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  1. 1
    Gene therapy product development : a primer for regulatory affairs professionals

    Gene therapy product development : a primer for regulatory affairs professionals by Rappoli, Bethany L.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  2. 2
    Is FDA's approval process moving too fast?

    Is FDA's approval process moving too fast? by Hymes, David J.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  3. 3
    Device / biologic combination products

    Device / biologic combination products by Mahon, Barbara Ann Kurilla

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  4. 4
    Standardization of the prescription label to increase patient safety

    Standardization of the prescription label to increase patient safety by King, Brenda P.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  5. 5
    Issues of materiality in informed consent

    Issues of materiality in informed consent by Vermette, Jennifer

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  6. 6
    For better or for worse : how the Dietary Supplement Health and Education Act (DSHEA) changed the dietary supplement industry and the regulatory industry

    For better or for worse : how the Dietary Supplement Health and Education Act (DSHEA) changed the dietary supplement industry and the regulatory industry by Lafreniere, Denise Lynn

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  7. 7
    FDA regulation on direct-to-consumer advertising vs. First Amendment right to free speech

    FDA regulation on direct-to-consumer advertising vs. First Amendment right to free speech by Hibbert, Matthew

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  8. 8
    The common technical document and the evolution of harmonizing global submissions : requirements and perspectives for implementation within the United States

    The common technical document and the evolution of harmonizing global submissions : requirements and perspectives for implementation within the United States by Walchle, Cynthia V.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  9. 9
    Regulatory acceptance of alternative methods to in vivo animal studies for toxicology/safety data

    Regulatory acceptance of alternative methods to in vivo animal studies for toxicology/safety data by McCormick, Kelsey

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  10. 10
    Protecting patient privacy : the Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") and implications on the conduct of pharmaceutical clinical trials : a case study

    Protecting patient privacy : the Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") and implications on the conduct of pharmaceutical clinical t... by Sojka, Debra Ann

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  11. 11
    The growing issue of financial conflict of interest in clinical research : "beyond pens and note pads"

    The growing issue of financial conflict of interest in clinical research : "beyond pens and note pads" by Lazaro, Emmanuel D.

    Published 2003
    “…M.S. Thesis 2003…”
    Thesis Book
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  12. 12
    Legislative and regulatory responses to inadequate pediatric labeling of human drugs

    Legislative and regulatory responses to inadequate pediatric labeling of human drugs by Scocca, Marion

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  13. 13
    Gamma-hydroxy butyrate and its precursor - 1,4-butanediol - as a dopamine modulator : an in vivo and in vitro evaluation

    Gamma-hydroxy butyrate and its precursor - 1,4-butanediol - as a dopamine modulator : an in vivo and in vitro evaluation by Shah, Pinank P.

    Published 2004.
    Thesis Book
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  14. 14
    Biological products guidance for post-approval changes contrasted against the Scale-Up and Post-Approval Changes (SUPAC) guidance

    Biological products guidance for post-approval changes contrasted against the Scale-Up and Post-Approval Changes (SUPAC) guidance by Curtis, Darren

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  15. 15
    Development and in-vitro evaluation of osmotic drug delivery system for propranolol hydrochloride using asymmetric membrane coatings

    Development and in-vitro evaluation of osmotic drug delivery system for propranolol hydrochloride using asymmetric membrane coatings by Garg, Amit

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  16. 16
    Challenges of post marketing approval in Brazil : (a primer of registrations and permits)

    Challenges of post marketing approval in Brazil : (a primer of registrations and permits) by Belt, Timothy W.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  17. 17
    Research and human subjects with decisional impairments : proposed guidance for the research community

    Research and human subjects with decisional impairments : proposed guidance for the research community by Barnard, Deborah L.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  18. 18
    Preparation and in-vitro evaluation of solid dispersions of famotidine with water soluble polymers like polyethylene glycol and polyvinylpyrrolidone

    Preparation and in-vitro evaluation of solid dispersions of famotidine with water soluble polymers like polyethylene glycol and polyvinylpyrrolidone by Taneja, Pankaj

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  19. 19
    Enzyme and receptor antagonists for acute and chronic toxicity from the gamma-hydroxybutyrate precursor 1,4-butanediol

    Enzyme and receptor antagonists for acute and chronic toxicity from the gamma-hydroxybutyrate precursor 1,4-butanediol by Desai, Malhar C.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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  20. 20
    The Humanitarian Device Exemption process : requirements and issues from application to utilization

    The Humanitarian Device Exemption process : requirements and issues from application to utilization by Connor, Janice H.

    Published 2003.
    “…M.S. Thesis 2003…”
    Thesis Book
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