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Wyświetlanie 1-19 z 19
Tytuł :
Creatinine‐Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs.
Autorzy :
Zhang, Yifei
Sherwin, Catherine M.
Gonzalez, Daniel
Zhang, Qunshu
Khurana, Mona
Fisher, Jeffrey
Burckart, Gilbert J.
Wang, Yaning
Yao, Lynne P.
Ganley, Charles J.
Wang, Jian
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Temat :
KIDNEY physiology
DRUG analysis
CHILD patients
DRUG development
FUNCTIONAL assessment
PHARMACOKINETICS
GENERALIZED estimating equations
Źródło :
Clinical Pharmacology & Therapeutics; Jan2021, Vol. 109 Issue 1, p263-269, 7p
Czasopismo naukowe
Tytuł :
Creatinine-Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs.
Autorzy :
Zhang Y; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Sherwin CM; Department of Pediatrics, Wright State University School of Medicine, Dayton Children's Hospital, Dayton, Ohio, USA.
Gonzalez D; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Zhang Q; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Khurana M; Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Fisher J; Division of Biochemical Toxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Wang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Yao LP; Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ganley CJ; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Wang J; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Jan; Vol. 109 (1), pp. 263-269. Date of Electronic Publication: 2020 Aug 29.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Brain Tau Imaging: Food and Drug Administration Approval of F-Flortaucipir Injection.
Autorzy :
Mattay VS; Division of Imaging and Radiation Medicine, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; and.
Fotenos AF; Division of Imaging and Radiation Medicine, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; and.
Ganley CJ; Office of Specialty Medicine, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Marzella L; Division of Imaging and Radiation Medicine, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; and .
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Źródło :
Journal of nuclear medicine : official publication, Society of Nuclear Medicine [J Nucl Med] 2020 Oct; Vol. 61 (10), pp. 1411-1412. Date of Electronic Publication: 2020 Aug 04.
Typ publikacji :
Editorial
Opinia redakcyjna
Tytuł :
Safety Threshold Considerations for Sunscreen Systemic Exposure: A Simulation Study.
Autorzy :
Wang J; Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ganley CJ; Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2019 Jan; Vol. 105 (1), pp. 161-167. Date of Electronic Publication: 2018 Aug 09.
Typ publikacji :
Journal Article
MeSH Terms :
Models, Biological*
Benzophenones/*metabolism
Camphor/*analogs & derivatives
Skin Absorption/*physiology
Sunscreening Agents/*metabolism
United States Food and Drug Administration/*legislation & jurisprudence
Administration, Topical ; Benzophenones/administration & dosage ; Benzophenones/adverse effects ; Camphor/administration & dosage ; Camphor/adverse effects ; Camphor/metabolism ; Female ; Humans ; Male ; Middle Aged ; Nonprescription Drugs/administration & dosage ; Nonprescription Drugs/adverse effects ; Nonprescription Drugs/metabolism ; Skin Absorption/drug effects ; Sunscreening Agents/administration & dosage ; Sunscreening Agents/adverse effects ; United States ; Young Adult
Czasopismo naukowe
    Wyświetlanie 1-19 z 19

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