you try to tell ‘the whole story’ you will likely use up your words on description rather than interpretation. * It is often useful to ‘reflect forward’ to the future as well as ‘reflecting back’ on the past. Vocabulary aid (adapted from University of Portsmouth, Dept for Curriculum and Quality Enhancem ent) The following are just a few suggestions for words and phrases that might be useful in reflective writing. Obviously, using these words and phrases will not in itself make you a good reflective writer. 1.Description There is no suggestion of specific vocabulary for any descriptive elements of your reflective writing because the range of possible events, ideas or objects on which you may be reflecting on is so great. However, if you are describing an idea, for example a theory or model, it is usually best to use the present tense e.g. ‘Buyer behaviour theory recognises†¦Ã¢â‚¬â„¢ (not ‘recognised’). Events, of course, are nearly always described in the past tense. 2.Interpretation | | {aspect(s){elements(s){experience(s){issue(s)Idea(s)| Was (were)| For me, the [most]| {meaningful{significant{important{relevant{useful| | | | | learning| {arose from†¦{happened when†¦{resulted from†¦| Previously,}At the time,}At first}Initially,}Subsequently,}Later,}| I| {thought (did not think)†¦{felt (did not feel)†¦{knew (did not know)†¦{noticed (did not notice)†¦{questioned (did not question)†¦{realised (did not realise)†¦| | [Alternatively,][Equally,]| This| {might be{is perhaps{could be{is probably| {because of†¦{due to†¦{explained by†¦{related to†¦| | This| {is similar to†¦{is unlike†¦| because| | [Un]like†¦| this| {reveals†¦{demonstrates†¦| 3.Outcome Having| {read†¦{experienced†¦{applied†¦{discussed†¦{analysed†¦{learned†¦| I now| {feel†¦{think†¦{realise†¦{wonder†¦{question†¦{know†¦| | [Additionally,]}[Furthermore,]}[Most importantly,]}| I have learned that†¦| | I have significantly} slightly}However, I have not [sufficiently]}| {developed{improved| {my skills in†¦{my understanding of†¦{my knowledge of†¦{my ability to†¦| | | This means that†¦This makes me feel†¦| | | This knowledge {isThis understanding {could beThis skill {will be| {essential{important{useful| {to me as a learner [because†¦]{to me as a practitioner [because†¦]| | Because I| {did not†¦{have not yet†¦{am not yet certain about†¦{am not yet confident about†¦{do not yet know†¦{do not yet understand†¦| I will now need to†¦| | | As a next step, I need to†¦| | | More on Reflection What is reflection? A simple definition of reflection can be ‘consciously thinking about and analysing what you are doing and what you have done; thinking about what and how you have learnt. There is a lot of theory behind reflection that can be very complex. Most of the theory relates to seeing reflection as part of the cycle of learning (Figure 1). Initially students focus on knowledge, comprehension and application of subject matter. These three levels of learning are the easiest especially if the application is in a limited context e.g. worded problems from a text book. For higher levels of learning (application of knowledge in real world problems) you must be able to analyse, synthesise and evaluate as shown in Table 1. Reflection is a key part of moving into these higher levels of learning. Figure 1. Leaning cycle and examples of each phase Table 1 Six levels of learning Increasing Difficulty| Process| Explanation| | Knowledge| Recognition and recall of information and facts – describing events| | Comprehension| Interprets, translates or summarises given information – demonstrating understanding of events| | Application| Uses information in a situation different from original learning context -| | Analysis| Separates wholes into parts until relationships are clear – breaks down experiences| | Synthesis| Combines elements to form new entity from the original one – draws on experience and other evidence to suggest new insights| | Evaluation| Involves acts of decision making, or judging based on criteria or rationale – makes judgements about| Why reflect – what are the benefits to the student? Learning is both an active and a reflective process. If you look at the learning cycle in Figure 1 you can see that reflection or thinking about what you have done and how and why you did it, form an integral part of learning. Because learning is often subconscious, we don’t realise that we have gained new knowledge or understanding until we stop to contemplate a particular activity. Reflection then, is a way for critical analysis, problem solving, synthesis of opposing ideas, evaluation, identifying patterns and creating meaning. Reflection will help you reach the higher levels of learning. Most students are focused on the lower levels of learning. â€Å"What do I have to know and demonstrate to pass the exam?† This is a very short-sighted approach to your time at university. You will not be able to remember all the facts and knowledge you have learnt in subjects unless you can fully understand, analyse and evaluate them. As you progress through your degree you will continually need information and knowledge from other subjects and this knowledge will build on previous knowledge. You must be able to attain the higher levels of learning in order to be successful in your degree and later in your professional life. Your learning and the need to learn will not stop with the end of your university degree. Most aspects of learning are common to all disciplines but sometimes there are different emphasises on certain learning skills. For example, generally speaking at university more emphasis is placed on the understanding of the methodology and the processes of problem solving. In this context, reflection will help you to detach yourself from the facts and put them into a larger context. Higher level courses at university as a business student bring a closer interaction between academic work and practical experience. Reflective practice here is critical in providing opportunities to identify areas for improvement and evaluation of the overall outcome including your decision making processes. Reflection can help bridge the gap between theory and practice and will enable you to understand your own thinking and learning. Another benefit is that it encourages you to look beyond your academic accomplishment and recognise the depth and range of other transferable skills. University is more than learning about facts and figures, it is a life experience. You will not learn everything that you need in your professional life at university. Your learning will be life long, so take some time to think about what skills you bring with you to university and what you learn along the way. How do I ‘reflect’? Reflection does not mean that you sit in the lotus position, humming meditative chants. Reflection can be active and need not take away from your ‘study time’. It is an important tool that can be used in all your university and professional work. Opportunities for reflection should occur before, during and after activities. That way you can take note of your learning starting point, assess your progress through the project and critically evaluate your learning at the end of the activity. Look critically at what you have done, what you’re team did and what the outcomes were. You need to ask yourself the why, how and what type of questions. Introducing Reflection Reflection is an important part of your learning whether you do it consciously or not. But what exactly is it? An excellent description of reflection can be found in the Harry Potter novel ‘ The Goblet of Fire’. In the paragraph below Dumbledore, the chief wizard and head teacher, is talking to Harry about having excess thoughts! ‘Harry stared at the stone basin. The contents had returned to their original, silvery white state, swirling and rippling beneath his gaze. â€Å"What is it?† Harry asked shakily. â€Å"This? It is called a Pensieve,† said Dumbledore. â€Å"I sometimes find, and I am sure you know the feeling, that I simply have too many thoughts and memories crammed into my mind.† â€Å"Err,† said Harry who couldn’t truthfully say that he had ever felt anything of the sort. â€Å"At these times† said Dumbledore, indicating the stone basin, â€Å"I use the Penseive. One simply siphons the excess thoughts from one’s mind, pours them into a basin, and examines them at one’s leisure. It becomes easier to spot patterns and links, you understand, when they are in this form.’ (Rowling 2000) During the semester and in your reflective writing we are asking you to think about the process you have been through, how these events affected your behaviour, to think about what you have learnt, and to evaluate your performance. By writing these things down it will give you the opportunity to clarify your thoughts and to spot the patterns and links. Reflective writing examples As an example, look at the following two critiques – one is a better example than the other! [King (2002) Development of Student Skills In Reflective Writing, p 16, http://www.csd.uwa.edu.au/iced2002/publication/Terry_King.pdf ] 1.I woke up late because my alarm didn’t ring. My own fault, but there you are. By the time I had finished my breakfast (my usual bowl of cornflakes, and a cup of black coffee with three sugars), I had missed my bus (that’s the number 9a, picked up at the bus stop outside Halfords), which had left on time (just for a change).So I got to University, and by the time I had found the right room, I was over 30 minutes late for the OOPR2 Exam. Unfortunately, the invigilator wouldn’t let me take the exam because it was â€Å"against University regulations†. Didn’t he realise how important it was for me to pass that exam? My overall grade depends on it, and now I stand to have a resit in September when I wanted to have my holiday in Ibiza.| 2.I was over 30 minutes late for my exam, which meant I was not allowed to sit it. This will have repercussions on my degree mark, and on my holiday plans. This is the first time I have actually missed an exam, but not t he first time I’ve actually been late to exams and important interviews. I have learned that:†¢ I need to improve my time-keeping for critical events†¢ The University has strict rules governing late arrivals at exams†¢ I need to be better preparedThe reasons that I arrived late were:†¢ My alarm clock didn’t ring because I forgot to reset its time after daylight saving on Saturday night (although I had reset all the other clocks in the house).†¢ I totally rely on the alarm clock ringing – I have no back-up system†¢ I rely on my bus – a break down or it leaving early would also cause me to be late†¢ I did not know in which room the exam was; if I had, I would still have been a few minutes late, but at least I could have sat the exam.In order to improve the situation for next year, I plan to:†¢ Have a process to check all the clocks in the house when the clocks are due to change†¢ Make sure I have a back-up alarm system (using my digital watch) for all days when it’s important to get up early†¢ On exam day, aim to catch the earlier bus †¦ its only 20 minutes earlier.†¢ Possibly consider missing breakfast, and buying a sandwich on the way from the bus to the exam room. I do believe that a good breakfast is important though!†¢ Make sure I know the correct room well in advance of the exam, by checking each room number when I first get the timetable.I suspect I need to reflect more on my priorities – this degree is really very important to me.|

The Norton Anthology of African American Literature New York

Booker T. Washington, during the 59 years of his life, rose up from being a slave until the age of nine, to forming a school for African Americans and the education of thousands of African Americans in the pursuit of self sufficiency. Washington has also been deemed as the most famous African American orator and civil rights leader of his time. Coupled with the possession of friendships of very rich and powerful people, sympathetic to the realists’ belief of a self sufficient African American, Booker T. Washington, in addition to his God given ability, is still known and studied to this very day.His influence within the African American community, during his lifetime, as well as even now, cannot be overestimated. In one of the first ways in which Booker T. Washington began to make a name for him was in the construction of the Tuskegee Institute. In 1881, under the recommendation of a number of influential people at the time; Louis Adams and Samuel Armstrong, â€Å"Booker T. b ought the land from what used to be a plantation and began the construction of what would become, perhaps the most famous historically African American college in the country.† The curriculum of the college was representative of the beliefs of Washington. He believed that former slaves and African Americans, who were to follow, would best serve their own interest and the advancement of the race by learning a trade and showing themselves worthy of racial equality in the eyes of the white establishment. This ideology was very different than the more firm and, in the view of most whites, abrasive attitude of W. E. B. Dubois who preached a more aggressive role in civil rights and in the advancement of the Black race.Washington believed that the African American would gain the most for their race, by focusing on learning a trade instead of becoming involved in politics and other, more prestigious careers. The construction of the Tuskegee Institute put into practice, this ideology o f self improvement. In Washington’s most famous works: his autobiography, Up From Slavery, published in 1901, Washington recalled: â€Å"From the very beginning, at Tuskegee, I was determined to have the students do not only the agricultural and domestic work, but to have them erect their own buildings.My plan was to have them, while performing this service, taught the latest and best methods of labor, so that the school would not only get the benefit of their efforts, but the students themselves would be taught to see not only utility in labor, but beauty and dignity; would be taught, in fact, how to lift labor up from mere drudgery and toil, and would learn to love work for its own sake. My plan was not to teach them to work in the old way, but to show them how to make the forces of nature – air, water, steam, electricity, horse-power – assist them in their labor.† In this, Washington was labeled, by some contemporaries as well as future generations, as a defeatist who bowed to the influence of the white establishment. In response, Washington believed that a more realist view of the situation would bring the greatest social and eventual political change. This was at a time when Jim Crow laws in the South were choking any possible ways in which African Americans would be treated as equals. Nearly full segregation in numerous aspects of daily life in the South, reminded African Americans that the country viewed them as second class citizens and inferior to white Americans.Washington, through the completion of the Tuskegee Institute, showed African Americans that self sufficiency could bring more advancement and gain for themselves and their race than anything else at this time. Such views were expressed in Booker T. Washington’s most famous speech. The Atlanta Compromise, given in 1895, spoke these ideals and the prosperity which Washington knew, was within reach for the African American who made himself self sufficient and a s independent as possible.â€Å"There is no defense or security for any of us except in the highest intelligence and development of all. If anywhere there are efforts tending to curtail the fullest growth of the Negro, let these efforts be turned into stimulating, encouraging, and making him the most useful and intelligent citizen. Effort or means so invested will pay a thousand per cent interest. These efforts will be twice blessed—blessing him that gives and him that takes.There is no escape through law of man or God from the inevitable:† Washington, the delight of white Americans and the annoyance of a number of African American leaders during this time, as well as those who would follow in the Civil Rights struggle of the 1950’s and 1960’s, Washington was not a race â€Å"agitator† as many whites would label those who spoke forcefully for social change and equality among white Americans. Not only did Washington attempt to avoid such a label, he also went out of his way to remind African Americans as well as comfort white Americans, that this was not his main objective.â€Å"The wisest among my race understand that the agitation of questions of social equality is the extremist folly, and that progress in the enjoyment of all the privileges that will come to us must be the result of severe and constant struggle rather than of artificial forcing. No race that has anything to contribute to the markets of the world is long in any degree ostracized. It is important and right that all privileges of the law be ours, but it is vastly more important that we be prepared for the exercise of these privileges.The opportunity to earn a dollar in a factory just now is worth infinitely more than the opportunity to spend a dollar in an opera-house. † As a result, Washington was more appreciated within his own community than in generations to come when a more forward policy of racial equality was adopted within the Civil Rights movem ent. Some of the reasons for his success and the ability to afford a speaking tour as well as funding for Tuskegee, were the powerful friendships which Washington was able to form.Some of these notable names of the times were Andrew Carnegie, the $400 million tycoon of the steel industry as well as Henry Rogers and Presidents William Howard Taft and even Theodore Roosevelt who invited Washington to dine with him at the White House; making Washington the first African American to have bestowed upon him, such an honor. The invitation caused outrage within the South and an African American would not have such an honor bestowed upon them for a number of decades, the accomplishment was still achieved.In this, Washington became one of the most successful civil rights leaders of his day. One of the chief reasons why this was the case, above all others, coupled with his God given skill and talent, was the message which Washington repeated over and over in both his speeches and his actions. He was not accommodating to white racism, but was rather a realist who knew that every injustice which stemmed from racial inequality, was not going to be done away with in his lifetime or in the lifetime of his children. Washington was not one to make waves, to complain or to blame whites for his troubles.Many believed that Washington should be doing just that. However, Washington replied by saying: â€Å"There is another class of colored people who make a business of keeping the troubles, the wrongs, and the hardships of the Negro race before the public†¦. There is a certain class of race-problem solvers who do not want the patient to get well, because as long as the disease holds out they have not only an easy means of making a living, but also an easy medium through which to make themselves prominent before the public.† Washington always preached a new, self sufficient African American. Even until his death in 1915, Washington, the most influential leader of the civi l rights movement since Frederick Douglass and still remains as one of the most important in this country’s history, always advocated that African Americans become and remain self sufficient and that they earn the respect from whites which they need in order to achieve the racial, political and social equality which is their uniform goal.When Washington stated: â€Å"One man cannot hold another man down in the ditch without remaining down in the ditch with him. † He meant it. WORKS CITED Perry, John Unshakable Faith Memphis: Multnomah Publishers 2001 Washington, Booker T. Up From Slavery: An Autiobiography New York: Scribners 1980 The Norton Anthology of African American Literature New York: Norton Press. 1999 Booker T. Washington New York: PBS/Thirteen Productions 2001

Heritage Listed Sites- Should It Be Open to Public or Kept Private Essay

Did you know that there are 962 properties listed as heritage sites in the world? As we aware the Kakadu National Park, Uluru, Shark Bay and Great Barrier Reef in Australia are also listed as world heritage sites. However, there are currently 38 properties listed in danger because of various reasons; unable to support with technical, scientific expertise in some areas or â€Å"pollution, uncontrolled urbanization, unchecked tourism† (Amanpour, 2012) in many cases. UNESCO (2013) states that the Tourism impacted on the sites greatly since â€Å"the world heritage properties are among the most popular and heavily promoted tourist destinations in many countries. The dramatic current and projected growth of international and domestic travel represents both challenges and opportunities for World Heritage Sites and surrounding populations. Poorly managed tourism at a site can pose major threats to heritage in all of its forms and degrade the quality of the visitor experience†. For instance, The Great Barrier Reef was declared as a world heritage area in 1981, there have been more than two million people visited the reef each year and generated more than â€Å"$AU2 billion in tourism dollar, making tourism a major earner for the north-eastern Australian economy† and also gave negative impact that damaged fragile corals by reef walking, polluted in the water with human activities not only fuels from boats but associated with †run -off sweat and suntan lotion† affected on the reef environment (Australia Government, 2007). There is a question arose for the heritage listed sites whether it should be open to public or kept private in order to protect and conserve them. It is a controversial topic on the public access to the heritage listed sites; some people may say that the sites should be kept in private in order to protect the area, or some say it should be open to public so it will bring the great benefit to economy. W hile tourism can provide a way to educate the public on the importance of the reef, the constant flow of people over a few select areas of the Great Barrier Reef region can also pose some problems†. A director of Centre of Future Studies believes that â€Å"There is a conflict between environmental concerns and commercial interests† in terms of heritage listed sites (SMH, 2006).It will be discussed the potential benefits and damages for both cases and solutions that can compromise the benefit and the issues. World Heritage Listed Site refers to â€Å"a place (such as a forest, mountain, lake, desert, monument, building, complex, or city) that is listed by the United Nations Educational, Scientific and Cultural Organization ( UNESCO) as of special cultural or physical significance.† as per Wikipedia (2013). There are 190 states parties ratified The World Heritage Convention, as of September 2012, to help these countries with heritage listed sites in terms of maintaining and conserving the sites ( UNESCO, 2013). By all means that a place listed as world heritage site, the place will be supported by UNESCO in relation with protecting and maintaining the sites with well structured plan. W hat is it that makes the sites so important; many countries have formed as ‘rescue team’ to protect the heritage sites? There are a number of reasons as the following: It is our legacy from the past, what we live with today, and what we pass on to future generations. Our cultural and natural heritage is both irreplaceable sources of life and inspiration. Places as unique and diverse as the wilds of East Africa’s Serengeti, the Pyramids of Egypt, the Great Barrier Reef in Australia and the Baroque cathedrals of Latin America make up our world’s heritage (UNESCO, 2013). In addition, the heritage listed sites reflects the way the past lived, thoughts or even the changes geographically over the time in the area which is a great source for researches and studies, the sites also involve the culture of the society. The World Bank defines â€Å"culture as the whole complex of distinctive spiritual, material, intellectual and emotional features that characterize a society or social group. It includes not only arts and letters, but also modes of life, the fundamental rights of the human being, value systems, traditions, and beliefs† (cited on Endresen, p 5). Janet Stephenson, of Dunedin, who is New Zealand historic places trust representative states the importance of the heritage listed sites as â€Å"this is something you don’t get in a museum and †¦ each of these places has heritage role† (cited on Allan, D. The South Times, p19). Also, Australian Government states the importance of heritage listed sites for education, it is important to â€Å"inspire students to explore our unique world heritage listed places and develop an appreciation of heritage values. An understanding of heritage place in Australia and their significance in the world will encourage young people to appreciate and help preserve them for future generation† (Environment Government, 2011). As mentioned earlier, it leaves a big question on how to protect the heritage listed sites, should it be open to public or kept private? There are number of reasons it should open to public. First of all, it can bring great benefits monetarily to local and country as whole, according to Department of Environment and Conservation, Government of Western Australia, it increases wealth of local community, in which the heritage listed site is located, and enable to promote the areas to domestic and international visitors. Harriott states the marine tourism industry is a major contributor to the Australian economy, with an estimated direct value in excess of $1 billion (Wachenfeld et al, 1998 cited 2002, p12). For example, Australian icons such as Uluru , The Great Barrier Reef, and The Tasmanian Wilderness attracted a great number of visitations for both nationally and internationally which was result of heavily featuring in Tourism promotion since the sites listed as world heritage (Shark Bay, 2009). By the booming in Tourism, the area needed more facilities to accommodate the visitors with hotels, restaurants, retail shops and entertainments which created employment opportunity. Producer groups such as construction firms, skilled tradespeople and unskilled workers benefited from extra work created in the heritage sector; also increased local and government income from worker’s tax (Abelson, 2000). Another example –Zhan-gjia-jie National Park, is China’s first national park and also well-known for the ‘Avatar’ Hollywood movie. For this reason, tourism has boomed in the region resulted in generating economic wealth, creation of jobs and development opportunities for local residents. â€Å"Zhan -gjia-jie receives up to 40,000 tourists a day during its high season† (UNWTO, 2011). Secondly, the positive economic impact gained through the profit in Tourism can lead to positive impact on Heritage sites- providing fund for site preservation and management: â€Å"In 1995 the Inter-American Development Bank (IDB) provided a $1.7 million grant to help preserve prehistoric cave paintings at 260 sites within the Capivara Park, a W orld Heritage Site in north-eastern Brazil. The grant included funding to improve roads in order to stimulate tourism as a source of income for local residents, thereby improving economic conditions and helping to reduce activities that were destroying the sites† (cited on Andresen, 1999, p8). Thirdly, â€Å"Visitors to World Heritage sites can learn about natural, cultural and historical characteristics† (Alberta, 2012) . Having a real experience of the heritage listed sites by touching, looking and feeling the existence of the property will be definitely different from learning by photos and story -telling. In spite of the benefits aforementioned, promoting Tourism can negatively impact on the sites itself and the environment due to constructions, pollution and over urbanization. The site will need to accommodate the tourists in hospitality needs; hotels, restaurants and bars, and with other activities to explore that sites, it cannot avoid having a development in the area. There are examples of heritage sites damaged from Tourism such as Angkor Wat which is a temple complex in Cambodia, and the Inca fortress of Machu Picchu in Peru are often cited as places of world-historical importance where a vast influx of tourists may be causing serious damage (The economist, 2012). Also, some researchers clearly demonstrate that The Great Barrier Reef, the world’s largest coral system in Queensland (Wikipedia, 2012), is being damaged (GBRMPA, 2009 cited on Great barrier reef foundation, 2009) and â€Å"lost half of its coral in the past 27years† ( Holland, 2012) by human activities such as fishing, mining, farming and unsorting rubbishes, University of Michigan also states that â€Å"the human based pollution caused such harm to our reefs needs to be stopped or reduced significantly if we wish to save this fragile ecosystem† . In addition there might be unwanted cultural changes, and â€Å"Demonstration Effect† (Endresen, 1999, p8) that comes from exposure to western culture and lifestyle due to tourism, sometimes is blamed for spoiling local culture. According to Endresen (1997, p7) unmanaged tourism can result â€Å"cheapening of culture and traditions; alienation and loss of cultural identity† in the heritage sites. Victoria Falls is the most relevant example in terms of the damages on the heritage listed sites from open to public, led to a various conservation challenges related to urban development, tourism pressure; invasive species; poaching; Water pollution and abstraction; and, institutional challenges (African World Heritage Fund , 2012) which may take up to years to get it recovered. It is critical to get those sites (not only Victoria Falls, but the other 37 sites as mentioned earlier) restored and preserved with our attention and care. On the other hand, if it is being kept private it will enable to reserve the area more efficiently as there isn’t access allowed for public so it can prevent from getting polluted and over-urbanized in the area. Also that helps to preserve damaged areas and get it re-stored as there will not be any restrictions to undergo the repair work. â€Å"The royal tombs, which are registered as UNESCO World Heritage sites, have not allowed public access for the reason of preservation. After going through maintenance and installing several convenience facilities, the tombs ar e now ready to welcome visitors† (visit Korea, 2012). W hat about the potential economic growth in their community or the country by developing the heritage site? The development will attract more tourists who like to visit the heritage sites and trigger increase of GDP through the economic activities made between tourists and locals which will lead to the development of the country as a whole. Various economists state â€Å"the development of tourism has usually been considered a positive contribution to economic growth† (Lim, 1997; Oh, 2005 cited on Chanchrat, 2011, p2). Since it is kept private, there will be forgone cost from not allowing the public access to the site and various parties will lose their potential benefit; the property owner loses in admission fees, local community loses in the benefit from involving active economy in the site area, and the government loses tax income from the sellers and buyers of the economic activity. According to UNICCO it is challengeable to â€Å"manage the future growth of the industry so as to minimise its negative impacts on the environment and host communities whilst maximising the benefits it brings in terms of jobs, wealth and support for local culture and industry, and protection of the built and natural environment† (1999, p21 cited on Endresen, 1999, p2), just like it challenges to keep the heritage sites protected so as to get economic benefit from being open to public. It is obvious that we need to conserve the listed sites at its best by keeping it private but it is, also, impeccable for people at present to get explored of what the ancestors inherited for us, and learn from it to make better future which will be inherited to future generation for our children. It can be protected while the heritage sites being open to public via a number of ways as below: First of all, the industry and the organisation should encourage the public awareness in regards to the importance of the heritage listed sites and the ways that we ca n contribute to protect them. By promoting education for the heritage sites with placing conservation materials at visitor centre will enable to increase public awareness in terms of the importance of those sites. â€Å"Build capacity for cultural management and protection of world heritage cultural asset† â€Å"Promote public awareness of the social value of world heritage sites and the importance of natural resources† (MDGIF, 2012) . For instance there can be TV commercial and donation program promoted by UNESCO just like UNICEF charity program we often see on TV and on airlines that will enable people to aware its importance and for them to practice the good manner when they visit those sites. Also by giving wrist band or badge to people who contributed donation, in recognition of their contribution which will increase the public awareness and helps for the fund needed to support the heritage listed sites. And also managing Heritage listed sites should be well -planned. â€Å"By promoting publicity- developed plan that identifies appropriate levels and types of use and necessary with building environmental awareness, conserving local ecosystem that will result in generating the income and employment for the local communities† (Alberta, 2012) Secondly, Responsible Tourism and Sustainable Tourism should be encouraged.â€Å"You can expect tourist numbers, visitor numbers to grow. And the high level of visitation should not damage the value of the site. So you should have a plan for sustainable tourism in the sites, for all the components† (Bali Daily, 2012). Responsible Tourism refers to tourism that â€Å"makes positive contributions to the conservation of natural and cultur al heritage embracing diversity† and it believes â€Å"individuals, organizations and businesses are asked to take responsibility for their actions and the impacts of their actions† (Wikipedia, 2012). UNESCO states if tourism is undertaken responsibly, â€Å"it can be a driver for the preservation and conservation of cultural and natural heritage and a vehicle for sustainable development† Sustainable Tourism is â€Å"tourism attempting to make as low impact on the environment and local culture as possible, while helping to generate future employment for local people†¦ ensure that development brings a positive experience for local people, tourism companies and the tourists themselves † (Wikipedia, 2013). It also helps â€Å"to meet the needs of the present tourists and host regions while protecting and enhancing opportunity for the future† (World Tourism Organization cited on Pedersen, 2002, p20). Sustainable tourism relies on the development and emphasizes the delivery of quality visitor experiences within not damaging any of the property values or cultural values. According to UNESCO (2013) it requires effective, cooperative commitment and coordination between site management and all relevant public agencies and private enterprises in order to achieve the sustainable and responsible tourism development and visitor management. For example, International Hotel & Restaurant Association (IH &RA) and International Hotels Environment Initiative (IHEI) have helped in raising the public awareness in terms of environmental issues and provided practical advice with Action Pack to assist hotels, and other various industry association have also supported with codes and guidelines that can promote ‘Responsible Tourism’ (Endresen, 1999, p10). Thirdly, establish regulations. Government should establish appropriate regulations and tools to monitor and assess the heritage listed sites consistently in order to maintain them. Under the Environment Protection and Biodiversity Act 1999 (EPBC Act), Governments may require their departments and agencies to have regard for heritage considerations in asset management decisions: Organizations that have control of her itage assets also have a second service obligation. While they use assets in delivering their primary service, they are also responsible for the stewardship of the assets and protection of their significance for future generations †¦ The management of heritage assets should be viewed as an essential part of the management of the assets, rather than another problem and cost impost. Sustainable management of heritage values should be treated by an agency as part of its core business -GAMC, 2003, p13 cited on management of public historic heritage places, 2006, p193). In conclusion, tourism can impact on the heritage listed sites heavily either it damages heritage sites with unmanaged plans, conversely it makes a great contribution on conserving the sites as well as enabling the tradition to be alive from the profits made. It is impeccable that organization; manage any activities in relation to tour operation (travel agencies, airline s and government), should take into accounts in order to conserve the areas in relation to promoting public awareness of environmental issues. The business should be encouraged to design trip-packages that embrace nature resources and culture s. For example, star watch tour; photography tour; camping on the sites; refurbish local old buildings for accommodation; using solar powers and recycling water, composing and sorting the rubbish, to minimize the potential damage to the sites. It can be a good idea to promote rewarding system that allows entry for only certain organizations that practice the sustainability touri sm, to the heritage sites and offer them a cheaper rate of loan for future business. Reference Abelson, P. 2000. 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