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Review for Test 1

Review for Test 1 - Santhosh Varadarajan CHE 597 Review for...

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Santhosh Varadarajan CHE 597 Review for Exam 1 10/19/2009 1. (8/27) Industry Overview: World Market, Basic Economics, Costs a. Innovations in the 20 th Century i. Life saving - anti-infective (penicillin), oncology products ii. Life Sustaining – hypertension, HIV iii. Medicine reducing need for surgery – anti-ulcerants iv. Quality of life – anti-depressants v. Vaccines – MMR, polio vi. Human Genome Project b. Drug Delivery i. Drug is swallowed, and then enters the stomach followed by the G.I. Tract. It is then transported to the blood stream via the hepatic portal vein. It is then metabolized in the liver followed by the heart and the brain. It then enters the kidney for urinary excretion. Finally the drug is excreted after going through the entire G.I. Tract. ii. Impact on Pharmaceuticals 1. Potential for faster and more accurate diagnosis 2. Potential to use more specific/tailored drugs 3. Fundamental changes in manufacturing c. Ethical and Societal i. Society wants improved health care but not the costs ii. Ethical issues on use and storage of genomic information iii. Development of drugs for specific genotypes d. Healthcare Industry & Pharmaceutical Companies i. Discovery and development of new medicines 1. Unmet medical need reduced 2. Treatments for disease with great tolls 3. Longer and better lives ii. Increasing impact on social costs, and presence in media iii. Unique Industry 1. Cannot sell product without regulatory approval 2. Strict governmental regulatory control on manufacturing 3. Must produce high quality product 4. Limited product lifetime iv. Highlights of industry 1. NA, EU, Japan account for 88% of pharma sales 2. Chinese market growing at a rate of 28% to $10 billion 3. Generics sales are up by 10.8% since 2003 v. U.S. Highlights 1. Cholesterol reducers are top therapeutic class and is 6.6% of market
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2. Mail order is fastest growing channel of market 3. Lipitor is the largest selling product and Pfizer is largest company 4. Teva is leading generic company e. Research i. Pharma industry accounts for 18.7% of most research-intensive companies ii. American pharma companies lead the world in research expenditure at 53% f. Product life cycles i. American pharma sales peak higher in sales but in the long run they sell for less than European medicines. This is because Europe charges more for generics so the sales don’t peak as high, but the sales also do not drop as much when the patent ends and the generics come out. g. Definitions i. A generic drug is a copy that is the same as a brand-name drug in dosage, safety, how it is taken, quality, performance and intended use h. Patent Protection i. The ANDA process does not require the drug sponsor to repeat costly animal and clinical studies on ingredients or dosage forms already approved for safety and effectiveness.
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Review for Test 1 - Santhosh Varadarajan CHE 597 Review for...

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