Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting.

Autor: Momper JD; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA., Heinrichs MT; US Food and Drug Administration, Silver Spring, Maryland, USA., Krudys K; US Food and Drug Administration, Silver Spring, Maryland, USA., Griebel D; US Food and Drug Administration, Silver Spring, Maryland, USA., Kumar S; US Food and Drug Administration, Silver Spring, Maryland, USA., Kim I; US Food and Drug Administration, Silver Spring, Maryland, USA., Mehrotra N; US Food and Drug Administration, Silver Spring, Maryland, USA., Mulberg AE; US Food and Drug Administration, Silver Spring, Maryland, USA., Garimella N; US Food and Drug Administration, Silver Spring, Maryland, USA., Nelson R; US Food and Drug Administration, Silver Spring, Maryland, USA., Reaman G; US Food and Drug Administration, Silver Spring, Maryland, USA., Sinha V; US Food and Drug Administration, Silver Spring, Maryland, USA., Yao L; US Food and Drug Administration, Silver Spring, Maryland, USA., Zineh I; US Food and Drug Administration, Silver Spring, Maryland, USA., Burckart G; US Food and Drug Administration, Silver Spring, Maryland, USA., Sachs H; US Food and Drug Administration, Silver Spring, Maryland, USA., Mulugeta Y; US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Journal of clinical pharmacology [J Clin Pharmacol] 2020 Jun; Vol. 60 (6), pp. 775-784. Date of Electronic Publication: 2020 Jan 22.

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Effect of functionalization on the adsorption performance of carbon nanotube as a drug delivery system for imatinib: molecular simulation study.

Autor: Rezazade, Masume¹ (AUTHOR), Ketabi, Sepideh² (AUTHOR) sepidehketabi@yahoo.com, Qomi, Mahnaz^1,3 (AUTHOR)

Publikováno v: BMC Chemistry. 4/27/2024, Vol. 18 Issue 1, p1-19. 19p.

Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients.

Autor: Wang J; Office of Clinical Pharmacology †Division of Gastroenterology and Inborn Error Products 1, Office of Drug Evaluation III, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Mehrotra N, Kim I, Lee SC, Sohrabi F, He R, Mulberg A, Sinha V, Ahn HY, Bashaw D, Griebel D

Publikováno v: Journal of pediatric gastroenterology and nutrition [J Pediatr Gastroenterol Nutr] 2016 Oct; Vol. 63 (4), pp. 412-6.

Immune response to enzyme replacement therapies in lysosomal storage diseases and the role of immune tolerance induction.

Autor: Kishnani PS; Division of Medical Genetics, Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA. Electronic address: priya.kishnani@duke.edu., Dickson PI; Division of Medical Genetics, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA 90505-2006, USA. Electronic address: pdickson@labiomed.org., Muldowney L; Division of Gastroenterology and Inborn Errors of Metabolism Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD 20993-0002, USA. Electronic address: laurie.muldowney@fda.hhs.gov., Lee JJ; Division of Gastroenterology and Inborn Errors of Metabolism Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD 20993-0002, USA. Electronic address: jessica.j.lee@fda.hhs.gov., Rosenberg A; Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA, Silver Spring, MD 20993-0002, USA. Electronic address: amy.rosenberg@fda.hhs.gov., Abichandani R; Shire, Lexington, MA 02421, USA. Electronic address: rabichan@shire.com., Bluestone JA; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143-0540, USA. Electronic address: jeff.bluestone@ucsf.edu., Burton BK; Northwestern University Feinberg School of Medicine, Ann & Robert H. Lurie Children's Hospital, Chicago, IL 60611, USA. Electronic address: bburton@luriechildrens.org., Dewey M; Division of Gastroenterology and Inborn Errors of Metabolism Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD 20993-0002, USA. Electronic address: maureen.dewey@fda.hhs.gov., Freitas A; National Organization for Rare Disorders, Washington, DC 20036, USA. Electronic address: afreitas@rarediseases.org., Gavin D; National Organization for Rare Disorders, Washington, DC 20036, USA. Electronic address: dgavin@rarediseases.org., Griebel D; Division of Gastroenterology and Inborn Errors of Metabolism Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD 20993-0002, USA. Electronic address: donna.griebel@fda.hhs.gov., Hogan M; Saving Case & Friends, Inc., a Hunter Syndrome Research Foundation, Thompson's Station, TN 37179, USA. Electronic address: melissa@savingcase.com., Holland S; National MPS Society, Durham, NC 27709, USA. Electronic address: steve.holland@thomsonreuters.com., Tanpaiboon P; Children's National Medical Center, Washington, DC 20010, USA. Electronic address: ptanpaib@childrensnational.org., Turka LA; Center for Transplantation Sciences, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02129, USA. Electronic address: lturka@partners.org., Utz JJ; University of Minnesota, Masonic Children's Hospital, Minneapolis, MN 55455, USA. Electronic address: utz002@umn.edu., Wang YM; Division of Clinical Pharmacology III, Office of Clinical Pharmacology, Office of Translational Sciences (OTS), CDER, FDA, Silver Spring, MD 20993-0002, USA. Electronic address: yowming.wang@fda.hhs.gov., Whitley CB; University of Minnesota, Masonic Children's Hospital, Minneapolis, MN 55455, USA. Electronic address: whitley@umn.edu., Kazi ZB; Division of Medical Genetics, Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA. Electronic address: zoheb.kazi@dm.duke.edu., Pariser AR; OTS, CDER, FDA, Silver Spring, MD 20993-0002, USA. Electronic address: anne.pariser@fda.hhs.gov.

Publikováno v: Molecular genetics and metabolism [Mol Genet Metab] 2016 Feb; Vol. 117 (2), pp. 66-83. Date of Electronic Publication: 2015 Nov 10.