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.
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.
