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Clinical Research Resources
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FDA, Drug Discovery, GMP, GTP, and Pharmacogenomics

  1. Laws Enforced by the FDA and Related Statutes.
    http://www.fda.gov/opacom/laws/

  2. Comprehensive List of FDA Guidance Documents, including guidance to Conflict of Interest Disclosure.
    http://www.fda.gov/opacom/morechoices/industry/guidedc.htm

  3. Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals. Comments on the Proposed Rule for Good Tissue Practice for Manufacturers of Human and Tissue-Based Produts; Inspections and Enforcements.
    ICH: Guideline for god clinical practice
    GMP: Guide for active pharmaceutical ingredients
    http://www.fda.gov/cder/dmpq/cgmpnotes.htm

  4. Reporting Adverse Reactions and Medical Product Problems to the FDA.
    http://www.fda.gov/medwatch/how.htm

  5. National Drug Code Directory.
    http://www.fda.gov/cder/ndc/database/Default.htm

  6. Alphabetical list of all FDA links.
    http://www.fda.gov/opacom/hpchoice.html

  7. ClinicalTrials. Gov. provides regularly updated information about federally and privately supported clinical research in human volunteers.
    http://www.clinicaltrials.gov/

  8. Search for summaries and detailed monographs for drugs, disease, alternative medicine, toxicological managements, reproductive risks, and emergency care (RU only).
    http://lib2.rockefeller.edu/mdxcgi/mdxhtml.exe?&tmpl=mdxhome.tm1&SCRNAME=mdxhome&CTL=/mdx94/mdx/mdxcgi/megat.sys

  9. Drug Discovery Online (industry professional)
    http://www.drugdiscoveryonline.com/IndustrySearch/SearchResults.aspx?keyword=Pharmacology&ATC~C=001+S=001+R=001+L=a

  10. Pharmacogenomics: definitions, news.
    http://www.ornl.gov/sci/techresources/Human_Genome/medicine/pharma.shtml

  11. Pharmacogenetics: definitions, news.
    http://www.dartmouth.edu/~dmsheart/genetics/pharm/pharm.html





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