Showing 1 - 20 results of 311 for search 'Center for Drug Evaluation and Research (U.S.)', query time: 0.27s Refine Results
  1. 1
    Manual del Centro para la Evaluacion e Investigacion de Farmacos.
    Published 2001
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document Book
  2. 2
    Quick index to general subjects of interest related to drug regulation.
    Published 1992
    “...Center for Drug Evaluation and Research (U.S.)...”
    Government Document Serial
  3. 3
    Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.
    Published 2003
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  4. 4
    Guidance for industry : format and content for the CMC section of an annual report.
    Published 1994
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  5. 5
    Guidance for industry : incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting.
    Published 2009
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  6. 6
    Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
    Published 2004
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  7. 7
    Guidance for industry : changes to an approved NDA or ANDA, questions and answers.
    Published 2001
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  8. 8
    Guidance for industry : drug master files for bulk antibiotic drug substances.
    Published 1999
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  9. 9
    Guidance for indusry : bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action.
    Published 2003
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  10. 10
    Guidance for industry : clozapine tables, in vivo bioequivalence and in vitro dissolution testing.
    Published 2005
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  11. 11
    Guidance : topical dermatologic corticosteroids, in vivo bioequivalence.
    Published 1995
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  12. 12
    Guidance for industry : dissolution testing of immediate release solid oral dosage forms.
    Published 1997
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  13. 13
    Guidance for industry : extended release oral dosage forms, development, evaluation, and application of in vitro/in vivo correlations.
    Published 1997
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  14. 14
    Guidance for industry : botanical drug products.
    Published 2004
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  15. 15
    Guidance for industry : statistical approaches to establishing bioequivalence.
    Published 2001
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  16. 16
    Guidance for industry : waiver of in vivo bioavailability studies for immediate-release soild oral dosage forms based on a biopharmaceutics classification system.
    Published 2000
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  17. 17
    Drug safety newsletter.
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document Journal
  18. 18
    Guidance for industry : liposome drug products, chemistry, manufacturing, and controls; human pharmacokinetics and bioavailablity; and labeling documentation.
    Published 2002
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  19. 19
    Guidance for industry : metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products; chemistry, manufacturing, and controls documentation.
    Published 1998
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
  20. 20
    Guidance for industry : nasal spray and inhalation solution, suspension, and spray drug products : chemistry, manufacturing, and controls documentation.
    Published 2002
    “...Center for Drug Evaluation and Research (U.S.)...”
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    Government Document eBook
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