Clinical trials in INDIA- Legal issues By: Vallinadh Karamcheti Abstract: Clinical trials are conducted to ensure the safety and efficacy of the drug. They are conducted on the human subjects. Hence the clinical trials are liable to many legal aspects. Clinical trials are conducted in four phases. (Phase I‚ Phase II‚ Phase III‚ & Phase IV). All the phases of the clinical trials should comply with several legal aspects‚ as life of a person may be at risk if anything goes wrong with the clinical
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Presentation on: Pfizer and the Pharmaceutical Industry Fletcher Leung Analyst Investment Analysis Group February 15‚ 2002 Presentation Agenda • Industry Overview: Research Based Pharmaceuticals • Pfizer – Company Specifics – Performance – Growth Drivers • Valuation – Comparables Analysis – DCF • Recommendation February 15‚ 2002 Page 2 Investment Analysis Group 1 Industry Overview Economic •Cost Effective Demographic Sociocultural •Aging Population
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A potential problem for Pfizer Lipitor brand and their R&D activities‚ as well as their business in general‚ is the fact that Lipitor will soon lose its patent protection. The problem is that they do not have any suitable replacements for the revenue that will soon be lost due to the emergence of generic drugs following a branded drugs loss of patent protection. Their main source of revenue‚ Lipitor (sales of $10 billion last year)‚ will lose its patent protection in 2010. 4 Alternative/Suggested
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Antibacterial activity of allopathic medicine versus phytomedicine against Enterococcus faecalis: An in-vitro study. Abstract Background: A successful endodontic treatment depends on appropriate instrumentation‚ irrigation‚ decontamination and obturation. Decontamination of root canal plays a crucial role in the success of endodontic treatment. Therefore‚ a suitable medicament is essential which can effectively eliminate bacterial contamination. Aim and objectives: To investigate and compare the
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successful performance of Dr. Reddy’s can be described in 2 parts viz Pre FY 2000 Era and Post 2000 Era. Pre 2000 Era • Dr. Reddy’s formed a chemical based company named Dr. Reddy’s Laboratories to manufacture and supply active pharmaceutical ingredients to domestic drug companies by identifying a potential opportunity to do business in the chemical sector. This gave Dr. Reddy’s opportunities to popularize it s brand by formulating its own drugs to sustain in the highly competitive
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AIU Online Unit 4 IP December 4‚ 2011 Abstract A pharmaceutical company has rights to a drug paten but it takes a lot to get that patent. Until that can happen‚ anyone can make a similar drug and get it approved to sell on the market. Making sure the company acts in a proper way is important. When companies
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2 Operations Strategy in a Global Environment PowerPoint presentation to accompany Heizer and Render Operations Management‚ 10e Principles of Operations Management‚ 8e PowerPoint slides by Jeff Heyl © 2011 Pearson Education‚ Inc. publishing as Prentice Hall 2-1 Developing Missions and Strategies Mission statements tell an organization where it is going The Strategy tells the organization how to get there © 2011 Pearson Education‚ Inc. publishing as Prentice Hall 2-2
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1) What are the pros and cons of Abgenix’s collaborating with a partner on ABX-EGF? Before a new drug can be released to the market‚ it has to undergo a regulatory process. To complete the process‚ first the drug company (the sponsor in the process) has to submit information to prove that the drug is safe and effective. Pre-clinical data first has to be submitted before clinical trials can be conducted. After demonstrating the safety and efficacy of the drug through successful clinical trials
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Forecasting Denosumab Why is forecasting for any new drug so important? Why for Denosumab? Drug forecasting is a very important and essential process for any drug for multiple reasons: 1. Cost: The drug development is a lengthy and an expensive process. It will aid in the predevelopment process to identify future demand and to identify if it is a worthwhile venture. The future of a company could depend on the success or failure of a new drug in the market. 2. Profitability 3. Market
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com/reports/680564/ The Top Five Global Pharma Companies; Where they are Now and Where they heading? Description: A mini report identifying drivers and barriers to sustaining financial performance over the next 5 years for the top five global pharmaceutical companies -Johnson & Johnson‚ Pfizer‚ GSK‚ Novartis and Sanofi-Aventis This report presents the cases of the top five global pharma companies: J&J‚ Pfizer‚ GSK‚ Novartis and Sanofi-Aventis and identifies their key growth areas. Pooling data
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