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Outline the stages involved in research, development and testing of new pharmaceutical products

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Introduction

´╗┐Emina 1. Outline the stages involved in research, development and testing of new pharmaceutical products. Within the outline include potential costs and a general time frame for the process. AstraZeneca They have spent $12 billion for every drug they got approval for. Discovery phase -4years 1. The pharmacy will try to discover potential medicine. They will first identify the unmet medical need and the market opportunity, find a potential medicine through laboratory research, that is potent, selective and absorbed into and safe in the body. Begin the process of seeking patent protection for the potential medicine. The pharmacy will also collaborate with academia and external clinicians to access the best external science and medial opinion. ...read more.

Middle

2. Phase 2 studies- Studies in small groups of patients to evaluate effectiveness of the medicine. 3. Phase 3 studies- Studies in a larger group, looking at larger samples. They gather information about effectiveness and safety of the medicine and evaluate the overall benefit and risk of the medicine. In this phase they create branding for the new medicine. They prepare the medicine so that they can be released to patients. 4. Phase 4 ? The pharmacy will now have to submit a regulatory submission to get approval from regulatory authorities to market and sell the medicine. Post- launch and delivering to the patients ? 9years 1. Releasing it in the market, bringing awareness of the new medicine 2. ...read more.

Conclusion

unexplained muscle pain, tenderness, or weakness; 2. fever, unusual tiredness, and dark colored urine; 3. swelling, weight gain, urinating less than usual or not at all; or 4. nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Less major side effects 1. headache, depressed mood; 2. mild muscle pain; 3. joint pain; 4. sleep problems (insomnia), nightmares; 5. constipation; 6. mild nausea; or 7. stomach pain or indigestion. 3. How long is a patent valid on this drug or medicine (specify the country)? 4. Should economics be the deciding factor in access and distribution of drugs (are drugs like any other commodity or are they somehow different)? 5. For what purpose was the drug Thalidomide (Contergan) used? What problems arose with its use? What problems does this identify with the R & D of drugs? ...read more.

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