Zobrazeno 1 - 10
of 137
pro vyhledávání: '"Wharton GT"'
Autor:
Wharton GT; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA., Becker C; Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy & Epidemiology, Department of Pharmaceutical Sciences, University Basel, Basel, Switzerland., Bennett D; Global Evidence and Outcomes, Safety Pharmacoepidemiology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Burcu M; Department of Epidemiology, Merck & Co., Inc., Rahway, New Jersey, USA., Bushnell G; Department of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA., Ferrajolo C; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.; Department of Experimental Medicine, Section of Pharmacology, 'L. Donatelli', University of Campania 'Luigi Vanvitelli', Naples, Italy., Kaplan S; Department Pharmacoepidemiology, Teva Pharmaceutical Industries Ltd, Netanya, Israel., McMahon AW; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA., Movva N; EpidStrategies, A Division of ToxStrategies Inc, Rockville, Maryland, USA., Raman SR; Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA., Scholle O; Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany., Suh M; EpidStrategies, A Division of ToxStrategies Inc, Rockville, Maryland, USA., Sun JW; Safety Surveillance Research, Pfizer Inc., New York, New York, USA., Horton DB; Department of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.; Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
Publikováno v:
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2024 Jan; Vol. 33 (1), pp. e5695. Date of Electronic Publication: 2023 Sep 10.
Autor:
Park K; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Virparia R; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA., Green DJ; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., Epps C; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., Wharton GT; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., McCune SK; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Publikováno v:
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Oct; Vol. 110 (4), pp. 997-1003. Date of Electronic Publication: 2021 Jun 14.
Autor:
Downes KJ; Division of Infectious Disease, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Research Institute, Philadelphia, PA; Department of Pediatrics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA. Electronic address: downeskj@email.chop.edu., Boge CLK; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Research Institute, Philadelphia, PA., Baro E; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Wharton GT; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD., Liston KM; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Research Institute, Philadelphia, PA., Haltzman BL; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Research Institute, Philadelphia, PA., Emerson HM; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Research Institute, Philadelphia, PA., Doe E; Neonatal Intensive Care, Inova Children's Hospital, Falls Church, VA., Fulchiero R; Neonatal Intensive Care, Inova Children's Hospital, Falls Church, VA., Tran V; Neonatal Intensive Care, Inova Children's Hospital, Falls Church, VA., Yen L; Department of Pharmacy, Children's Hospital Los Angeles, Los Angeles, CA., Lieu P; Department of Pharmacy, Children's Hospital Los Angeles, Los Angeles, CA., Van Driest SL; Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN., Grisso AG; Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN., Aka IT; Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN., Hale J; Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN., Gillon J; Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN., Pingel JS; Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN., Coffin SE; Division of Infectious Disease, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Research Institute, Philadelphia, PA; Department of Pediatrics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA., McMahon AW; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD.
Publikováno v:
The Journal of pediatrics [J Pediatr] 2020 Apr; Vol. 219, pp. 126-132.e2. Date of Electronic Publication: 2020 Feb 06.
Autor:
Oshikoya KA; Vanderbilt University School of Medicine, Nashville, TN, USA., Wharton GT; Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Building 32, Room 5158, Silver Spring, MD, 20993, USA., Avant D; Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Building 32, Room 5158, Silver Spring, MD, 20993, USA., Van Driest SL; Vanderbilt University School of Medicine, Nashville, TN, USA., Fenn NE 3rd; Children's National Health System, Washington, DC, USA., Lardieri A; University of Maryland Children's Hospital, Baltimore, MD, USA., Doe E; INOVA Children's Hospital, Falls Church, VA, USA., Sood BG; Children's Hospital of Michigan, Detroit, MI, USA., Taketomo C; Children's Hospital Los Angeles, Los Angeles, CA, USA., Lieu P; Children's Hospital Los Angeles, Los Angeles, CA, USA., Yen L; Children's Hospital Los Angeles, Los Angeles, CA, USA., McMahon AW; Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Building 32, Room 5158, Silver Spring, MD, 20993, USA. Ann.mcmahon@fda.hhs.gov.
Publikováno v:
Paediatric drugs [Paediatr Drugs] 2019 Feb; Vol. 21 (1), pp. 47-58.
Autor:
Avant D; Offices of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD. Electronic address: Debbie.Avant@fda.hhs.gov., Wharton GT; Offices of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD., Murphy D; Offices of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
Publikováno v:
The Journal of pediatrics [J Pediatr] 2018 Jan; Vol. 192, pp. 8-12. Date of Electronic Publication: 2017 Oct 10.
Autor:
McMahon AW; Office of Pediatric Therapeutics, Food and Drug Administration, Silver Spring, MD, USA., Wharton GT; Office of Pediatric Therapeutics, Food and Drug Administration, Silver Spring, MD, USA., Thornton P; Cook Children's Medical Center, Fort Worth, TX, USA., De Leon DD; Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Publikováno v:
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2017 Jan; Vol. 26 (1), pp. 26-31. Date of Electronic Publication: 2016 Dec 02.
A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.
Autor:
Egger GF; European Medicines Agency, London, United Kingdom., Wharton GT; US Food and Drug Administration, Silver Spring, MD, USA., Malli S; US Food and Drug Administration, Silver Spring, MD, USA., Temeck J; US Food and Drug Administration, Silver Spring, MD, USA., Murphy MD; US Food and Drug Administration, Silver Spring, MD, USA., Tomasi P; European Medicines Agency, London, United Kingdom.
Publikováno v:
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2016 Sep; Vol. 50 (5), pp. 639-647. Date of Electronic Publication: 2016 May 13.
Autor:
McMahon AW; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., Wharton GT; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., Bonnel R; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., DeCelle M; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., Swank K; Office of Pharmacovigilance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA., Testoni D; Duke Clinical Research Institute, Duke School of Medicine, Durham, NC, USA., Cope JU; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., Smith PB; Duke Clinical Research Institute, Duke School of Medicine, Durham, NC, USA., Wu E; Office of Pharmacovigilance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA., Murphy MD; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
Publikováno v:
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2015 Aug; Vol. 24 (8), pp. 785-92. Date of Electronic Publication: 2015 Jun 22.
Autor:
Hilgers, Rob H.P., Das, Kumuda C.
Publikováno v:
Antioxidants & Redox Signaling; Nov2024, Vol. 41 Issue 13/15, p818-844, 27p
Autor:
Wharton GT; Offices of Pediatric Therapeutics, and gerold.wharton@fda.hhs.gov., Murphy MD; Offices of Pediatric Therapeutics, and., Avant D; Offices of Pediatric Therapeutics, and., Goldsmith JV; Policy and Planning, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland;, Chai G; Office of Surveillance and Epidemiology, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland;United States Public Health Service; and., Rodriguez WJ; Offices of Pediatric Therapeutics, and., Eisenstein EL; Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Publikováno v:
Pediatrics [Pediatrics] 2014 Aug; Vol. 134 (2), pp. e512-8. Date of Electronic Publication: 2014 Jul 14.