Výsledky vyhledávání - "Richard Isbrucker"

Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals

Autor: Elliot Lilley, Ian Ragan, Richard Isbrucker, Anthony Holmes

Publikováno v: Biologicals : journal of the International Association of Biological Standardization. 74

Animal testing has long been integral to the development of biologicals, including vaccines. The use of animals can provide important information on potential toxicity, insights into their mechanism of action, pharmacokinetics and dynamics, physiolog

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4bcdc95c053daeecf87a91f3c43d81e
https://pubmed.ncbi.nlm.nih.gov/34750045

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Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path forward

Autor: Vivian W. Doelling, Warren Casey, Sue Nelson, Dorothy Xing, Brett Jones, Jean-Michel Chapsal, William S. Stokes, Christina Bache, Marlies Halder, Catherine S. Sprankle, Lori Rinckel, Richard McFarland, Amélie Castiaux, Angele Costanzo, Richard Isbrucker, Nelson W Johnson, Juan Arciniega, Marieke Hoonakker

Publikováno v: Biologicals. 42:114-122

Regulatory authorities require safety and potency testing prior to the release of each production lot of acellular pertussis (aP)-containing vaccines. Currently, the murine histamine sensitization test (HIST) is used to evaluate the presence of resid

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https://doi.org/10.1016/j.biologicals.2013.11.011

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Non-animal replacement methods for human vaccine potency testing: state of the science and future directions

Autor: David Allen, Dorothea Sesardic, Michael P. Schmitt, Yoshinobu Horiuchi, Paul Stickings, Johan Descamps, Warren Casey, Daniela Verthelyi, Richard Isbrucker, Elizabeth A. Lipscomb, Nelson W Johnson, Juan Arciniega, Richard McFarland, Theresa M. Finn

Publikováno v: Procedia in Vaccinology

NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods, and to identify opportunities to advance new and improved methods that can further reduce, re

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fcb6121b8a062f07d6c55e0e63e311c7
https://doi.org/10.1016/j.provac.2011.10.002

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Study of aggregation, denaturation and reduction of interferon alpha-2 products by size-exclusion high-performance liquid chromatography with fluorescence detection and biological assays

Autor: Abebaw Diress, Xuguang Li, Louise Larocque, Richard Isbrucker, Barry Lorbetskie, Michel Girard, Matthew Alteen

Publikováno v: Journal of Chromatography A. 1217:3297-3306

Interferon alpha-2 (IFN alpha-2) products have been widely used as antivirals for the treatment of serious diseases such as hepatitis B and C. However, reports of adverse reactions following treatment have prompted investigations into the cause of th

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https://doi.org/10.1016/j.chroma.2009.10.081

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Modified binding assay for improved sensitivity and specificity in the detection of residual pertussis toxin in vaccine preparations

Autor: Richard Isbrucker, Alex Bliu, Fiona A. Prior

Publikováno v: Vaccine. 28:2687-2692

A binding assay was recently published that differentiates between pertussis toxin (PTx) and the pertussis toxoid (PTd) used in acellular pertussis vaccines based on the selective binding of PTx to fetuin and detection with a polyclonal antibody. We

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https://doi.org/10.1016/j.vaccine.2010.01.040

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Results of an international transferability study of the BINACLE (binding and cleavage) assay for in vitro detection of tetanus toxicity

Autor: Ursula Bonifas, Heike A. Behrensdorf-Nicol, Hans-Peter Ottiger, Beate Krämer, Kay-Martin Hanschmann, Rob Tierney, Karin Weisser, Richard Isbrucker

Publikováno v: Biologicals : journal of the International Association of Biological Standardization. 42(4)

Tetanus vaccines contain detoxified tetanus neurotoxin. In order to check for residual toxicity, the detoxified material (toxoid) has to be tested in guinea pigs. These tests are time-consuming and raise animal welfare issues. In line with the "3R" p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::08b890f2440e2f03408b30d47ac0b236
https://pubmed.ncbi.nlm.nih.gov/24882365

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Acetylator phenotyping

Autor: Richard Isbrucker, Ban C. H. Tsui, Alastair E. Cribb, Terry L. LeVatte, C. T. Gillespie, Kenneth W. Renton

Publikováno v: Scopus-Elsevier

Eighteen healthy Caucasians were evaluated for the systemic acetylation of a caffeine metabolite using the urinary caffeine metabolite ratio 5-acetylamino-6-formylamino-3-methyluracil (AFMU) to 1-methylaxanthine (1X) and for N-acetyltransferase activ

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https://doi.org/10.1097/00008571-199406000-00009

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Health Canada's human vaccine lot release program: impact on the 3Rs

Autor: Dean Smith, Sushama Sontakke, Richard Isbrucker

Publikováno v: Procedia in Vaccinology. :147-150

Health Canada (HC) is Canada's national regulatory body that oversees the review, authorization, and lot (batch) release of human vaccines. All biologic drugs, including vaccines, are subject to the Biologics and Genetic Therapies Directorate's Lot R

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