Search Results - Center for Drugs and Biologics (U.S.)

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  1. 1
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    Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances /

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  2. 2
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    Guideline for submitting documentation for the manufacture of and controls for drug products.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  3. 3
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    Guideline for the submission in microfiche of the archival copy of an application.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
    Government Document Book

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  4. 4
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    Forskolin : its biological and chemical properties / by Seamon, Kenneth B.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
    Government Document Book

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  5. 5
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    Guideline for the format and content of the summary for new drug and antibiotic applications.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  6. 6
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    Guideline on formatting, assembling, and submitting new drug and antibiotic applications.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  7. 7
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    Guideline for the format and content of the human pharmacokinetics and bioavailability section of an application.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  8. 8
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    Guideline for submitting documentation for the stability of human drugs and biologics.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
    Government Document Book

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  9. 9
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    Guideline for submitting samples and analytical data for methods validation.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  10. 10
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    Guideline for submitting documentation for packaging for human drugs and biologics /

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  11. 11
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    Guideline for the format and content of the chemistry, manufacturing, and controls section of an application.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  12. 12
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    Guideline for the format and content of the microbiology section of an application.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
    Government Document Book

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  13. 13
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    Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application.

    Published 1987
    “…Center for Drugs and Biologics (U.S.)…”
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  14. 14
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    Compliance program reference : otc drug monograph implementation (compliance program #7361.003)

    Published 1985
    “…Center for Drugs and Biologics (U.S.)…”
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  15. 15
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    Compliance program reference : inspections of licensed and unlicensed blood banks (compliance program #7342.001) and inspections of source plasma establishments (compliance program...

    Published 1985
    “…Center for Drugs and Biologics (U.S.)…”
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  16. 16
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    Approved drug products with therapeutic equivalence evaluations.

    Published 1985
    “…Center for Drugs and Biologics (U.S.)…”
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    Government Document Microfilm Journal

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  17. 17
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    Center for Drugs and Biologics Medical Library.

    Published 1987
    “…Center for Drugs and Biologics (U.S.). Medical Library…”
    Government Document Book

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  18. 18
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    Center for Drugs and Biologics Medical Library.

    Published 1985
    “…Center for Drugs and Biologics (U.S.). Medical Library…”
    Government Document Book

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  19. 19
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    Center for Drugs and Biologics Medical Library.

    Published 1985
    “…Center for Drugs and Biologics (U.S.). Medical Library…”
    Government Document Book

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  20. 20
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    DRLS : drug establishment registration and drug listing instruction booklet.

    Published 1986
    “…Center for Drugs and Biologics (U.S.). Drug Listing Branch…”
    Government Document Book

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