Business 616 Week 1

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BUS 616: International Business
Week 1 Assignment: Pfizer’s Drug Testing Strategy in Nigeria March 25, 2013

What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U.S. and Europe? “New medicines are developed through a series of controlled trials which assess the safety and efficacy of each new medicine by applying high scientific standards” (Pfizer.com). According to the information provided in Pfizer’s website the first step towards getting approval for the sale of an experimental drug is to the test the drug in laboratories that include animal testing. This stage is referred to “preclinical” testing after which clinical testing begins. These are the mentioned phases of development: Phase 1; This phase does not consider the efficacy of the experimental durg. Human subjects are administered low doses under the supervision of an investigator to determine the “safety and tolerability” of the experimental drug. Normally, healthy individuals take the drug in incremental amounts and researchers measure the participants physical response to the drug. Phase 2: This phase focuses on the effectiveness of the drug on a specific disease or condition. Side effects and potential resks are documented as well as adequate doses and the best method of delivery. Thousands of participants are selected from clinics and hospitals worldwide. Phase 3: Larger populations which could number in the thousands are tested once previous tests have proven successful. Participants nor physician-researchers know who has been administered the experimental drug, placebo or other medication. This is the “benefit-risk assessment” phase of the experimental drug. Registration: Once the drug and the experiments have been deemed successful, Pfizer must request permission for distribution. In the U.S. a New Drug Application (NDA) is filed with the Food and Drug Administration (FDA). In Europe a Market Authorization...
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