Výsledky vyhledávání - "Howard E. Greenberg"

Midazolam Limited Sampling Strategy With a Population Pharmacokinetic Approach to Simultaneously Estimate Cytochrome P450 (CYP) 3A Constitutive, Inhibition, and Induction/Activation Conditions in Healthy Adults

Autor: Jincheng Yang, S. Aubrey Stoch, Anne N. Nafziger, Howard E. Greenberg, Shirley M. Tsunoda, Joseph S. Bertino, Joseph D. Ma, Edmund V. Capparelli, Mina Nikanjam, Scott R. Penzak

Publikováno v: The Journal of Clinical Pharmacology. 59:1495-1504

We have previously described a midazolam limited sampling strategy employing a population pharmacokinetic (PK) approach to estimate constitutive cytochrome P450 (CYP) 3A activity. This study evaluated expansion of this approach to estimate CYP3A cons

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dddba3bbc46271c3004dd91f442eb89f
https://doi.org/10.1002/jcph.1440

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A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products

Autor: Nataliya Mogles, Martin Rejzek, Esther Daemen, Mathew Whalen, Hervé Le Louet, Simon Whiteley, Jytte Lyndvig, Alan M. Hochberg, Jonathan M. Fishbein, Christine Prendergast, Bernard Bégaud, Kathyryn Owen, Ioannis M. Dokas, Sofia Trantza, Brian Edwards, David J. Webb, Howard E. Greenberg

Publikováno v: British Journal of Clinical Pharmacology. 83:2339-2342

This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity, including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigil

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b06f43b4889e952f22eba9a8d3f0f0b4
https://doi.org/10.1111/bcp.13353

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Comprehensive review of visual defects reported with topiramate

Autor: Fred Selan, Lisa Ford, Jeffrey L. Goldberg, Howard E. Greenberg, Yingqi Shi

Publikováno v: Clinical Ophthalmology (Auckland, N.Z.)

Objective The objective of this study was to analyze clinical patterns of visual field defects (VFDs) reported with topiramate treatment and assess possible mechanism of action (MOA) for antiepileptic drug (AED) associated VFDs. Methods A comprehensi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::55fac0000d063bbaf98f2e0fd4063461
https://doi.org/10.2147/opth.s125768

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Is uveitis associated with topiramate use? A cumulative review

Autor: Lisa Ford, Jeffrey L. Goldberg, Amy G Lau, Bo Fan, Howard E. Greenberg

Publikováno v: Clinical Ophthalmology (Auckland, N.Z.)

Jeffrey L Goldberg,1 Amy G Lau,2 Bo Fan,2 Lisa Ford,3 Howard E Greenberg3 1Byers Eye Institute, Stanford University, Palo Alto, CA, 2Janssen Research & Development, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Titusville, NJ, USA Abstract:

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d0e6be9459534a74b7c8d179d77add7c
http://europepmc.org/articles/PMC4977106

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Safety in FIH Trials: A Summary of the Symposium 'Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost'

Autor: Mary L Westrick, Mattheus Thijs van Iersel, William B. Smith, Howard E. Greenberg

Publikováno v: Therapeutic innovationregulatory science. 51(3)

A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in Philadelphia to discuss and critically analyze the first-in-human (FIH) clinical trial conducted by a French CRO with BIA 10-2

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c2444a19ec333fa70a347398c84ac2c1
https://pubmed.ncbi.nlm.nih.gov/30231706

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Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies: A Moderated Forum Session

Autor: Mary L Westrick, Howard E. Greenberg, Gary L. Steinman, William B. Smith

Publikováno v: Therapeutic innovationregulatory science. 51(3)

This paper summarizes a discussion that took place at the 52nd Annual DIA Meeting in Philadelphia, PA, on June 30, 2016, titled “Hot-Button Protocol and Operational Issues between Sponsors and Sites in Clinical Pharmacology Studies.” The symposiu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2f524d291a1696fb00985df96852e3b7
https://pubmed.ncbi.nlm.nih.gov/30231705

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Midazolam Single Time Point Concentrations to Estimate Exposure and Cytochrome P450 (CYP) 3A Constitutive Activity Utilizing Limited Sampling Strategy With a Population Pharmacokinetic Approach

Autor: Maulik Patel, S. Aubrey Stoch, Anne N. Nafziger, Jincheng Yang, Joseph D. Ma, Howard E. Greenberg, Edmund V. Capparelli, Joseph S. Bertino, Mina Nikanjam, Shirley M. Tsunoda, Scott R. Penzak

Publikováno v: Journal of clinical pharmacology. 58(9)

Midazolam is the preferred probe to phenotype cytochrome P450 (CYP) 3A activity. This study evaluated a single-concentration, midazolam limited sampling strategy utilizing a population pharmacokinetic (PK) approach to estimate area under the curve, a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ed2f696b82d44fc765401bf253487be8
https://pubmed.ncbi.nlm.nih.gov/29663428

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Safety and Immunogenicity of a Novel Staphylococcus aureus Vaccine: Results from the First Study of the Vaccine Dose Range in Humans

Autor: Nicholas A. Kartsonis, Jon Hartzel, Mark J. DiNubile, Walter A. Orenstein, Matthew T. Onorato, Eun J. Kwak, Robert F. Betts, Joy Lipka, Howard E. Greenberg, Clayton Harro

Publikováno v: Clinical and Vaccine Immunology. 17:1868-1874

Merck V710 is a novel vaccine containing the conserved Staphylococcus aureus iron surface determinant B shown to be protective in animal models. A phase I, multicenter, double-blind study of the dose range was conducted to assess the immunogenicity a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3590ef35c55163eddbe4d907feac83b5
https://doi.org/10.1128/cvi.00356-10

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Double-blind crossover study to assess potential differences in cytochrome P450 3A4 activity in healthy subjects receiving ondansetron plus dexamethasone, with and without aprepitant

Autor: M. Gail Murphy, Howard E. Greenberg, Anup K. Majumdar, Walter K. Kraft, Matthew P. Braun, Dennis C. Dean, Keith Gottesdiener, Kevin J. Petty, S. Aubrey Stoch, Margaret Fedgchin, Jack Valentine, Deborah Panebianco, Cynthia Gargano, Edward Pequignot

Publikováno v: Cancer Chemotherapy and Pharmacology. 67:1313-1321

Because glucocorticoids and the neurokinin-1 receptor antagonist aprepitant influence CYP3A4 activity, this study assessed whether aprepitant added to a 5-HT3 antagonist and glucocorticoid would affect CYP3A4 induction. In this double-blind, 2-period

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3be1f6da7adb2feae4e9c6db5bbb8fa5
https://doi.org/10.1007/s00280-010-1421-y

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Pharmacokinetics of Raltegravir in Individuals With UGT1A1 Polymorphisms

Autor: John A. Wagner, Julie A. Stone, James Kost, Larissa Wenning, Steven D. Young, Sheila Breidinger, EJ Carlini, NM Lunde, T Rushmore, Frank Wagner, Amelia S. Petry, Howard E. Greenberg, Bo Jin, I DeLepeleire, Marian Iwamoto, F Bieberdorf

Publikováno v: Clinical Pharmacology & Therapeutics. 85:623-627

Raltegravir is a human immunodeficiency virus-1 (HIV-1) integrase strand transfer inhibitor metabolized by glucuronidation via UDP-glucuronosyltransferase 1A1 (UGT1A1). In this study, 30 subjects with a UGT1A1*28/*28 genotype (associated with decreas

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8aeabe7773c2cf5fa52d255d8075a449
https://doi.org/10.1038/clpt.2009.12

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