Showing 1 - 20 results of 20 for search '"United States."', query time: 1.70s Refine Results
  1. 1
    Studies in support of special populations, geriatrics.
    Published 1994
    Subjects: “...Drugs Testing United States....”
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    Government Document Conference Proceeding eBook
  2. 2
    Guidance for industry : M4E, the CTD, efficacy.
    Published 2001
    Subjects: “...Drug approval Government policy United States....”
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    Government Document Conference Proceeding eBook
  3. 3
    The extent of population exposure to assess clinical safety : for drugs intended for long-term treatment of of non-life threatening conditions.
    Published 1995
    Subjects: “...Drugs Dosage United States....”
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    Government Document Conference Proceeding eBook
  4. 4
    Guidance for industry : M2, eCTD specification, questions & answers and change requests.
    Published 2005
    Subjects: “...Document imaging systems United States....”
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    Government Document Conference Proceeding eBook
  5. 5
    Guidance for industry : M4Q, the CTD, quality.
    Published 2001
    Subjects: “...Drugs Quality control Government policy United States....”
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    Government Document Conference Proceeding eBook
  6. 6
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
    Subjects: “...Drug development Government policy United States....”
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    Government Document Conference Proceeding eBook
  7. 7
    Guidance for industry : Q3B(R2) impurities in new drug products.
    Published 2006
    Subjects: “...Drug development Government policy United States....”
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    Government Document Conference Proceeding eBook
  8. 8
    Clinical safety data management : definitions and standards for expedited reporting.
    Published 1995
    Subjects: “...Drugs Dosage United States....”
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    Government Document Conference Proceeding eBook
  9. 9
    Guidance for industry : M4S, the CTD, safety.
    Published 2001
    Subjects: “...Drug approval Government policy United States....”
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    Government Document Conference Proceeding eBook
  10. 10
    Guidance for industry : M4S, the CTD, safety appendices.
    Published 2001
    Subjects: “...Drug approval Government policy United States....”
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    Government Document Conference Proceeding eBook
  11. 11
    Guidance for industry : M4, organization of the CTD.
    Published 2001
    Subjects: “...Drug approval Government policy United States....”
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    Government Document Conference Proceeding eBook
  12. 12
    Guidance for industry : E 10 choice of control group and related issues in clinical trials.
    Published 2001
    Subjects: “...Clinical trials Government policy United States....”
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    Government Document Conference Proceeding eBook
  13. 13
    Guidance for industry : Q8(R2) pharmaceutical development.
    Published 2009
    Subjects: “...Drug development Government policy United States....”
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    Government Document Conference Proceeding eBook
  14. 14
    Guidance for industry M2 : eCTD specification : questions & answers and change requests.
    Published 2005
    Subjects: “...Document imaging systems Government policy United States....”
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    Government Document Conference Proceeding eBook
  15. 15
    Structure and content of clinical study reports.
    Published 1996
    Subjects: “...Clinical trials Reporting Government policy United States....”
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    Government Document Conference Proceeding eBook
  16. 16
    Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
    Published 1998
    Subjects: “...Pharmaceutical biotechnology United States....”
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    Government Document Conference Proceeding eBook
  17. 17
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
    Subjects: “...Drug approval United States....”
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    Government Document Conference Proceeding eBook
  18. 18
    Dose-response information to support drug registration.
    Published 1994
    Subjects: “...Drug approval United States....”
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    Government Document Conference Proceeding eBook
  19. 19
    Guidance for industry : E9 statistical principles for clinical trials.
    Published 1998
    Subjects: “...Clinical trials Statistical methods Government policy United States....”
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    Government Document Conference Proceeding eBook
  20. 20
    Guidance for industry : Q1B photostability testing of new drug substances and products.
    Published 1996
    Subjects: “...Drugs Testing Government policy United States....”
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    Government Document Conference Proceeding eBook
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