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Erschienen in:

2013 | OriginalPaper | Buchkapitel

9. Regulatory Framework for Hemoglobin-Based Oxygen Carrier Trials

verfasst von : Basil Golding

Erschienen in: Hemoglobin-Based Oxygen Carriers as Red Cell Substitutes and Oxygen Therapeutics

Verlag: Springer Berlin Heidelberg

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Abstract

Oxygen therapeutics (OT) consist of hemoglobin-based oxygen carriers (HBOCs) and fluorocarbons. They have been developed to deliver oxygen (O₂₎ to tissues, mainly for treatment of shock due to blood loss. These products are being developed in order to treat blood loss when red blood cells are not available, as may occur on the battlefield or in civilian life when trauma occurs.

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Vorheriges Kapitel NIH/FDA/DOD Interagency Working Group on Oxygen Therapeutics

Nächstes Kapitel HBOCs from Chemical Modification of Hb

Buehler PW, Alayash AI (2008) All hemoglobin-based oxygen carriers are not created equally. Biochim Biophys Acta 1784(10):1378–81, Oct 2008, Epub 3 Jan. 2008

Buehler PW, D’Agnillo F, Schaer DJ (2010) Hemoglobin-based oxygen carriers: from mechanisms of toxicity and clearance to rational drug design. Trends Mol Med. 16(10):447–57, 2010, Epub 13 Aug 2010

Chen JY, Scerbo M, Kramer G (2009) A review of blood substitutes: examining the history, clinical trial results, and ethics of hemoglobin-based oxygen carriers. CLINICS 64(8):803–813CrossRef

Guidance for Industry (2004) Criteria for safety and efficacy evaluation of oxygen therapeutics as red blood cell substitutes, Draft Guidance, Oct 2004

Guidance for Industry (2008) CGMP for Phase 1 investigational drugs, July 2008

Guidance for Industry (2010) Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products

Guidance for Institutional Review Boards (2011) Clinical Investigators, and Sponsors Exception from Informed Consent Requirements for Emergency Research. U.S. Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health March 2011

Guideline for Good Clinical Practice (2002) ICH E6, July 2002

ICH Harmonised Tripartite Guideline Preclinical Safety Evaluation Of Biotechnology-Derived Pharmaceuticals S6(R1) 2008, Parent Guideline dated 16 July 1997, Current Step 4 version Addendum dated 12 June 2011 incorporated at the end of June 2011

ICH Topic E 8 (1998) General Considerations for Clinical Trials, March, 1998

ICH Topic Q 5 A (R1) (2000) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

Jahr JS, Akha AS, Holtby RJ (2012) Crosslinked, polymerized, and PEG-conjugated hemoglobin-based oxygen carriers: Clinical safety and efficacy of recent and current products. Current drug discovery technologies, Bentham Science Publishers, 9, p 158–165, 1875– 6220/12

Kazmierczak SC, Catrou PG, Boudreau D (1998) Simplified interpretative format for assessing test interference: studies with hemoglobin-based oxygen carrier solutions. Clin Chem 44:2347–2352

Meredith JW, Kilgo PD, Osler T (2003) A fresh set of survival risk ratios derived from incidents in the National Trauma Data Bank from which the ICISS may be calculated. J Trauma 55(5):924–932CrossRef

Monnet X, Teboul JL (2010) Early fluid resuscitation, Current Infect Dis Rep 12(5):354–360,

WHO (2006) Guidelines on tissue infectivity distribution in transmissible spongiform encephalopathies http://www.who.int/bloodproducts/tse/WHO%20TSE%20Guidelines%20FINAL-22%20JuneupdatedNL.pdf

Yücel N, Lefering R, Maegele M, Vorweg M, Tjardes T, Ruchholtz S, Neugebauer EA, Wappler F, Bouillon B, Rixen D (2006) Polytrauma study group of the german trauma society trauma associated severe hemorrhage (TASH)-score: probability of mass ransfusion as surrogate for life threatening hemorrhage after multiple trauma, J Trauma 60(6):1228–1236, 2006 (discussion 1236–1237)

Titel: Regulatory Framework for Hemoglobin-Based Oxygen Carrier Trials
verfasst von: Basil Golding
Verlag: Springer Berlin Heidelberg
Buch: Hemoglobin-Based Oxygen Carriers as Red Cell Substitutes and Oxygen Therapeutics
Print ISBN: 978-3-642-40716-1

Electronic ISBN: 978-3-642-40717-8

Copyright-Jahr: 2013
DOI: https://doi.org/10.1007/978-3-642-40717-8_9

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