Search Results - BIRNKRANT, Debra B

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  1. 1
    Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States

    Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States by Wu, Kuei-Meng, Ghantous, Hanan, Birnkrant, Debra B.

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  2. 2
    Clinical experience with intravenous zanamivir under an Emergency IND program in the United States (2011-2014)

    Clinical experience with intravenous zanamivir under an Emergency IND program in the United States (2011-2014) by Chan-Tack, Kirk M, Kim, Christine, Moruf, Alicia, Birnkrant, Debra B

    Published in Antiviral therapy
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  3. 3
    Clinical Experience With Intravenous Zanamivir Under an Emergency Investigational New Drug Program in the United States

    Clinical Experience With Intravenous Zanamivir Under an Emergency Investigational New Drug Program in the United States by Chan-Tack, Kirk M., Gao, Arlene, Himaya, Amalia C., Thompson, Elizabeth G., Singer, Mary E., Uyeki, Timothy M., Birnkrant, Debra B.

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  4. 4
    Running a tightrope: Regulatory challenges in the development of antiretrovirals

    Running a tightrope: Regulatory challenges in the development of antiretrovirals by Naeger, Lisa K., Struble, Kimberly A., Murray, Jeffrey S., Birnkrant, Debra B.

    Published in Antiviral research
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  5. 5
    Reporting of deaths during pre-approval clinical trials for advanced HIV-infected populations

    Reporting of deaths during pre-approval clinical trials for advanced HIV-infected populations by JOHANN-LIANG, Rosemary, JAMES, Andrea N, BEHR, Virginia L, STRUBLE, Kimberly, BIRNKRANT, Debra B

    Published in Drug safety
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  6. 6
    Botanical Drug Development: Waiver of Preclinical Pharm/Tox Studies and Importance of Initial Cinical Trial Design

    Botanical Drug Development: Waiver of Preclinical Pharm/Tox Studies and Importance of Initial Cinical Trial Design by Wu, Kuei‐Meng, Ghantous, Hanan, Birnkrant, Debra B.

    Published in The FASEB journal
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  7. 7
    Botanical Drug Product Development in the U.S.A.: Importance of Genotoxicity Testing

    Botanical Drug Product Development in the U.S.A.: Importance of Genotoxicity Testing by Wu, Kuei‐Meng, Ghantous, Hanan, Birnkrant, Debra B.

    Published in The FASEB journal
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  8. 8
    Running a tightrope: Regulatory challenges in the development of antiretrovirals: Twenty-five Years of Antiretroviral Drug Development: Progress and Prospects

    Running a tightrope: Regulatory challenges in the development of antiretrovirals: Twenty-five Years of Antiretroviral Drug Development: Progress and Prospects by NAEGER, Lisa K, STRUBLE, Kimberly A, MURRAY, Jeffrey S, BIRNKRANT, Debra B

    Published in Antiviral research
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  9. 9
    Evaluation of SARS-CoV-2 RNA Rebound After Nirmatrelvir/Ritonavir Treatment in Randomized, Double-Blind, Placebo-Controlled Trials - United States and International Sites, 2021-2022

    Evaluation of SARS-CoV-2 RNA Rebound After Nirmatrelvir/Ritonavir Treatment in Randomized, Double-Blind, Placebo-Controlled Trials - United States and International Sites, 2021-202... by Harrington, Patrick R, Cong, Jie, Troy, Stephanie B, Rawson, Jonathan M O, O'Rear, Julian J, Valappil, Thamban Illath, McGarry Connelly, Sarah, Farley, John, Birnkrant, Debra

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