The social cultural impacts of the Montserrat Volcanic Crisis placing the experience in a wider Caribbean context Essay Example

The social cultural impacts of the Montserrat Volcanic Crisis placing the experience in a wider Caribbean context Essay Montserrat is a small Caribbean island of approximately 102km2 in size and is situated to the South of its closest neighbour, Antigua. Both islands form part of the Leeward Islands chain as shown below: The island itself is a British overseas territory of volcanic origin, and until recently remained dormant. However, since 1995, the island has been severely affected by eruptions of the Soufriere Hills Volcano and the subsequent pyroclastic flows and mudslides associated with the volcanic activity. Such events have destroyed Plymouth, the Islands capital, the Airport situated on the East coast and much of the Southern third of the island. We will write a custom essay sample on The social cultural impacts of the Montserrat Volcanic Crisis placing the experience in a wider Caribbean context specifically for you for only $16.38 $13.9/page Order now We will write a custom essay sample on The social cultural impacts of the Montserrat Volcanic Crisis placing the experience in a wider Caribbean context specifically for you FOR ONLY $16.38 $13.9/page Hire Writer We will write a custom essay sample on The social cultural impacts of the Montserrat Volcanic Crisis placing the experience in a wider Caribbean context specifically for you FOR ONLY $16.38 $13.9/page Hire Writer This has resulted in considerable social implications as a consequence of de-territorialization defined by Rozdilsky (2002) as the process of losing the natural relationship between culture and social territory, including the old new forms of symbolic production. The island once had a population of over 11000 people, which decreased considerably by approximately 2/3 to just 4500 in 2000 and is now home to only 80% of the original population figure approximately 8 000 people. In response to the eruption, approximately 2500 people relocated to other Caribbean islands and 3300-3700 had relocated before 1998 (DFID, 1999). Currently, the population is concentrated into the Northern third of the Island following the introduction of an Exclusion Zone encapsulating the most dangerous areas surrounding the Soufriere hills as shown below: The evacuation of people from dangerous areas of the island caused localized unrest and placed enormous pressures on the islanders. As Shotte describes the effect of these movements: Life for Montserratians has never been the same since July 1995. Three phases of internal displacement within the first nine months of the volcanic crisis, proved to be a frustrating and emotionally draining experience. Thus began the roller-coaster existence of a people whose lives were forcefully propelled on to unexpected and challenging roadways. The considerable reduction in land available for housing created serious social impacts; Those who chose not to leave the island following evacuation from the South where faced by two possibilities share with friends/family or be placed in temporary accommodation such as the Montserratian Defence Force barracks at Geralds. Eventually 1 in 7 people were housed temporarily in shelters. For many, a sense of order and stability in life is represented by land and home. For many Montserratians, this has been removed, producing disassociation and a confusion as to the sense of belonging. The people of Montserrat pre-1995 had a particular emotional attachment to their land. Plymouth and other areas around the island not only symbolised their identity and sense of being but also their ancestors struggle against colonialism and slavery. The land was previously seen as a type of security that can be handed down (Skelton. 2000. p70). Evacuation from the South has placed a strain on the areas of Davy Hill and Geralds where a large proportion of relocation has taken place. Geralds in particular has and is facing major changes through the construction of the new Airport to replace Bramble Airport, which was lost under pyroclastic flows on the East Coast. Despite offering 35 new jobs when completed and many during construction, at a cost of $EC42.6 million, the airport will dramatically change a large area of cultivated and inhabited land in the North of the Island meaning yet more relocation for those unlucky enough to be living where the airport is being built. Angela Greenaway (2002) comments that: for sustainable development to be achieved, there must be planning which caters for the local community but also has a healthy respect for the environment. This statement supports the need for sustainable development incorporating the airport but will come as little relief for the residents of Geralds who could well be relentlessly affected. The airport is however, very important to the development and safety (in terms of evacuation) of the island as more passengers will be catered for in light aircraft than the heliport could ever support. The questionable closure of the port (Osbourne, 2003) however, and removal of a twice-daily ferry service capable of carrying over 300 passengers is likely to hinder the development process until larger aeroplanes are able to service the island. For this to be the case, the runway must be extended which, according to the head of construction for the airport, is impossible given the shape of the land. Montserrat is characterised by a unique social and economic structure following the recent volcanic activity. Once self-sufficient and striving for independence, Montserrat is now more dependent than ever on Britain. The island once boasted low levels of unemployment and one of the highest standards of living in the Caribbean and up until the 1995 eruptions, had not received budgetary aid from the UK since 1981 (Skelton, 2000). The extent of Montserrats substantial borrowings (Cassell-Sealy, 2002) following 1995 was highlighted by the Chief Minister John Osbourne, who when interviewed, estimated that 80% of development funding post-volcanic event was received from the UK and EU. A return to self-sufficiency by 2007 is a target set out by the Montserratian government despite the admittance that independence is now impossible for the foreseeable future (Osbourne, 2003). As a direct result of the volcanic activity and threat of future such occurrences highlighted by the introduction of the exclusion zone in October 1996, much of the aforementioned population reduction was through migration to other Caribbean islands (predominantly the neighbouring Antigua to the North and Guadeloupe to the South), North America and most importantly the United Kingdom (Mainly due to colonial links). The decrease in population generated several negative effects such as the dramatic reduction in revenue from taxes and a productivity base loss of 95% (resulting from the dramatic reduction of both males and females in the main productivity age group of 15 64 years old) (DFID, 1999). Similarly, the island is experiencing the brain/skill drain, which symbolises the loss of talent and intellect to other countries from the same age group. Attracting Montserratians back to the island is proving a difficult task mainly due to the rates of pay, which are low in comparison to other countries such as the UK. Services such as education suffer considerably as a result with the lack of teachers hindering future development of the education system. This is a problem which the government hopes to ease with the use of subsidies from the UK, should they become available. Pre-1995 the economy was primarily service-based with a significantly large female workforce acting as both producers and reproducers (Skelton, 1989). Since the volcanic activity began, the depletion of the service industry has meant the majority of job vacancies now exist in the construction industry, an industry dominated by male intake. This male preference is causing a detrimental psychosocial fallout (Barnes, 2001) which has lowered self-perception and worth for women. According to Lee (1996), Montserratians are experiencing the pull of the UK and other locations away from the threat of volcanic activity as well as the push of poverty. In an attempt to achieve sustainable re-development of the island, three major government-backed agencies have been introduced. Firstly, the Montserrat Volcanic Observatory (MVO) provides the siland with detailed analysis of the volcanic activity, mainly through Radio Montserrat. As Jill Morten, director of the MVO (2003) states: The level of trust the people hold for the observatory is evident and the government and emergency department rely heavily on data from the observatory when changing the exclusion zone area or in case of an evacuation. Secondly, the Emergency Planning Department (EPD) was introduced to ensure the minimal impact of any natural disaster possible is experienced. As Horatio Tuitt (2003) from the EPD explained: The department have plans for every conceivable eventuality including Operation Exodus the plan to evacuate the entire island should it be necessary. Finally, the Physical Planning Department (PPD) ensures the most effective use and management of land on the island. Modern techniques are used to develop the island as Angela Greenaway (2003) states: Using base maps, surveying techniques and aerial photography, the department is working towards having the entire island plotted using GIS (Geographical Information Systems). It is hoped that with the successful management of the natural hazards which affect the island, the Tourist Industry will be able to re-develop itself and the national economy. The Government is targeting tourism as the main source of income as it was pre-1995 through re-development and since 1998, figures have steadily increased: * 1999 saw a 37% increase on the figures for 1998 * 2001 saw a further 9% increase on the figures for 2000 (West, 2003) Achieving sustainable development is key to the re-development of the island if it is to build for the future, this is possible in many ways including using the remnants of the eruption for tourism (such as Plymouth in its inundated state) and using the unique culture and habitat that characterises the island as a whole. The second method is perhaps one of the most important. As those who visit the island soon realise, Montserrat features a unique culture which welcomes visitors and when combined with the natural beauty of the island, creates an alternative to many other holiday destinations. Key to the re-development of the Montserratian tourist industry is for the UK to assist in the promotion of the island as a safe tourist destination and to curb the negative media attention surrounding the volcanic eruptions of recent years. Similarly, the promotion of the island needs to be enhanced with help from the UK (where many tourists are likely to come from) and a reduction in the reliance upon word-of-mouth and repeat visitors as mediums. The problems faced by the tourist industry in Montserrat are highlighted by Roselyn Cassell-Sealy of the National Development Fund (2002): Our incapacity to control the quantity and quality of the context of international news releases continues to handicap our attempts to market ourselves as an alternative small island tourist destination as well as a very real potential investment option. Currently, the Caribbean economy as a whole is a very complicated system originating from its colonial history (Boxhill, 1999). Most of the islands are still influenced or governed by their previous colonisers. More recently, the Caribbean countries are in the process of developing the idea of a Caribbean Single Market and Economy. Key features of which include the introduction of a single Caribbean currency, which would be utilised by all the full members of CARICOM (Caribbean Community Common Market) in an attempt to prevent marginalization and the influence of Trans-national Corporations. (Boxhill, 1999) Although Montserrat is a British Territory and is likely to be so for the foreseeable future, it is a member of the Organisation of Eastern Caribbean States (OECS), using the Eastern Caribbean Dollar ($EC) as its main currency. Despite its reliance upon the UK and EU for funding, Montserrat maintains full independent status within the OECS (Skelton, 2000). However, the Chief Minister has highlighted the islands intentions to join the Single Caribbean Currency should the plan come to fruition. Montserrat purveyed one of the stronger Caribbean economies prior to the volcanic crisis (Skelton, 2000). Despite the activity since 1995, the standard of living on the island is still of a reasonable quality and is much higher than on other Caribbean islands areas of Africa and South America. Processes such as Globalization (featuring increased communication and transport links), have attracted migrants from such areas. Montserrat is keen however not to allow the introduction of possible detrimental activities to the island such as drug and gun cultures which could spoil the image and portrayal the island is striving to achieve as part of its sustainable development. The Governor, Chief Minister and Press officer Keith Greaves highlighted such matters as well as the already evident cultural changes which are a feature of the modern global community and are brought to the island by tourists and migrants alike. Such actions do however introduce the possibility of a sense of confusion as to the national identity which Montserratians are attempting to ascertain. As Fergus (1994) comments; Montserrations are still not certain what they are. One part of the Monserratian culture which is evident, and indeed prominent, is the importance of religion to the people. Walking or driving through villages on a Sunday morning immediately presents the level of importance the church holds to the people. There is very little activity, except for those going to or from church. Communities appear to be based around religious activities and groups with most activities being held in the local church hall. It is difficult if not impossible to determine what the future holds for Montserrat and its people. The volcanic activity since 1995 has had several socio and cultural impacts on the Island. The people have been relocated, sometimes on several occasions and are uncertain where their future lies perhaps this is why so many have moved to security and a certain future associated with an alternative sense of being. Many of those who took advantage of the UK governments 2-year exceptional leave to enter granted in April 1996 allowing free entry to the UK for Montserratians. It is also important to point out that those who chose to remain or moved to the island are now located in one third of the original size of the island. Islanders are now therefore living more on top of each other and the scope for future conflicts greater than those already experienced through activity such as relocation is increased. If the island is to achieve sustainable development, the reliance upon the UK and EU will continue for some considerable period and it is difficult to see how Montserratians will be able to achieve a real sense of nationalism and complete identity until the island re-develops considerably. It is not of course a foregone conclusion that volcanic activity will cease in the short term. This raises the question as to whether the Southern area of the island will ever be safe to use again in light of recent events. Either way, the socio-cultural impacts on Montserratians lives are likely to continue until the island achieves a stable economy and structure similar to that which existed pre-volcanic activity. The question remains as to when and indeed if this will happen.

Executive summaries - Emphasis

Executive summaries Executive summaries No matter how well structured and well written your report is, some clients will feel they only have time to read the executive summary and this is particularly true for senior management. So it is absolutely essential that you put a lot of thought into its structure and content: * Make sure the summary can stand alone and that it contains real information, including hard facts and figures. * If your report includes recommendations, make it clear what these are and include their implications, values and costs (if applicable). * Stick to a maximum of two pages. * Use headings and bullets (but not too many), and perhaps a carefully selected graph or pie chart, to get your main message across.

DEAF REFLECTION #2 Coursework Example | Topics and Well Written Essays - 250 words

DEAF REFLECTION #2 - Coursework Example The writer tries to envision if the whole world was a bilingual community where everybody was taught sign language in the same manner they were taught how to speak using their tongues This is an important notion as people were be able to communicate easily with their and extended family of the Vineyard society. This means that there was no language barrier, and by proxy, no social barrier in this society. The writer acknowledges that there were no difficulties that the deaf children suffered on the Vineyard as the society acted as an extended family for them. From childhood, one could obtain families where one or two children in the family were deaf so this would not be a major concern in another child was born deaf. The deaf children stood a better of continuing with their education than students who could be able to hear. This is evident when the writer claims that â€Å"the recommended period of instruction in Hartford was five years but education for the deaf was available up to ten years†. On social aspects, the deaf on Martha’s Vineyard married freely. Though the number of children that were born deaf was quite high and in an alarming rate. The deaf were also able to be independent as they were able to make a living of the talents and skills they had for example a carpenter. With respect to families, the fertility was higher and there was much comparison between the children who are born when hearing and those who were deaf. The Vineyard was a safe heaven for the deaf. However s time went by things started to change, to them deafness was treated like a stigma ans something to be ashamed of. In schools, other student made fun of the deaf students as the student who could hear made fun of them and nobody wanted to learn sign language anymore. This forced the society to open schools for the deaf and lead to a total split-up of those who could hear and the deaf in the society. A perception that the society tends to uphold up to

Entamoeba histolytica Essay Example | Topics and Well Written Essays - 2000 words

Entamoeba histolytica - Essay Example The Entamoeba histolytica is the protozoan responsible for a disease called amoebiasis1. It mainly occurs in the large intestines and causes inflammation as its name suggests. The number of infections worldwide as a result of the parasite can be approximated at 35-50 million people, majority of whom are in developing countries where there is a problem of poor sanitation2. Entamoeba histolytica is a pathogenic parasite that occurs within the intestines and is the sole causative agent of amoebiasis, lack of proper hygiene can be ascribed as be one of the foremost causes of infection by the pathogen. The Entamoeba histolytica is an anaerobic protozoan that causes an infection in the digestive system of mainly humans and other primates2. It is estimated that the parasite has infected approximately 50 million people in the world over and it has had a major role in the morbidity and mortality especially in the developing countries. In addition, animals close to the home such as dogs and cats may also be infected regularly but are not believed to contribute to the transmission of the pathogen3. However, though there are numerous species of protozoa in the genus Entamoeba, not all of them are disease causing organisms. The Entamoeba histolytica is known to cause what is commonly referred to as amebiasis in humans which can either cause internal infections in the intestines or external ones2, 3. Even though some members of the Entamoeba genus are not associated with disease, they are important since they often may be confused with Entamoeba histolytica in diagnostics. Though it has a rather well distribution of incidence worldwide, there is higher incidence of amebiasis in developing countries. Medically speaking, in order for one to get infected by the protozoa, they ought to have ingested mature cysts that may be present in

Select one article from our text book, or one document from the Assignment

Select one article from our text book, or one document from the Internet, and evaluate what you feel are it's strengths and weaknesses - Assignment Example Most organizations face this issue. As there is a change of reality, they do not address moves in their competitive environment and thus find it hard to sustain their competitive advantage. According to the article, the main issues of theory of businesses revolve around connecting the three key parts together. These parts are reality, organizational competency and business focus. The following points are to be kept in mind to keep the theory of business relevant presently and in future. One is that reality is defined by the market place and moves to where it wants. For an organization to be successful, it has to study the changes taking place in the market and know that the key to success is their capacity to determine what the customer is willing to pay for at the moment and in the future. Another factor is that an organization attains focus when it aligns itself with reality. Thus, if it wishes to be successful, it concentrates on the moves in the market place and adjusts its business programs to cater for those needs. After an organization is aware of the changes needed, it has to identify and develop skills and competencies needed to prosper in the long term. The author recommends that organizations ought to review their theory of business continually as there is no business that is static. There are also times that organizations ought to be cautions like in the startup stage, times of fast transformation, unforeseen failures or success and when the organization is about to attain its present goals and objectives. The objective of the article is to address business theory. It is to address where organizations go wrong so that they do not achieve success and the solutions that they ought to embrace and apply. The author of the article accomplishes this objective by addressing where the problem comes in. At the end of the article, solutions are offered. The author states that,

Dissolution Profile of Paracetamol Generics

Dissolution Profile of Paracetamol Generics 1 Introduction The pharmaceutical industry had an estimated turnover of $773 billion in 2008,1 however not all of this revenue was taken as profit; a significant cost goes into research and industry guideline compliance. With regards to new generic medications, proving bioequivalence is crucial to success, however necessary in vivo testing can be costly.2 Drugs which meet certain Biopharmaceutics Classification System (BCS) criteria may be exempt from these expensive tests and can be permitted a biowaiver.3 This allows in vitro dissolution testing in place of in vivo plasma analysis. Paracetamol is one such drug that has qualities which place it at the borderline of biowaiver suitability.3 It is the worlds most commonly used analgesic4 and the question arises as to whether all preparations are as effective as each other? More specifically we ask, is there is any significant difference between the dissolution profile of paracetamol generics? This literature review is in preparation of experimental t ests designed to ascertain if there is any difference in dissolution profile of eight bioequivalent preparations listed on the Australian Pharmaceutical Benefits Scheme (PBS), and whether this difference may correlate to a clinical significance in such a common place drug. 2 Search Strategy All data was sourced through internet databases, i.e. Medline, Pubmed, and the Cochrane Library. The search engines Google Scholar and UWA library were also utilized. Keywords included. KEY WORDS Paracetamol, acetaminophen, bioequivalent (therapeutic equivalency), Delayed-action Preparations, Pharmaceutical Preparations, Tablets, Drug Compounding, Chemistry, Pharmaceutical, Observer Variation, Dissolution, Metabolism, in vitro, in vivo, IVIVC, Drug Content, Bioavailability and Correlation. Boolean searching was utilised to broaden or narrow search results and once appropriate articles were sourced, citing and cited articles were also evaluated. 3 Paracetamol 3.1 History Paracetamol (acetaminophen) is one of the worlds most popular drugs for the treatment of pain and fever.4 It was first synthesized in 1878 by Morse, and was used clinically for the first time in 1887 by von Merring.4, 5 Paracetamol fell into obscurity shortly thereafter in favour of other chemically related drugs such as phenacetin.5 However, phenacetin was later found to be nephrotoxic, and the search for a substitute arose.5 In 1950, a study from Brodie and Axelrod rediscovered paracetamols suitable analgesic properties.4 Although, this drug did not experience widespread acceptance until the 1970s due to unfounded concerns about safety; but from then on, it became the most commonly used medication for pain.4 In many countries, such as the United Kingdom, paracetamol sales have exceeded those of aspirin since 1980.4 3.2 Physicochemical properties Paracetamol or N-(4-hydroxyphenyl) acetamide, is a white crystalline powder with a melting point of 168-172C (Martindale). It is sparingly soluble in water, ie. one part of paracetamol is soluble in 70 parts of water at room temperature.3 It is also freely soluble in alcohol. (Martindale) Paracetamol shows maximal UV absorption at a wavelength of 249nm and is reported to have a pKa of 9.5 at 25C.3 3.3 Pharmacology Pharmacokinetics 3.3.1 Pharmacodynamics Mechanism of Action The exact mechanism of action of paracetamol has remained largely unknown for some time.6-9 For years it has been thought to inhibit the enzyme cyclooxygenase (COX) in a similar manner to non-steroidal anti-inflammatory drugs, however definitive proof of analgesia and antipyresis being dependent on COX inhibition is still lacking.4 Recently, two independent groups have produced experimental data that has demonstrated that analgesia involves the potentiation of the cannabinoid vanilloid tone in the brain and in the dorsal root ganglia.4 Blockade of cannabinoid (CB1) receptors in rats has eliminated any analgesic properties of paracetamol and suggests that paracetamol is in fact a cannabinomimetic.4 3.3.2 Pharmacokinetics 3.3.2.1 Absorption Bioavailability: Paracetamol has been reported to have a bioavailability of 62%-89% in those of a fasted state,3, 8 this divergence from absolute bioavailability is attributed to first pass hepatic metabolism. Peak plasma concentrations are reached between 0.17-2.0 hours post-dosing.10 As expected, food has been shown to reduce absorption by increasing tmax and decreasing Cmax values. Food has not been shown to affect the amount of acetaminophen reaching the blood.3 3.3.2.2 Distribution: Paracetamol has a reported volume of distribution of 0.69-1.36L/Kg.11 Around 20%-25% of the drug is bound to plasma proteins at therapeutic dosages; however this value has been shown to increase to 20%-50% in over dosage. Paracetamol has also been shown to cross the placenta, and has a 1.24 milk/plasma ratio in breast milk.3 Paracetamol is an ADEC category A drug, i.e. it is safe to use in pregnancy, as well as breastfeeding.9 3.3.2.3 Metabolism Excretion: Around 85%-90% of paracetamol is metabolized within the liver via the process of glucuronidation and sulfation.3 These inactive metabolites are then eliminated by the kidney in the urine. Approximately 5% of paracetamol is passed out unchanged in the urine, the remaining drug is conjugated with cysteine and mercapturic acid.3, 8 The half-life of paracetamol has been reported as 1.9 4.3 hours3, 8, 10 but longer in those with renal impairment. 3.4 Indication Paracetamol is indicated in the symptomatic treatment of mild-to-moderate pain as well as fever3, 9 and has also been described to have mild anti-inflammatory properties.3 3.5 Dose Dosage Forms For adults, the optimal single dose of paracetamol is 1g,3, 9 with a maximum dose of 4g daily.9 Hepatocellular necrosis can occur from doses of 10-15g, and death may result in doses in excess of 20-25g.3 Paracetamol is available in many dosage forms, as a single active pharmaceutical ingredient (API), or in combination with other analgesics such as codeine (Panadeine), dextropropoxyphene (Di-Gesic), metoclopramide (Metomax), as well as in combination with decongestants such as pseudoephedrine in cold-and-flu preparations.9 This drug is available as immediate release (IR) tablets, sustained release (SR) tablets, chewable, elixirs, IV injections and suppositories.9 4 Biopharmaceutics Classification System The Biopharmaceutics Classification System (BCS) is a method of grouping active pharmaceutical ingredients (API) based on their solubility and intestinal permeability.12-16 The system allows for easy identification of those drugs whose in vivo absorption can be easily anticipated based on their in vitro dissolution.12, 15, 16 This implies that two different products containing the same drug will have the same rate and extent of absorption if, over time, they both have the same concentration profile at the intestinal membrane.12 Since it is the dissolution profile of a drug which determines its concentration profile in the intestinal lumen, comparability of this parameter in vitro should produce comparable absorption results in vivo.12 In reality however, only those drugs with high permeability which are formulated into IR preparations can be easily and reliably applied to this logic.12, 15, 16 4.1 BCS Drug Classes There are four classes within the BCS to which a drug can be assigned (as outlined in figure 1). Class I is comprised of those drugs with high permeability and solubility, these drugs are expected to be well absorbed and, providing dissolution is slower than gastric emptying, show a good correlation between in vitro dissolution rate and the rate and extent of in vivo absorption (IVIVC).12, 15, 16 Class II drugs also have high permeability but their solubility is low which ensures in vivo dissolution is the rate limiting step in drug absorption and thus IVIVC is expected.12 Class III drugs have a low permeability with high solubility, traditionally these drugs were believed to have little or no IVIVC,12 however recent studies have shown that if a class III drug is very rapidly dissolving then a correlation may exist.18, 19 Finally Class IV drugs have both low permeability and solubility these drugs are not expected to show any IVIVC.12 For each of the four BCS classes a drug substance is considered highly soluble when the highest [IR] dose strength is soluble in 250mL or less of aqueous media over the pH range of 1-7.5.16 The permeability of a drug is considered high if greater than 90% of a dose is absorbed across the intestinal membrane.16, 20 Using these definitions, paracetamol is classified as a BCS class III drug but it is also described as borderline class I because it is only just on the cusp of low permeability.3 4.2 Utility of the BCS The genius of the BCS is that it allows easy identification of drug candidates for which relatively cheap and fast in vitro dissolution testing can replace the more expensive, time consuming and invasive in vivo absorption testing.2 The system does away with complex bioavailability modeling that must account for fasted and fed states as well as cyclical changes in motility and gastric emptying.12, 14 The impact of the BCS on the pharmaceutical industry was so great that in 2006, creator Dr. Gordon Amidon was awarded the International Pharmaceutical Federation (FIP) Distinguished Scientist Award.21 5 Correlation between in vitro dissolution and bioavailability Following the introduction of the BCS a great deal of research was conducted exploring the power of IVIVC. It became a main focus not just of the pharmaceutical industry but also of academia and regulatory authorities.2 IVIVC became popular because it can be used as a substitute for resource intensive bioavailability testing; the concept has essentially improved the speed and cost of drug development as well as quality control in pharmaceutical manufacturing.2 5.1 Bioavailability and Bioequivalence Bioavailability is an important concept because it determines the efficacy, safety and reproducibility of the therapeutic effect of drugs and the many formulations in which they come.22 For the purpose of drugs that produce a systemic therapeutic effect, the Australian Therapeutic Goods Administration (TGA)22 defines bioavailability as the extent and the rate at which a substance or its active moiety is delivered from a pharmaceutical form and becomes available in the general circulation. Bioavailability is therefore inherently linked to drug absorption and may also be predicted using IVIVC as defined by the BCS. If two pharmaceutically equivalent (same active ingredient and content in the same formulation) products have the same bioavailability they are considered bioequivalent and will essentially have the same efficacy and safety. Bioequivalence is important because it is the basis for which innovator medicines can be substituted with generics. 5.2 Strength of in vitro in vivo correlations The BCS is a predictive tool for determining which drugs will have an IVIVC. Table 1 demonstrates that under the BCS only class II along with some class I drugs are expected to have IVIVCs.12 Research subsequent to Dr. Amidons first BCS publication has generally upheld his initial findings however exceptions to the rule have been found. 5.2.1 Drugs with IVIVC The BCS suggests that if the bioavailability of a drug is dissolution rate limited then a good IVIVC should be possible. This notion has been demonstrated for flutamide a very poorly soluble high dose compound which is not expected to have IVIVC but has dissolution rate limited absorption.23 A paper published by Posti, Katila Kostiainen23 concluded that there is a strong IVIVC for flutamide and this was identified on four separate occasions where bioavailability was studied. All four studies were of single dose, cross over design and each subsequent study increased the number of subjects tested (study I: n = 6, Study IV: n = 24). The strength of the papers methodology provides good support for its conclusions however this was undermined by a lack of documented statistical analysis. Much more compelling evidence comes from a study by Sakuma et. al.24 which was able to show an IVIVC for two BCS class I drugs after they received an enteric coating, thus eliminating the possibility that gastric emptying was the rate limiting step. The results were statistically significant, however the tablets were tested in rat models rather than human subjects and the dissolution test may not have adequately reflected the in vivo environment that enteric coated tablets are subject to.24 Further studies in human subjects demonstrating the difference in IVIVC between enteric and non-enteric coated tablets could not be identified in the literature. There are hundreds of other drugs which have an IVIVC and these are neither limited to BCS class II drugs or drugs with dissolution rate limited absorption. Theophylline is a BCS class IV drug and yet in a complete cross over study of four different theophylline tablets the in vitro dissolution was able to significantly predict several in vivo pharmacokinetic parameters (AUC Cmax) which dictate bioavailability.25 The study was small (n = 6) and not all pharmacokinetic parameters could be correlated. Other common drug examples with IVIVC include digoxin,26 rifampicin,27 diclofenac28 and lamotrigine29 and these are by no means exhaustive. 5.2.2 Drugs without IVIVC Not all drugs have an IVIVC and this can also include some BCS class II drugs. A research paper by Frick, Moller Wirbitzki 199830 demonstrated that the in vitro dissolution of glimepiride (BCS class II) is not comparable to dissolution in vivo. The study employed a single dose cross-over design with 12 subjects, Latin-Square statistical analysis was employed and the results were assumed to be significant however not all the data was accompanied by supporting confidence values. No correlation was possible because the solubility of glimepiride is low and strongly pH dependent.30 Unlike glimepiride, ciprofloxacin a quinolone antibiotic, is classified as a BCS class III drug and as a consequence would not be predicted to have an IVIVC. Correspondingly, when tested for this possibility none could be found between dissolution and any of the parameters for bioavailability (Tmax, Cmax, AUC Ka).31 5.2.3 Strength of BCS in predicting IVIVC There is a wide variance between IVIVCs that are anticipated according to the BCS and those that are actually demonstrated after experimental testing. Examples have been provided where both expected and unexpected correlations occur and this suggests that the BCS system while helpful should only be taken as a guide. Laboratory testing is still the only reliable method for determining if a correlation is occurs. Paracetamol is a BCS class III medication and as such is not expected to demonstrate strong IVIVC. Given the fact that paracetamol has a wide therapeutic index and the BCS can only be used as a guide, a safe and useable IVIVC may still exist. 5.2.4 IVIVC of paracetamol The prodigious use, vast quantities manufactured and the presence of many generic products in the marketplace makes paracetamol a prime candidate for IVIVC testing. In 1996 Retaco et. al.32 conducted a small crossover study using five subjects to assess whether an IVIVC for paracetamol may exist. The study stated that the absorption data from saliva partially correlated with those found in vitro,32 this however is not a valid conclusion. One of the subjects studied produced in vivo data that opposed a correlation and this anomaly was further confounded by the fact that statistical analysis was not performed on the IVIVC but rather covered the in vitro and in vivo data separately. This pilot study was later contradicted by Babalola et. al.33 who found limited IVIVCs and suggested that paracetamol absorption may not be limited by its dissolution rate. Similarly, a thorough, well designed, complete crossover (44) study that balanced for first order residual effects, suggested that it wa s dangerous to use dissolution as the sole test for paracetamol bioequivalence.34 Interestingly, all of these studies demonstrated bioequivalence between the various products of paracetamol even if they showed no IVIVC. 6 Biowaiver for bioequivalence testing In vivo bioequivalence studies are required to ascertain the potential differences in bioavailability between innovator and generic products which, may lead to therapeutic inequivalence. A biowaiver provides the authority and grounds for fiscally intensive bioequivalence testing to be replaced by more tolerable in vitro testing. For the most part, IVIVC must first be established in order for a drug to be considered for a biowaiver. The BCS has outlined properties of solid preparations which require evaluation in biowaivers, i.e. solubility, permeability, and dissolution rate.35 In addition to this, the non-critical therapeutic range of a drug should also be considered35 and this is the basis for which paracetamol has gained biowaiver status.3 It should be noted that products produced by the same manufacturer at the same site are exempt from bioequivalence studies.36 6.1 Paracetamol Biowaiver Several characteristics must be considered when a drug presents as a candidate for a biowaiver through dissolution testing. Paracetamol is not a classic biowaiver candidate because it is classified as a BCS Class III drug, it does however possess properties borderline to Class I3 and these enable it to fulfill the requirements of a biowaiver. 6.2 Biowaiver requirements 6.2.1 Characteristics relevant to the active ingredient 6.2.1.1 Risk of therapeutic failure or adverse drug reactions i.e. the need for critical plasma concentrations. When considering a biowaiver for a drug substance, its therapeutic use and therapeutic index also needs to be taken into account.16 In the case of paracetamol, the therapeutic indications are not critical, and there is a wide difference between the usual therapeutic dose and toxic doses. Given that an optimal therapeutic dose for an adult is 1g, and that hepatocellular necrosis can result from ingestion of 10-15g, it can be assumed that paracetamol is not a narrow therapeutic index drug.3 6.2.1.2 Risk of bioinequivalence: Previous evidence of bioavailability problems for an active substance can complicate the justification of in vitro dissolution bioequivalence correlation.35 For paracetamol, the absolute bioavailability has not been shown to vary between therapeutic dose ranges of 5-20mg/kg.3 Other studies have also demonstrated that bioequivalence in different IR paracetamol preparations is achievable.11, 32, 37 6.2.1.3 Solubility: If a drug is highly water soluble it generally lends to exemption of bioequivalence testing, however polymorphism and particle size are major determinants of dissolution and must be considered.35 A drug is considered highly soluble if the amount contained in a preparation of maximal strength dissolves in 250mL of three buffered solutions ranging between a pH of 1-8 at 37C.35 Paracetamol has a pKa of 9.5 and is therefore not substantially ionized at a pH less than 9. As a result, it can be said that its solubility does not vary with pH.3 The highest strength IR preparation of paracetamol is 500mg. Experimentally, this has been shown to dissolve in 21mL,3 which is significantly less than the 250mL that is required by the BCS guidance to prove solubility.16, 35 6.2.1.4 Pharmacokinetic properties: High permeability which is typically indicated by a linear absorption pattern, reduces the potential influence of an IR preparation on bioavailability.35 For paracetamol, the permeability is slightly below the cut-off value of 90%, i.e. one study by Stewart et al.38 found permeability to be 80% once absorbed. This formally excludes paracetamol from being considered for a biowaiver, although extensions to BCS Class III drugs have recently been given more attention.20, 39 6.2.2 Characteristics relevant to the medicinal product 6.2.2.1 Rapid dissolution: Dissolution profiles can be regarded as equal when more than 85% of the active ingredient is dissolved within 15 minutes.35 This comparison must occur between test and reference product in three buffers which with a pH range between 1-8, at 37C.35 Paracetamol tablets have been shown to dissolve within 30 minutes,32 however this rate does not satisfy BCS exemption standards. 6.2.2.2 Excipients: Those included are to be well established and not in atypically large quantities. Kalantzi et al.3 details a table of acceptable excipients which can be used within paracetamol IR tablet formulations which are considered for in vitro dissolution biowaiver. 6.2.2.3 Manufacture: Critical parameters such as particle size and polymorphism should be addressed and documentation should be provided in the dossier that is submitted to TGA.35 Paracetamol has three metastable forms, the only commercially available from is the monoclinic acetaminophen as it is the most thermodynamically stable polymorph.3 From review of the literature, it can be concluded that in vivo bioequivalence testing of solid, oral IR paracetamol dosage forms may not be necessary. This can be justified given that a paracetamol formulation can be shown to:3 Rapidly dissolve under USP guidelines Contain only the acceptable excipients, in usual quantities Demonstrates dissolution profile similar to reference product under conditions stated in USP guidelines 7 Statement of Purpose 7.1 Aim hypothesis The purpose of the proposed study is to compare the dissolution profiles of bioequivalent IR paracetamol preparations listed on the PBS. In particular, comparisons between every preparation will be made, rather than a single comparison against a referent. We hypothesize that there will be no significant difference between the dissolution profile of IR paracetamol tablets when dissolved according to USP specifications. 7.2 Methodology We propose to analyse the dissolution profiles of eight PBS listed bioequivalent paracetamol preparations, namely; APO-paracetamol, Chemmart Paracetamol, Dymadon P, Febridol, Panamax, Paracetamol Sandoz, Paralgin, and Terry White Chemists Paracetamol. Sixteen tablets of each preparation will be dissolved in compliance with USP dissolution test for tablets and capsules, using apparatus II. As mandated, tablets are to be dissolved in 900mL phosphate buffer at a pH of 5.8 with a paddle set to 50rpm. Samples will be taken at intervals of 2,5,10,15,30,45,60 minutes in concordance with practice by Dominguez et al.34 these aliquots will be examined for paracetamol by UV spectrophotometry at 289nm. These data will be statistically analysed by ANOVA. 7.3 Timeline Date Tasks to be performed Work Deadlines Week 11 (15.03 21.03) Create paracetamol standard curves, Test expected dissolution time, Order materials, Source test tablets, Visit school of statistics for advice. Literature Review Due Monday 15th March 12pm Week 12 (22.03 28.03) Testing of tablets 1 2: Dissolution UV vis Week 13 (29.03 04.04) Testing of tablets 3 4: Dissolution UV vis Week 14 (05.04 11.04) Testing of tablets 5 6: Dissolution UV vis Week 15 (12.04 18.04) Testing of tablets 7 8: Dissolution UV vis Week 16 (19.04 25.04) Week in lieu to finish experiments in case of unforeseen circumstances Week 17 (26.04 02.05) Data collation statistical analysis Briefing on the writing of the final report Wed 28.04 2pm Week 18 (03.05 09.05) Writing draft report Week 19 (10.05-16.05) Editing final draft report Week 20 (17.05 23.05) Powerpoint presentation format 1st Draft Research Project Due Friday 21st May Week 21 (24.05 30.05) Correcting draft report Week 22 (31.05 06.06) Amending powerpoint presentation Final report due Mon 31.05 12pm Week 23 (07.06 13.06) Amending final report Week 24 (14.06 20.06) Presentation rehearsal Seminars, submission of amended report to pharmacy office

Japan Caught Between US and China :: essays research papers

Japan caught up in U.S.-China spat Japan came under criticism in the fallout of a heated exchange between the United States and China over Taiwan at the Asia Security Conference here. In fact, some participants said Japan-not China-is the country creating the most fears in Asia. The three-day conference, hosted by the London-based International Institute for Strategic Studies, ended Sunday. A key topic of debate was a Japan-U.S. agreement reached in February on common strategic objectives-including how to deal with Taiwan. The joint statement said the objective was to "encourage the peaceful resolution of issues concerning the Taiwan Strait through dialogue." In his speech in Singapore on Saturday, U.S. Defense Secretary Donald Rumsfeld questioned the validity of China's increased military spending when the country faced no threats, as well as its heightened deployment of ballistic missiles aimed at Taiwan. Cui Tiankai, director-general of the Asian Affairs Department at China's Foreign Ministry, retorted by asking Rumsfeld if the United States felt threatened by the stronger presence of China. Rumsfeld had to diplomatically admit there was no such threat. However, in a subsequent question-and-answer session, both Rumsfeld and Defense Agency chief Yoshinori Ono were asked about the common strategic objective pertaining to Taiwan. Ralph Cossa, president of the Pacific Forum, which is affiliated with the Washington-based Center for Strategic and International Studies, asked Rumsfeld for his interpretation of reports in many Asian nations that the common strategic objective meant Japan and the United States would act together to defend Taiwan. Rumsfeld only said that the contents of the joint statement were in the public domain. Cossa then asked Ono about the growing perception in Asia that Japan and the United States would contain China as a means of defending Taiwan. Ono simply responded that the joint statement should be read carefully. In response to questions from The Asahi Shimbun, one of the sponsors of the conference, Cossa said many nations in East Asia were concerned about Japan's defense policy. "With the issue of Prime Minister Junichiro Koizumi's visits to Yasukuni Shrine also coming into the picture, the view is emerging among Asian countries that the nation truly to be afraid of is not China, but Japan," said a Singapore-based researcher. The latest Asia Security Conference saw the first participation of a delegation of Chinese government officials.

Advertisement In Media Right or Wrong ?

We all are living in the era of commercialism, modernization and sophistication. Where we don’t care of even ourselves in ethical means or as a human being. In our daily life we come across with a lot of events and incidents which put an important impact in our daily life. Here advertisement of different things plays a key role in our life. When talking about advertisement in media, it has both Positive impact as well as stigmatic effects on our lives, which means that up to some extent Advertisement in media is acceptable for our minds; otherwise it is not less than a curse. Lets have a glance in our life in previous times. Yes we were passing through a very simple but pure and meaningful life which was free from advertisements and commercialism. When talking about our society, people were living a balanced life. Our ancestors had given time to each other to establish a mature society. While we talk about the negative impacts of advertisement in news papers, TV or magazines we generally face these type of effects in our Quality of life, like demoralization of our Social as well as ethical values. We have often heard that it is an international rule that every advertisement in media, TV, or magazine must have to pass the Code of Conduct before publishing. In code of conduct there includes various prohibitions, for example use of kids as a a target audience in advertisement is strictly restricted but the situation is reverse in every cultural society apart from Pakistan. Similarly abuse material should not be advertised e. g. Cigarettes advertisement etc We have talked about the demoralization of Social values in our society by advertisement; like for example when we travel through the metropolitan streets we see a lot of Billboards having the display of different products of different types. In these billboards most of companies, advertising their products have displayed ladies to attract the people toward them. Just think as a Muslim, whether it is good or bad? Because Islam has given very respectful status to women. But instead of advocating that status is it right to hang the picture of a lady on billboards? Obviously not . So continue to talk about the negative impacts of advertisement in our society. Now a days advertisement in either media or in Newspaper, and magazines have become more glamour oriented. These glamour oriented advertisements. It is there fore said that Advertisement in an exaggerated way has created a destructive effect in our attitudes, habits and mindsets. For example in our society like Pakistan here more than 7o% people run after his bread and butter of life. Glamour in advertisement or exaggeration in advertisement creates greediness among people. Because one thing is very simple and clear that ‘’EVERY ONE FIGHTS FOR THE THING, HE DOES NOT HAVE’’ Said by Hitler. Most of the time the products that are advertised on sign boards or TV, media and magazines are costly. That’s why people want to get those things by hook or by crook. As we see that glamour in advertisement of different products attracts people of society. In other words it creates feelings of Self deprivation among people which consequently boost up the crime rate in our society so we can say that glamour in advertising create a negative role in our lower middle class and in lower Class people. Similarly we live in Pakistan where like every cultural society in the world , a layman is unable to get the basic necessities of life, so when we see the different companies advertising their products in a quite aggressive fashion, these companies spend lot of money on it. But the simple thing is that if these companies spend money on advertising in a moderate way, then they people can save a lot of money and can improve the quality of life of poor people . We should not ignore the positive effects of advertising as well. While talking about the positive impacts of advertising. We can say advertising is a gateway of information of new things, products, services and awareness. In the recent technological era there is introduction of various new things including electronics, household appliances, pharmaceutical products and etc. So awareness regarding these things are very much needed at public level. In this regard Advertisement has played a vital role to upgrade the life of human beings in our society. Advertisement in TV. Newspaper and in Magazines etc has improved the taste of slice of life of people in a positive way as well. When we talk about the health segment of society we shall come to know that by spreading awareness about different topics or diseases, our people have improved their way of living as well as their health. In this regard we if focus diabetes, we will conclude that a decade ago diabetes in our society considered to be a deadly disease but know of course advertisement in media an at public level has totally change the old concept of diabetes. Similar is the case with other awareness programs of health as well. Advertisement is a very ready and sophisticated source to spread the information. I think that if advertisement is in moderate way and if it is not like that of today, the automatically we can balance our society and regain the loosed rapport among ourselves and each other.

Genetics3 essays

Genetics3 essays Why is AIDS so difficult to cure? How does the AIDS virus attack the body? In 1979, the first reported AIDS case occurred in New York, and by mid-June 1981, unusual immune system failure among gay men was surfacing in the United States. The Centers for Disease Control (CDC) initially name the disease GRID, or gay-related immune deficiency, because it was prominently found among homosexuals. It appeared to be a lifestyle-associated illness, linked to excessive stress to the immune system. Researchers believed that a highly infectious agent, which depleted T cells and could be transmitted through intercourse, blood, or blood products from mother to fetus, caused GRID. In July of 1982, the disease was renamed AIDS, or Acquired Immune Deficiency Syndrome. Since then, the diseases origins, the factors affecting it, the causes behind it, the symptoms arising from it, the groups at risk from it, and the practices leading to it have been widely and comprehensively researched. Despite painstaking efforts and billions of dollars spent on research, despite the nume rous drugs created to control and relieve its various symptoms, there is still no cure for it. We ask the question, Why?. AIDS is caused by the human immunodeficiency virus, or HIV. HIVs coat of protein fits the receptors in certain types of white blood cells (T cells) in the human immune system. When the virus is taken into these cells, it reproduces and destroys the immune system cell in the process. It attacks the body by attacking the immune system, making the person susceptible to and defenseless against many infections that he or she would normally be able to fight off easily. In many cases, HIV infection leads to AIDS, which ultimately leads to death. HIV is a retrovirus that is transmitted by the exchange of bodily fluids usually through sexual acts and the sharing of drug needles, mother to infant transmission, and sometimes by the con...

Origins and Management essays

Origins and Management essays In the Middle Eastern culture, terrorism has been an effective way to cause pandemonium for the purpose of political manipulation. The Middle Eastern interests are not cohesive or powerful enough to directly or successfully advocate against the compelling interests of the United States. It cannot face an opponent the size of the U.S. in a military or political fashion so the solution is to resort to a lesser, but equally effective state of domination, by fear. The only way for them to achieve a victory is through random destruction of property or innocent, unsuspecting human victims. Terrorism has been an effective technique for the weak to have an effect over the powerful. From the Middle East's rage against America to the civil war in Ireland, terrorism has taken on many forms. For the purpose of this paper, the Middle Eastern angle and involvement of the United Nations will be discussed. WESTERN PERCEPTIONS OF THE MIDDLE EASTERN TERRORIST Most Americans see Middle Eastern terrorism as a Hollywood depiction. It is not surprising that the American view of the Middle Eastern terrorist is of a psychopathic Islamic without a conscious or reason. In American movies the terrorist is portrayed as a bomb strapped kamikaze that blows up innocents. The seeds of reality are dramatized and the image gives an impression that the Middle Eastern terrorist is not systematic and purposeful. It is assumed that Middle Eastern terrorists act out of religious belief. In reality, this concept is not a logical one. The Muslim, or Islamic religion, does not condone murder. The terrorist groups may use religious concept for political and social momentum, but in fact the true interpretation of the faith cannot be rationalized into their actions. If a terrorist uses the name of Islam to justify their attack, they are blatantly lying. Like all the other religions of God, Islam promotes peace, love and harmony among the people. Actually the w...

Globalization Issue according toThomas L. Freidman and William J Essay

Globalization Issue according toThomas L. Freidman and William J. Duiker - Essay Example The book portrays a scenario where untimely flattening of the opponents of globalization is inevitable. William (2009:340-344) shares his sentiments in his book ’The contemporary world History’. He feels that the forces of fragmentation are too strong to allow globalization to gain a stable footing. Critical analysis of the thoughts of the two writers tempts an individual to take a position. Although William presents steep challenges to globalization, the basis of his arguments and speculation are on uncertainties. The past global trends have shown that globalization has received positive attention all over the world. Although some nations may not appear in public to support globalization, researches have shown that it remains a hot subject in their boardroom meetings. This shows that globalization is live and soon the world will be a global village. Thomas explicitly lays out the benefits of globalization. However, he does not overlook the possible challenges that glob alization might be faced with. This makes Thomas’s convictions correct, more sensible, and real in the current world. The Dell Theory of Conflict Prevention which Thomas subscribes to affirms that there cannot be disagreement between countries, which share a common interest. He emphasizes that globalization is the sole solution to the most conflicts in the world. In essence, Thomas signifies that the nations that embrace globalization have reaped benefits and not enmity. Globalization is the only safe platform to enrich cultural, economic, technological, and political ties while appreciating diversity. Thomas points out that there are still impediments to globalization. He argues that overcoming anti-global forces must be at the heart of its proponents. Freidman (580-604) highlights some of the issues which include poor education systems, weak economic powers, diseases, and bad infrastructure. Compromised education system negatively affects globalization. This is evident in t he third world countries where only the privileged in society acquire quality education and skills.

Analysis of the Picture Girl with Pearl Earring Created by Johannes Essay - 10

Analysis of the Picture Girl with Pearl Earring Created by Johannes Vermeer - Essay Example I’ve heard about the work of art earlier, but I have never thought about it as a great masterpiece. About a year ago, I read an article, about the most significant pictures of the world and found out that â€Å"Girl with a pearl earring† was one of them. I thought that it might be a really good picture, as the filmmakers even created a movie, which showed the audience the history of its creation. A few months later, my friend invited me to attend a local art gallery and I agreed. Going around the boring representations of nature and abstract figures, which meaning I could not understand, I ran against one reproduction, which attracted my attention and it was â€Å"Girl with a pearl earring†. I came closer to it in order to analyze it in greater details. A few minutes I stood calmly looking at the elements of the picture, trying to figure out of what everyone found so special about it. Dark ground, light face’s shades and the most important - sad, but a mys tique look of the girl, which hid some kind of a secret. I looked attentively on the main heroine of the picture. Who was she? Where was she from? Why did she look so sad? What is her history? On my way home, I noticed that I thought over these questions, trying to answer them. At home, I decided to search for this information on the internet. However, there was very little data about it. It is not known whether the author wrote it for himself or somebody else. According to one of the versions, the artist depicted his own daughter Mary. In any case, it is clear that this is an unusual portrait. The artist tried to capture the moment when a girl turns her head towards the viewer to someone whom she had just noticed. Much attention is focused on the girls’ pearl earring. The picture was painted by means of oil. The author used an unusual technique â€Å"tronie†, which was typical for the XVII century.