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MIMM 387 Lecture : feb 27 2012.docx

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School
McGill University
Department
Microbiology and Immun (Sci)
Course
MIMM 387
Professor
Robert Murgita

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Document Summary

Missing an enzyme responsible for the breakdown of lipids. One complication is a severely enlarged spleen and liver. This was a success story but not all of them are. Research scientists play the largest role in the preclinical research phase. Ind = investigational new drug application (permission to start a clinical trial). Even after a drug is accepted, there are still more tests to be done/regulation. You must regulate the drug in the population, because sometimes things come up that were not seen in trials. 1/10 drugs that begin in the preclinical stage end up being approved. (2) Basically 10 years to get a drug approved, and a 1. 3 billion dollar cost. A lot of drugs do not make it past phase i/ii. Sometimes, when you decide to invest in phase iii, the drug will fail. Defect in transport of na and cl across epithelium.

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Related Questions

Evaluate the research policies of the National Institutes of Health (NIH, http://health.nih.gov/).

1. In your own words, explain the mission of the NIH? What goals are in place to assure that the NIH achieves this mission?

2. The grant planning and writing process can be very long and stressful. Outline the NIH grant application process from the planning stage through the post-award management phase.

3. List and describe the four key components the NIH is looking for when they fund research projects.

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5. Summarize the most recent NIH policy on the inclusion of women and minorities as subjects in clinical research. Explain why this policy is necessary.

Please help me with these questions. Imagine that you are a newly hired assistant professor at a teaching university and you wish to conduct a clinical trial examining the vaccine efficacy of a new, FDA-approved Ebola vaccine. You will be examining the immunological response in your study participants. Discuss the steps you would take as the principle investigator to get your study started, and address the following questions: What paperwork would need to be submitted? What boards or committees would you need to seek review and approval through? What are some of the regulatory requirements for your study you would need to prepare and provide for? Note: For this discussion, assume the vaccine has been through FDA trials and is approved for use in the general population: normal, healthy adults ages 18–65.

please need help in this :(((((

Go to:http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm364750.htm,Give a very brief background on why the Orphan Drugs Act cameabout., Go to:http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm ,In the box for "Orphan Designation", type "disease". In the "Sortresults", pull down to show "Most Recent to Earliest". In the"Records per Page", choose 50. Press "Search". "Pick one drug thatis approved or designated as an orphan drug after the year 2000whose row number is the same as the last 2 digitsis of your studentnumber.which is 07 , Go to Pubmed and find references on the drugand/or indication (disorder) and discuss the rare disease orcondition for which the drug is being or will be investigated, theproposed use of the drug, and the reasons why such therapy isneeded. ,, Provide a description of the drug, and include theidentity of the active moiety if it is a drug composed of smallmolecules, or of the principal molecular structural features if itis composed of macromolecules; its physical and chemicalproperties, if they are available ,,,Discuss the scientificrationale or a medically plausible basis for the use of the drugfor the rare disease or condition, including all relevant data fromin vitro laboratory studies, preclinical efficacy studies conductedin an animal model for the human disease or condition, and clinicalexperience with the drug in the rare disease or condition, ifavailable. ,,, If there are no good articles available in PubMedabout your drug or disease, pick another drug to work on.