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  • Circadian Rest-Activity Rhythms in Children with Leukemia on Dexamethasone
    UMB Dataset

    Authors
    Valerie E. Rogers
    Belinda Mandrell
    Description

    This study measured circadian activity rhythms (CAR) and fatigue in children and adolescents with acute lymphoblastic leukemia on maintenance chemotherapy during the 5 days prior to a pulse of dexamethasone and the 5 days after the start of dexamethasone. CAR was measured via an actigraph worn continuously for 10 days. Fatigue was measured at 4 time points. The fatigue measures used for this study were Fatigue Scale-Child, Fatigue Scale-Adolescent and Fatigue Scale-Parent. The aims of this descriptive study were to compare CAR during the periods before and during dexamethasone therapy, and to explore the hypothesis that less robust CAR was associated with greater fatigue.

    Subject
    Circadian Rhythm
    Dexamethasone
    Leukemia
    Geographic Coverage
    International
    United States
    Access Rights
    Unrestricted access

  • Substances nominated for inclusion on the 503B Bulks List: Dexamethasone Acetate
    UMB Dataset

    Alternate Title(s)
    Dexamethasone Acetate: Summary Report
    Authors
    SeJeong Yoon
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, dexamethasone acetate, were summarized in the Dexamethasone Acetate: Summary Report accessible via the UMB Digital Archive.

    Subject
    Dexamethasone Acetate
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access