Trial Of DMXB-A in Schizophernia - Free Essay Example

Sample details Pages: 2 Words: 552 Downloads: 7 Date added: 2019/10/10 Did you like this example? Dimethoxybenzylidene which is abbreviated as DMXB-A is a drug is administered orally. It helps improve neuropsychological and attention in schizophrenia, hence an improved psychological outcome. There were three teams which were in the production of the drug and they were exploratory development team, project development team, clinical development and brand development team. They were tasked with discovery research, exploratory and full development, filling, launching and growth and maintenance. The major team was the clinical development team whose main roles were developing a clinical development plan, manage its execution and compiling the clinical portion of the regulatory submission in form of a case report form (CRF). There are two models under study design. These are traditional model and Innovative/adaptive model. Traditional model is further divided into phase 1,2,and3. Phase 1, the drug safety and tolerability must be established. One has to start with no-effect dose then later on take maximally tolerated dose. The dose range of cover 3-5 fold difference. During the initial stages single dose is recommended but between 5-7 days, multiple dose is advised.   Under phase 2 is further subdivided into phase 2a and phase 2b, the sample size is usually above 50 patients depending on the state of the disease. Its duration is between 1-5 year and studies conducted on patients and volunteers. Don’t waste time! Our writers will create an original "Trial Of DMXB-A in Schizophernia" essay for you Create order Phase 2a which also known as pilot studies. Its initial step also is to determine the safety, efficacy and tolerability in patients, tolerated dose range in patients is also established. Thereafter evaluation is done on relevant biomarkers and pharmacokinetic parameters in patients. Estimation of degree of variation is also essential. Proof of concept states that the drug must demonstrate right pharmacology, appropriate therapeutic index and reach intended target and intended tissues. It should also be enriched with collection of data such as plasma and genomic (Meyer et al.). Adaptive trial uses accumulating data from ongoing study. Its advantage is that it increases the likelihood of selecting phase 3 dose and it use more ethical treatment considerations. The early phase of adaptive trial is to find safe and effective dose while the later phase makes prospective changes to future trials. The traditional plan of adaptive design takes a duration of 16-22 week whereby SAD (4-5 dose) and MAD (3-4 dose) are administered. While modified adaptive design takes a duration of 12-18 weeks. Phase 2b one determines the dose range and level of phase 3 while confirming the its primary endpoints and estimating treatment effects. Phase 3 includes pivotal trials which generate clinically and statistically significant evidence. It involves thousands of patients and takes a span of 3.5 years. It was noted that between 2011 and 2015 that on a single pivotal, 50 % of new drug approvals were made (Sagineedu et al.). Treatment groups were Experimental Therapy groups and control groups. Pompe disease showed that 70-80 % of children die as a result of cardiac failure before they attain the age of 1 year. In a case study carried out, it was found that in the treatment of Parkison’s disease by use of antidepressants, 65 % of the patients improved through active drug treatment. In the double-blind study, the percentage of the patients who improved were only 20%. In an early study carried out, it showed that recombinant GAA helped improve cardiac, survival and respiratory functions. It was concluded that patients who received rhGAA had 90% survival chances and were free from ventilation

11 Facts You Should Know about Halloween

The U.S. is a society of consumers, and an economy based primarily on consumer spending, so its no surprise that Halloween is celebrated in  consumerist ways. Lets take a look at some interesting facts about Halloween consumption and consider what they mean from a sociological perspective. Fast Facts About Halloween 171 million Americans — more than half the entire national population — celebrated Halloween in 2016.Halloween is the nations third favorite holiday, but the second favorite for those between the ages of 18-34. It is  less popular with older folks, and more popular among women than men,  according to a 2011 Harris Interactive poll.Not just for kids,  Halloween is an important holiday for adults too. Nearly half the adult population will dress in costume for the occasion.Total U.S. spending for Halloween 2019 was expected to reach 8.8 billion dollars — a decade ago, that figure was just $4.8 billion.The average person will spend about $83 celebrating Halloween.About a third of all adults will throw or attend a Halloween party.One in five adults will visit a haunted house.Sixteen percent will dress their pets in costume.Costume choices among adults differ by age bracket. Among millennials, Batman characters take the number one spot, followed by a witch, anima l, Marvel or DC superhero, and vampire. The number one costume among older adults is a witch, followed by pirate, political costume, vampire, and then Batman character.Action and superhero characters are often the top choice for children, followed by princess, animal, Batman character, and Star Wars character.Pumpkin wins the top spot for pets, followed by hot dog, bumblebee, lion, Star Wars character, and devil. Halloweens Importance in American Culture So, what does all this mean, sociologically speaking? Halloween is clearly a very important holiday in the U.S. We can see this is not only the patterns in participation and spending  but in what people do to celebrate the holiday. Early sociologist Émile Durkheim observed that rituals are occasions upon which people in a culture or society come together to reaffirm their values, beliefs, and morals. By participating in rituals together, we activate and reaffirm our collective conscience — the sum of those beliefs and ideas we share in common,  that take on a life and force of their own due to their collective nature. In celebration of Halloween, those rituals include dressing in costume, trick-or-treating, throwing and attending costume parties, decorating homes,  and going to haunted houses. This raises the question of what values, beliefs, and morals are reaffirmed through our mass participation in these rituals. Halloween costumes in the U.S. have evolved away from the holidays social origins as taunts and mocking of death, and toward popular culture. Sure, witch is a popular costume for women, and zombies and vampires are also in the top ten, but the variations tend to lean more toward sexy than scary or evocative of death. So, it would be false to conclude that the rituals affirm the values and beliefs of Christianity and Paganism. They point instead to  the importance placed on having fun and being  sexy in our society. But, what also stands out is the consumerist nature of the holiday and the rituals. The primary thing we do to celebrate Halloween is buy stuff. Yes, we go out and get together and have fun, but none of that happens without first shopping and spending money — a collective 8.8 billion dollars. Halloween, like other consumerist holidays (Christmas, Valentines Day, Easter, Fathers Day and Mothers Day), is an occasion upon which we reaffirm the importance of consuming in order to fit in with the norms of society. Thinking back to Mikhail Bakhtins description of medieval Carnivale in Europe as a release valve for the tensions that arise in a highly stratified society, we could also surmise that Halloween serves a similar function in the U.S. today. Currently, economic inequality and poverty are at their greatest in the nations history. We are faced with an incessant onslaught of terrible news about global climate change, war, violence, discrimination and injustice,  and disease. In the midst of this, Halloween presents an attractive opportunity to take off our own identity, put on another, shake off our cares and concerns, and exist as someone else for an evening or two. Ironically, we may be further exacerbating the problems we face in the process, by perpetuating the hypersexualization of women and racism via costume, and  by handing our hard-earned money over to already wealthy corporations that exploit laborers and the environment to bring all the Halloween goods to us. But we sure have fun doing it.

Article Line Management Competence The Key For...

According to, (Donaldson, Yarker, Lewis, 2008), the article Line management competence: The key to preventing and reducing stress at work. Strategic HR Review, 7(2) states, â€Å"In the UK, Health and Safety Executive (HSE), was concerned about their employees. The company according†, (Donaldson et al., 2008), believed that work-related issues was due to stress. HSE has established Management Standards for stress at work that are designed to help employers tackle the major sources of work-related stress risk (Donaldson et al., 2008). The standards that was set place will be shown and if they were effective for the company. Additional components will be given that can also help the organization with the effective ways stress on the job was handed. Some companies spend numerous of dollars to make sure that employees are treated for their illness. I will show the cost of treatment and if manage correctly all employees could benefit from training. A comparison to other organization s stress management program with how other stress models might be implemented will be given as well. According to (Donaldson et al., 2008) â€Å"Work-related stress is now a major concern for employers. In the UK, Health and Safety Executive (HSE) conducted a survey with Chartered Institute of Personnel and Development (CIPD, 2007), shows that work-related stress, depression or anxiety account for an estimated 12.8 million lost working days per year. Around one in seven working individuals think their jobShow MoreRelatedHsg 6529900 Words   |  120 PagesHealth and Safety Executive Successful health and safety management This is a free-to-download, web-friendly version of HSG65 (Second edition, published 1997). This version has been adapted for online use from HSE’s current printed version. You can buy the book at www.hsebooks.co.uk and most good bookshops. ISBN 978 0 7176 1276 5 Price Code BE Successful health and safety management was prepared by HSE as a practical guide for directors, managers, health and safety professionals and employeeRead MoreOperational Risk Management50825 Words   |  204 Pages≈√ F M A G u i d e l i n e s on Operational Risk Management These guidelines were prepared by the Oesterreichische Nationalbank in cooperation with the Financial Market Authority Published by: Oesterreichische Nationalbank (OeNB) Otto-Wagner-Platz 3, 1090 Vienna, Austria Austrian Financial Market Authority (FMA) Praterstraße 23, 1020 Vienna, Austria Produced by: Oesterreichische Nationalbank Editor in chief: Gà ¼nther Thonabauer, Communications Division (OeNB) Barbara Nà ¶sslingerRead MoreProject on Stress Management9684 Words   |  39 PagesCHP:1 INTRODUCTION What is Stress? Stress is a complex phenomenon. It has been defined in many ways, but simply put; it is the wear and tear of everyday life. 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Whetten BRIGHAM YOUNG UNIVERSITY Kim S.Read MoreBackground Inditex, One of the Worlds Largest Fashion Distributors, Has Eight Major Sales Formats - Zara, Pull and Bear, Massimo Dutti, Bershka, Stradivarius, Oysho, Zara Home Y Kiddys Class- with 3.147 Stores in 70100262 Words   |  402 PagesBeatrice Kogg Responsibility in the Supply Chain Interorganisational management of environmental and social aspects in the supply chain Case studies from the textile sector Doctoral dissertation the international institute for industrial environmental economics Lund University, Sweden  IIIEE DISSERTATIONS 2009:2  Responsibility in the Supply Chain Interorganisational management of environmental and social aspects in the supply chain Case studies from the textile sector Read MoreEthical Challenges in Business Organization (Maybank)5985 Words   |  24 Pages Kuliyyah of Economics and Management Sciences Department of Business Administration Business Ethics MGT 3020 Dr. Naail Mohammed Kamil Ethical Challenges in Business Organization: A Study of Maybank Investment Bank Group Members: Atiqah Bt Dalik 1223400 Aida Abidah Bt Anuar 1220954 Alya Maisarah Bt Zainal 1228000 Nor Amira Suhada Bt Othman 1224892 Ethical Challenges in Business Organization: A Study of Maybank Investment Bank Atiqah Bt Dalik(1), Aida Abidah Bt Anuar(2), Alya Maisara Bt Zainal(3)Read MoreHow to Safeguard the Well-Being of Children and Young People6459 Words   |  26 Pagesthe laws that protected children and young people in the respective UK countries. 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Strategic Entrepreneurship for Creativity - myassignmenthelp.com

Question: Discuss about theStrategic Entrepreneurship for Creativity and Desire. Answer: First personal journal entry set The significance of entrepreneurship within the society that has traditional notions and economies has been increasing at a rapid rate which is defying the obsolete concepts. The creation of new ideas through new ventures in business or the manufacturing of new products, ideas or services into the market so as to generate more value and wealth is the most crucial feature of entrepreneurship. It can include the launching of the new business ventures along with developing the existing products. This can be made to happen at any kind of companies both small and large scaled (Alvarez, Audretsch Link, 2016). The prime motivations of the individuals who are on the path of being entrepreneurs relate to gain on growth and profit. On the other hand, the key characteristics of behavior have been related to the strategic thinking and innovation (Bjrnskov Foss, 2013). When it comes to evaluating me in terms of characteristics of entrepreneurship, it is very important to assess the existing and required traits in the measures of five dimensions such as achievement drive, creativity, desire for autonomy and internal locus of control. The drive for achievement is the prime and most important trait that an individual needs to posses from gaining the interest of becoming an entrepreneur. It is a very important entrepreneurial attribute which would denote my need to work hard for achieving success. It is very relevant in my case of aiming to become an entrepreneur as I have high achievement drive and have the attitude of setting targets that are demanding for myself and encourage me to become bold and proactive regarding the accomplishing of objectives (Burgelman, 2015). I can evaluate myself to have a strong drive for achieving and an orienting for taking immediate accountability for the task and displaying of initiatives that are further in resonance with the controlling and planning of events in my organization. I also happen to have the drive of getting regular concrete feedback regarding the level of performance of individuals working under me along with my performance. I very well realize the significance of creativity as vital to the entrepreneurial concept. I happen to have a very good understanding of the fact that the sector of entrepreneurship is primarily dominated by the innovation and creativity. In order to have an effective launch in the market along with maintaining a high position in the market, it is very important to constantly innovate the services or products with renovating business strategies. I realize and have the potential to centralize creativity in my entrepreneurship. The desire for autonomy is very closely associated with the success in entrepreneurship as I definitely want to have proper control over my business, however, at the same time, I also have the understanding that entrepreneurship thrives under the work environment that has a sense of liberty and freedom (Demil, et al., 2015). I have a good potential of maintaining a balance between having proper and effective control on the business along with providing freedom and liberty of working styles for the employees. Regarding internal locus of control which is a very important dimension of entrepreneurship, I could evaluate myself to be a balanced individual with effective control of my business. I could gain high internal score regarding taking control of the environment in which I am or the environment of my business. I can very well assess myself to be seeking out innovative opportunities of business and acquiring required resources (Gallouj Gallouj, 2017). According to the findings of the survey, I could identify the areas where I need to develop in order to be successful as an entrepreneur. Belonging to a family where no family members have been involved in any kind of business and have always been an employee in many companies, I have a family programming of not being involved in taking risks. I need to develop the attitude and mental set up regarding taking risks and seeking out productive opportunities in uncertain environments. I have an environment of friends who have an innate ability and attitudes about taking risks. They have been a very encouraging and helpful for building up my confidence and attitudes towards taking risks in unknown territories (Hughes, et al., 2015). However, in my past endeavors regarding having my business, I had suffered fraudulent behaviors and faced many conflicting instances with many parties due to lack of experience as in-depth knowledge regarding the sector. However, at present, I have gained experience and conduct an in-depth analysis of the sector in which into which I desire of establishing my business. According to the assessment, I could comprehend that I have a very extraversion personality in context to the personality score. I need to have a great deal of social interaction in order to establish the business as provides me with a great deal of knowledge my business sector. I love to interact with people who have a diverse array of ideas and experience which also includes the potential customers, competitors, colleagues, customers, lawyers, coaches, suppliers, and accountants. I find myself to be very comfortable in being in most social situations. Having excellent communication style facilitates me in being a social person which further facilitates achieving effectiveness in business (Ketchen, Ireland Webb, 2014). I have the skills regarding the creativity and innovation about bringing new ideas about products and services which helps my team in designing and implementing the business ideas at a faster and much effective rate (Klein, et al., 2013). In that regards, I am definitely the Hipster which creates the idea regarding various services and products in the business venture. Third Personal Journal Entry Set To start a business, belief is the main thing that is required to address the problem and gives the significant solutions whatever the customer wants. Every large company has a humble story behind their success. All of the dignitaries start from nothing but just with the proper plan conviction, they have achieved everything. The history of the Lamborghini starts in the year 1963. The owner of the company Mr. Ferruccio Lamborghini, born in the year 1916, is the root cause of the entire foundation. The company has several phases of the extraordinary history that inspire the young minds of this generation. The time when he decided to build a factory full of luxurious sports cars at that time he was already in a wealthy state. During the period of the Second World War, he has started eth business by launching the tractor factory with full energy and dedication (Niskanen, Piispanen Montonen, 2017). This has created a major history and provides a reference to the industry. By the early sixties, he has already become a successful person and exactly knows what he really wants to do in his life. He always wanted to produce the best sports cars but never thought of this type of popularity in the recent scenario. According to many people, he is mad, but the reality is he is playing with his own dreams to change the trend of the world. After the construction of the cars, the company has become the most popular for producing the extravagance and unexplainable sports car in the world. The moment he decided was the perfect moment to create a tremendous history in the world (Obeng, Robson Haugh, 2014). The mission of the company is for those who love to possess the extraordinary and unusual objects, of high quality and cost. The objectives of the company are to describe the state of extreme, uncompromising, working with enthusiasm and Italian. The passion for transmitting the same brand with new styles and values that are characterized by unmistakable identity and combined with the best quality of materials is the target of the company. The "Collezione" is the best creation of the company which does not refer only to the fashion line but holds the entire "world of Lamborghini". Each collection of the company has the significant logo, attention to the details and high-quality materials. The vision of the company is to bring the spirit and passion of the Italy to the global market with new and distinct products that are inspired by the Italian arts and industrial design (Webb, Ireland Ketchen, 2014). The collections are not limited to cars; they have the stocks of watches, mobile, eyewear, accessories, leather goods, and furniture. The relationship between the employees and managers are quite healthy and acknowledged by every other company. The company has enthralled the enthusiasm of the mechanics as well as the engineers to increase the cutting-edge of the sports car that will always be able to stun the world at each new release. The production teams constantly grow in number and have played a strategic role within the company (Scaringella, 2017). The company mainly tries to achieve the success by beating every record and changing the passionate sense of the customers. The thing that I would love to emulate from the company is the innovative ideas that they are putting in each release. The elegant appeal towards the mechanics and considering them as of their level is something one should learn from them. The culture they have created is the best example to show the efficient production though team performance. Fifth Personal Journal Entry Set The story of the Lamborghini Company is quite inspiring and extraordinary. The thing that inspired me more is the innovative idea and the willpower of the Ferruccio Lamborghini, who instead of wasting and misusing the money and resources, used in a specific manner which was initially started by the tractor company. At the right time, he had decided to the resource to produce the world's best sports car which was considered as a mad idea of the people. Without responding to the views of the people, he has started the company with a clear vision. This shows the dedication of a person to fulfill his desires that are quite innovative and has the little chance of profit. Without thinking about the future success, he has started the company and still today, it is the most desirable sports car company across the world (Shirokova, Vega Sokolova, 2013). Mr. Ferruccio Lamborghini has inspired several young minds of the world that explains the best about life. He has changed the passion as well as the trend of the world in several phases of release. I have learned the best thing from him and that is" don't just live with your dreams, try to make it and then enjoy the dreams of success" (Simsek, Heavey Fox, 2017). According to his perspective "dreams like anything and people will call you crazy". This spirit will only change the shape, feeling, and tradition of a person. The company assures to provide the entire feeling of the Italy as it can't give the Italy exactly. The best part of the company that helps to increase the benefits is the team they have (Tavassoli, Bengtsson Karlsson, 2017). The teams are highly skilled with respect to the technology and cultural sense, works according to the need of the customers and changes in the society. They have the best coordination and team power to resolve the issues of the company. This makes fewer turnovers in the company which is the best part of it. An individual needs to be innovative rather than entrepreneurial. The creative ideas will lead to improving the entrepreneurial ideas of an individual (Wang, Thornhill De Castro, 2017). In the recent scenario, everyone is running for opening a new enterprise but hardly some of them get the success as they lack only in case of the creative ideas. The ideas will build a secure and efficient framework of the company that will lead to achieving the success within a few years. It is only about the ideas, but it is mainly about making it happen. Innovative ideas are the beginning of al fortunes. References Alvarez, S. A., Audretsch, D., Link, A. N. (2016). Advancing our understanding of theory in entrepreneurship.Strategic Entrepreneurship Journal,10(1), 3-4. Bjrnskov, C., Foss, N. (2013). How strategic entrepreneurship and the institutional context drive economic growth.Strategic Entrepreneurship Journal,7(1), 50-69. Burgelman, R. A. (2015). 24 Prigogines Theory of the Dynamics of Far-From-Equilibrium Systems: Application to Strategic Entrepreneurship and Innovation in Organizational Evolution.The Oxford Handbook of Creativity, Innovation, and Entrepreneurship, 433. Demil, B., Lecocq, X., Ricart, J. E., Zott, C. (2015). Introduction to the SEJ special issue on business models: business models within the domain of strategic entrepreneurship.Strategic Entrepreneurship Journal,9(1), 1-11. Gallouj, F., Gallouj, F. (2017). Knowledge Spillover-based Strategic Entrepreneurship.International Journal of Entrepreneurial Behavior Research,23(4), 726-730. Hughes, M., Hughes, P., Morgan, R. E., Hodgkinson, I. R. (2015). Organizing strategic entrepreneurship to enable product innovation in new and young technology-based firms. Ketchen, D. J., Ireland, R. D., Webb, J. W. (2014). Toward a research agenda for the informal economy: a survey of the Strategic Entrepreneurship Journal's editorial board.Strategic Entrepreneurship Journal,8(1), 95-100. Klein, P. G., Mahoney, J. T., McGahan, A. M., Pitelis, C. N. (2013). Capabilities and strategic entrepreneurship in public organizations.Strategic Entrepreneurship Journal,7(1), 70-91. Niskanen, J., Piispanen, V. V., Montonen, T. (2017). Business models for research-based spin-offs: the strategic entrepreneurship perspective.International Journal of Knowledge Management Studies,8(1-2), 38-53. Obeng, B. A., Robson, P., Haugh, H. (2014). Strategic entrepreneurship and small firm growth in Ghana.International Small Business Journal,32(5), 501-524. Scaringella, L. (2017). Book review: Knowledge spillover-based strategic entrepreneurship Joo J Ferreira, Leo-Paul Dana and Vanessa Ratten (eds). Shirokova, G., Vega, G., Sokolova, L. (2013). Performance of Russian SMEs: Exploration, exploitation and strategic entrepreneurship.Critical perspectives on international business,9(1/2), 173-203. Simsek, Z., Heavey, C., Fox, B. C. (2017). (Meta-) framing strategic entrepreneurship.Strategic Organization, 1476127017711720. Tavassoli, S., Bengtsson, L., Karlsson, C. (2017). Strategic entrepreneurship and knowledge spillovers: spatial and aspatial perspectives.International Entrepreneurship and Management Journal,13(1), 233-249. Wang, T., Thornhill, S., De Castro, J. O. (2017). Entrepreneurial orientation, legitimation, and new venture performance.Strategic Entrepreneurship Journal. Webb, J. W., Ireland, R. D., Ketchen, D. J. (2014). Toward a greater understanding of entrepreneurship and strategy in the informal economy.Strategic Entrepreneurship Journal,8(1), 1-15.