Showing 1 - 20 results of 430 for search '[Center for Drug Evaluation and Research],', query time: 0.27s Refine Results
  1. 1
    The CDER reference guide.
    “...Center for Drug Evaluation and Research....”
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    Government Document Database
  2. 2
    Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions.
    Published 2008
    “...[Center for Drug Evaluation and Research],...”
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    Government Document eBook
  3. 3
    Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions.
    Published 2008
    “...[Center for Drug Evaluation and Research],...”
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    Government Document eBook
  4. 4
    Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions.
    Published 2008
    “...[Center for Drug Evaluation and Research],...”
    Get full text
    Government Document eBook
  5. 5
    Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions.
    Published 2008
    “...[Center for Drug Evaluation and Research],...”
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    Government Document eBook
  6. 6
    Reviewer guidance : validation of chromatographic methods.
    Published 1994
    “...Center for Drug Evaluation and Research,...”
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    Government Document eBook
  7. 7
    Guidance for industry : immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation.
    Published 1995
    “...Center for Drug Evaluation and Research,...”
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    Government Document eBook
  8. 8
    Guidance for industry : single dose acute toxicity testing for pharmaceuticals.
    Published 1996
    “...Center for Drug Evaluation and Research,...”
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    Government Document eBook
  9. 9
    Guidance for industry : format and content for the CMC section of an annual report.
    Published 1994
    “...Center for Drug Evaluation and Research,...”
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    Government Document eBook
  10. 10
    Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
    Published 1995
    “...Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,...”
    URL accesses index of CDER guidance documents, from which a link may be made to the title desired
    Government Document Microform Book
  11. 11
    Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility.
    Published 1996
    “...[Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research],...”
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    Government Document Conference Proceeding eBook
  12. 12
    Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.
    Published 2005
    “...[Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research],...”
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    Government Document Conference Proceeding eBook
  13. 13
    Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
    Published 1995
    “...Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,...”
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    Government Document eBook
  14. 14
    Annual report.
    Published 2004
    “...Center for Drug Evaluation and Research, Food and Drug Administration,...”
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    Government Document Serial
  15. 15
    Drug safety newsletter.
    “...Food and Drug Administration, Center for Drug Evaluation and Research....”
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    Government Document Journal
  16. 16
    Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products.
    Published 1996
    “...U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug...”
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    Government Document eBook
  17. 17
    Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products.
    Published 1994
    “...Center for Drug Evaluation and Research : Center for Veterinary Medicine,...”
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    Government Document eBook
  18. 18
    From test tube to patient : improving health through human drugs /
    Published 1999
    “...U.S. Food and Drug Administration, Center for Drug Evaluation and Research,...”
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    Adobe Acrobat reader required
    Government Document Book
  19. 19
    Drugs@FDA.
    “...U.S. Food and Drug Administration, Center for Drug and Evaluation Research....”
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    Government Document eBook
  20. 20
    PHS guideline on infectious disease issues in xenotransplantation.
    Published 2001
    “...Food and Drug Administration, Center for Biologics Evaluation and Research,...”
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    Government Document eBook
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