Different Applications For Small And Large Molecules

Q.1 Compare and contrast NDA and BLA. Why are there different applications for small and large molecules? A small molecule drug approval required a New Drug Application (NDA) because it covered under Federal Food Drug and cosmetic Act Section 505 while large molecule drug required a Biologics License Application (BLA) because it covered under Public Health Service Act Section 351. Compared with conventional small-molecule drugs, products derived from a biological source are structurally complex, large molecules and involved in different manufacturing processes that require tight control to ensure their safety, purity, quality, and efficacy. Because of these differences in respect of the product characteristics and manufacturing process,†¦show more content†¦The regulations regarding BLAs for therapeutic biological products included in 21 CFR parts 600, 601 and 610. Form 356h is a harmonized form, and a sponsor can use it for NDA, BLA and Abbreviated New Drug Application (ANDA). Drugs are nominated as orphan drugs for those diseases with patient population of less than 200,000 in the US. The FDA has given special provision for the development, marketing approval and marketing of orphan drugs under 21 CFR Part 316.The Orphan Drug Act provides incentives to organizations to research and test drugs because it have limited commercial returns due to the small size of the patient group. Companies are taking commercial risks so FDA is providing assistance in the forms of NDA fee waivers, tax credits for clinical research, and grants for the research. The FDA also provides market monopoly to the organization to market the drug for seven years. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups. The Orphan Grants Program from FDA has been used to bring more than 45 products in the market. 21CFR 316 gives FDA right to revoke orp han drug designation if they found that untrue statement regarding material fact or drug is not eligible as an orphan drug and withdraw marketing monopoly.

Mary Shelley s The Human Person - 1533 Words

Through the novel Frankenstein, Mary Shelley delves into ethical and deontological issues concerning the sciences and scientific research – themes that are actually still current in today’s day. Mary Shelley exalts the human person, questioning many truths of the world and what it means to be human, along with all the implications that come with it. The novel also explores the theme of nature versus nurture, keeping in mind the knowledge and concepts of the time period it was written in, while continuing to relate to ideas of today’s day and age. In the novel, paralleling with the society at the time, prejudice exists, people are judged, those deemed different are badly treated by humanity. And, over the years people increasingly begun to realize that the environment in which individuals grow up in and all the experiences during their life shape them into the person they are. And, depending on those factors, different people will have different character traits a nd temperaments, this isn’t any different in Shelley’s novel. Frankenstein s monster was taught to be malevolent through Victor s abandonment and further negligence as well as society s exclusion rather than innately being that way, since he didn t have any guidance in his pursuit of knowledge. Victor Frankenstein, driven by his curiosity and desire for scientific glory, discovers the secret of life after many years of study in seclusion. Upon his discovery, he creates a being out of body parts he has carefullyShow MoreRelatedMary Shelley s Life And Life1153 Words   |  5 PagesMary Shelley, through all of her struggles, still manages to completely entrap the entire imagination, and emotion of each individual member of her audience. Shelley, maiden name Godwin, was born on the 30 of August, 1797. Shortly after giving birth to to her newborn child, Mary Wollstonecraft died of an illness. 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In the beginning of the story, the audience receives Captain Walto n s point of view, who primarily writes letters to his sister Margaret Saville, in England. Secondly, the audience comes hand in hand with Victor Frankenstein s point of view and within his narrative, they receive the indomitable Creature s point of view. The major theme portrayedRead MoreFrankenstein: Allusions1112 Words   |  5 Pagesis a reference to a well-known person, place, event, or literary work. These allusions are typically used by an author who intends to make a powerful point without the need to explain it. Mary Shelley s Frankenstein provides many examples of allusion s. She connects the story of â€Å"Prometheus†, Coleridge s Rime of the Ancient Mariner, and Milton s Paradise Lost to her own novel to convey the critical points of the meaning behind the story. Not only does Mary Shelley make use of the mythological symbolismRead MoreMary Shelley s Frankenstein And The Human Nature1029 Words   |  5 PagesThere are many places in Mary Shelley’s book Fr ankenstein that refer to the human nature; different components of it is represented through almost every character. For instance, Elizabeth possibly epitomizes the benevolence, compassion, and empathy of humanity. Other characters symbolize aspects as well; Victor is curiosity and obsession, Henry is adventure and creativity, Caroline is selflessness and love, etc. My personal favorite, however, is the creature that was created by Victor FrankensteinRead MoreAnalysis Of Mary Shelley s Frankenstein 1117 Words   |  5 Pages Intro One rainy night in Austria the idea of the to be famous novel, Frankenstein came to Mary shelly in a dream. The idea to write a ghost story was not her own but Lord Byrons , a friend who was also summer sojourning with Mary and her husband Percy Shelley. Mary Shelley was 16 at the time and The story of Frankenstein was then published two years later in 1818. The tale takes place somewhere in the 18th century a time rich with romantic movement ideas, french revolution aftermath, gothicRead MoreMary Shelley s Use Of Point Of View1467 Words   |  6 PagesMichael Ginyard Mrs. Joyner English IV Honors 17 December 2015 Mary Shelley’s Use of Point of View Mary Shelley uses point of view in Frankenstein to naturally develop her reader’s opinions and feelings in regards to her characters. Shelley forms her own Chinese Box structure along with a frame narrative stirred together to give the nature of stories within stories in a completely unique way (Narrative Technique in Frankenstein). When Shelley’s readers interpret Frankenstein, they tend to have

It Is Never Too Late To Quit Smoking. Smoking Is A Habit

It is never too late to quit smoking. Smoking is a habit that many Americans have even into their old age. However, smoking is not a healthy habit it effects your brain, heart, lungs and throat, it can cause cancer, as well as COPD. Not only does smoking lead to chronic diseases, but has many effects on the aging process. In older adults, they see a lower quality of life due to a lifelong of smoking. Although smoking in old age has become less popular, the generation of baby boomers is going to change that statistic and will need services for cessation. It is never too late to quit; the benefits of quitting are almost instant. Smoking has adverse effects no matter how old you are, but in old age it makes the normal aging process much†¦show more content†¦Although the effects smoking has on a person’s appearance is not a typical health concern, it is an easy way to see the effects smoking can have on the body. Smoking brings many concerns no matter a person’s ag e. However, for the population of older adults that chooses to smoke, there are more immediate concerns with their health. For many older adults, aging brings with it disease, cognitive loss, and many other issues, but smoking only speed up the symptoms and often makes them worse. Smoking can influence older adult’s medications; it can complicate a previously diagnosed illness; and smoking can add more health issues on top of already diagnosed diseases. Smoking brings concerns for elderly smokers because it is dangerous to their health, especially for those that have preexisting health conditions like, cancer, cardiovascular disease and others (Center). Smoking in old age will only make disease treatments less effective and unlikely to cure. Although there has been an increased smoking cessation among the elderly, with the baby boomer population aging there is likely to be an increased need for it. 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Starbucks Going Global Fast Case Study Answers - Free Sample Solution

Question: Discuss about theStrategic Analysis of Myer. Answer: Introduction Myer is a retail group that was started by a Russian immigrant, Sydney Myer, together with his brother, Elcon Myer in Bendigo, 1900. In 1914, Myer built the largest chain of departmental store in Melbourne, which is currently the CBD store of the organization. The ownership has changed over time after the death of its founder, Sydney Myer. Myer has grown due to the continuous development of new stores across the Six Australian states. It has also acquired other departmental stores such as Grace Bros in 1983, Boans Ltd, Western stores in South Wales and Farmers Co. Myer Emporium merged with GJ Coles Coy to form Coles Myer, which was later sold in 2006 (Myer, 2017). The main products include womens, mens, and childrens wear, beauty fragrance and cosmetics, home wares, electrical goods, intimate apparel, toys, footwear, handbags and accessories and general merchandise. The new owners of Myer include; TPG/New Bridge, the Myer family and the Myer current management team, where Richard U mbers is the CEO. It became a private ownership after divesting from Coles Myer. The mission of Myer is to provide customers and the community at large with the highest standard of service and ensure that they consistently meet and exceed customers shopping expectations. Their vision entails becoming an international-class retail business aimed at inspiring everyone. It focuses on style and fashion by providing quality products, friendly services and additional benefits such as MYER One Loyalty Program. As per 2016 annual reports of the retail group, Myer recorded revenue of $3.3billion, operating income of $113.5billion and net income $60.5billion (IBISWorld, 2017). They have approximately over 12500 employees, along with 1200 suppliers and 54000 shareholders. It has 67 stores located across Australia. Their main competitors include David Jones, Harris Scarfe, Kmart Australia, and Target Australia. Major markets are New South Wales, Queensland, and Queensland. Macro-Environment Analysis using PESTEL Analytical Framework Political Factors Political stability in the region encourages more investors and suppliers to carry out business, thus, recording high rates of return and low risks of business failure (Bill, 2011). The government focus on expanding international trade provides an excellent opportunity to retailers to get suppliers and customers from across the world using E-retailing (ASX Media Release, 2016). The chairman of Myer has highlighted (during the released of the annual report) political factors that affect Myer. One of which is the uncertainty of political level, such as new taxes and charges (carbon tax and flood levy) would affect consumer spending, thus lowering revenue of the firm. Other concerns such as loopholes in goods service tax (GST) legislation and the new setup of the industrial relations, would negatively impact the performance of Myer. Economic Factors Fluctuation of the Australian dollar and global economy weaknesses adversely affect the sales growth of the retail industry. Economic factors such as falling house prices, high oil prices, low rate of saving and the decreasing GDP negatively affect the consumer confidence and spending patterns (Barney and Hesterly, 2008). However, the decrease in the unemployment and inflation rates, positively influence the success of the retail business. Socio-Cultural Factors The increased preference for high-quality products among the Australians provides a greater opportunity for retailers like Myer to focus on customer satisfaction to gain a competitive advantage (Glynis, 2015). The population is culturally diverse, and therefore the retail industry should manage diversity through the provision of a wide range of products to meet the needs and expectations of the customers. Technological Factors International competitiveness of Australian retail industry is as a result of the use of the internet and e-retailing (Sharrieff, 2012). The new communication technologies accelerate expansion into new foreign markets globally. The fiber optic, mobile network and satellite coverage have led to connections with various activities thus improving efficiency (Myer, 2014). The Federal Government has established policies that help inventors commercialize and protect their new entrepreneurial ideas. Legal Factors Taxation policies and employee regulation have been affecting the industry. Laws such as compliance with disclosure requirements, health and safety regulations, and consumer protection influence the retail business either positively or negatively. When opening new stores, the concerned government should approve so as to control illegal activities in Australia (Hanson et al., 2008). Environmental/ Ecological Factors Australia is a dry continent with least amount of water and human activities affect the marine environments. Selecting an environment that is conducive to targeted customers is a great challenge to Myer retail store. Climate changes, private and public environmental programs are factors that affect the industry. Recycling of waste products improves business sustainability in the retail sector (BNET Business Directory, 2007). In conclusion, using the PESTEL analysis, the following opportunities are available to Myer; increased disposable income, expanded international trade agreements, increased preference for high-quality products by customers, automation in business and use of knowledge management systems (Gillespie, 2007). Besides, mobile technology and information security regulation aid in formulating effective strategies. The threats include; unpredictable government spending increased the cost of capital, economic recessions, new taxes and charges, online disruptions and rose in the wealth gap. Industry Analysis using Porters Five Forces Threats of New Entrants This risk is high in the retail industry due to its promising nature and the large population which increases demand. There are a decreased number of retailers who are independent because of the competition. It is not easy for the small-scale retailers to enter the market because large companies, such as Myer, enjoy economies of scale (ASX Media Release, 2016). The industry turnover is high therefore it attracts more competitors. The increased customer loyalty to specific brands like those of Myer is also a threat to new entrants. Threat of Substitutes-High The threat of substitute products is high. Several companies offer a variety of trendy and fashionable products, therefore increasing the availability of substitute products. They focus on both national and home brands and offer low prices to the substitute products (ASX Media Release, 2012). Increased use of new technologies leads to innovation of substitutes with greater quality and performance. Product differentiation by Myer Company can be its best strategy to maintain its competitive advantage. Bargaining Power of Suppliers This force is low in the retail industry. For the vendors to compete, they have to decrease costs of the firms and improve product quality. Myer, being a large retailer, focuses on improving efficiency and reducing overall costs (Eli, 2008). Such strategy lowers the bargaining power of suppliers. Besides, the presence of wide range of substitute inputs and a higher concentration of vendors significantly impact their bargaining power. Bargaining Power of Customers Buyers bargain for quality products and services at low costs. There are no switching costs that customers can incur when they want to move to other retailing company if they dont get the styles and fashions in a particular shopping or retail mall (ASX Media Release, 2012). Although there is an increased number of existing and potential in the industry, departmental stores such as Myer cannot raise prices since the firm concentration is high and therefore, customers can switch to other alternatives. If Myer offers unique products, then it can gain a competitive advantage. Industry Rivalry Most of the departmental stores in the retail industry are almost equally balanced like Myer and its main competitor, David Jones (Lynch, 2014). They use competitive pricing policies to show customers that they offer high-quality products. Product differentiation is difficult. Thus, imitation is not easy. Competitive rivalry is high as the retailers want to have a full market share. The acquisitions and merging is a trend that focuses on increasing the competitiveness of the stores in the industry. Based on the Porters Five Forces Model, we can draw the following conclusion. In the retail industry, the barriers to entry into the market are high; the consumer bargaining power is moderate because of the concentration of major retailers in the region (Porter, 2008). Internal Analysis to Identify Resources and Competencies of Myer VRIO Framework Prime and strategic locations; Myer has located all its stores in high traffic places across the Australian states which give them an opportunity to have more potential customers. They have brand recognition both domestic and internationally. It has achieved such brand equity through merchandising and licensing its overall products (ASX and Media Releases, 2015). The aesthetic appeal of the departmental store; Myer has repositioned its stores to appeal to customers, thus creating an excellent customer experience, improved profitability, and a high competitive advantage. The large size and continental presence enable Myer to enjoy large economies of scale and low costs of inputs from suppliers. Customer loyalty based programs, such as Myer One, Myer Visa Card (Zappone, 2012) and Myer gift card (Simon, 2007) increases the frequency of customer loyalty holders to shop in the stores. They have maintained a good corporate social responsibility by building goodwill and taking better initiatives that enhance the communitys well-being. They are strategic capabilities because almost all of them are valuable as they allow Myer to exploit opportunities and reduce threats to the macro environment fully. The resources and competencies are rare as few competitors possess them. They are also costly to imitate by other firms, especially small-scale retailers. Lastly, they are non-substitutable as there are no strategic equivalents in the industry (Hunger Wheelan, 2007). Conclusion In summary, strategic analysis of the Myer departmental stores leads to the identification of key opportunities and threats and also determining its competitiveness in the retail industry. The clothing and cosmetic products of Myer have recorded satisfactory performance over the years, and therefore they should improve on their marketing strategies by targeting global presence and adequate use of the areas in the showrooms. Also, tying up with foreign players and exploring innovative promotional strategies. References ASX Media Release, (2016)Myer Holdings Limited 2016 Annual Report and Notice of Annual General Meeting (online) Retrieved on 13 February 2017 https://investor.myer.com.au/FormBuilder/_Resource/_module/dGngnzELxUikQxL5gb1cgA/file/Myer_Annual_Report_2016.pdf ASX and Media Releases, (2015) Myer Holdings Limited 2015 Annual Report and Notice of Annual General Meeting (online) Retrieved on 13 February 2017 https://www.annualreports.com/HostedData/AnnualReports/PDF/ASX_MYR_2015.pdf ASX Media Release (2012) Myer Full Year Results ending28 July 2012 (online) Retrieved on 15 February 2017 https://investor.myer.com.au/FormBuilder/_Resource/_module/dGngnzELxUikQxL5gb1cgA/file/Myer_Full_Year_Results_(FY2012)_Release_and_Presentation.pdf Barney, B., and Hesterly, S., (2008) Strategic Management and Competitive Advantage: VRIO Internal Analysis Evaluating a firms internal capabilities: 2nd Edition. P. 72-107. Bill S. (2011). Economic Structure and Performance of the Australian Retail Industry; Productivity commission inquiry report. https://www.pc.gov.au/inquiries/completed/retail-industry/report/retail-industry.pdf BNET Business Directory (2007). Strategic Analysis (online) Accessed on 24 February 2017 https://www.cimaglobal.com/Documents/ImportedDocuments/cid_tg_strategic_analysis_tools_nov07.pdf.pdf Eli G., (2008). Australian Financial Review "Myer sees slow spending recovery" Retrieved on 22nd Feb 2017 from https://www.highbeam.com/doc/1G1-201948275.html Gillespie, A. (2007). Foundations of Economics: PESTEL analysis of the macro-environment Oxford University Press, Retrieved on 24th Feb 2017 from https://www.kantakji.com/media/1610/ty3.pdf Glynis T. (2015). The Australian Business Review. Myers brands new retail strategy to tackle rivals (online) Accessed on 15 Feb 17 https://www.theaustralian.com.au/business/companies/myers-brands-new-retail-strategy-to-tackle-rivals/news-story/17f723bbf84ed73d3d0292e8f375d329 Hanson, D., Dowling, P. J., Hitt, M. A., Ireland, R. D. and Hoskisson, R. E. (2008). Strategic Management: Competitiveness Globalization. The Internal and External environment Analysis; (book) 3rd Ed. South Melbourne, Vic.: Thomson Learning Australia. Innovation and Technology: Australia. P. 45-120. Hunger, J. D., Wheelan, T. L. (2007). Strategic Management and Business Policy: Environmental scanning and industry analysis (book) 13th edition Pearson Education, Prentice hall p. 94-136. IBISWorld, (2017). Departmental stores in Australia, Market research report. Retrieved on 24th Feb 2017 from https://www.ibisworld.com.au/industry/department-stores.html Lynch, J. (2014) Myer and David Jones Merger: cautious approval but doubts remain" (online) Accessed on 20 Feb 17 https://www.smh.com.au/business/myer-and-david-jones-merger-cautious-approval-but doubts-remain-20140203-31wb9.html Myer Media Release (2014), New season lifestyle collections at Myer https://www.myer.com.au/resources/7bb661d0-4d1d-44bc-a295-27a4ffde0ebb/2014_new_brands_for_the_home_fv.pdf Myers (2017)Company Information (online) Accessed on 12 Feb 17 https://www.myer.com.au/p/about-myer/the-company/about-us/ Porter, M. E. (2008) "The Five Competitive Forces That Shape Strategy."Special Issue on HBS Centennial:Harvard Business Review, P. 7893. https://www.hbs.edu/faculty/Pages/item.aspx?num=34522 Sharrieff, M. (2012). How to write a strategic analysis for business organizations online accessed: 22nd Feb 2017. https://smallbusiness.chron.com/write-strategic-analysis-business-organizations-89.html Simon E. (2007). Australian Financial Review."Myer uses Visa card to generate loyalty" retrieved from https://www.highbeam.com/doc/1G1-171092628.html Zappone, C. (2012) Myers Inks Card Deal as Battle for Shoppers Heats Up (online) Accessed on 20 Feb 17 https://www.smh.com.au/business/myer-inks-card-deal-as-battle-for-shoppers-heats-up-20121102-28o6r.html