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Anatomy / Hematology / Respiratory physiology / Emergency medicine / Equilibrium chemistry / Blood substitute / Haemoglobin-based oxygen carriers / Blood / Alpha-thalassemia / Medicine / Biology / Hemoglobins


Guidance for In Criteria for Safety and E Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes DRAFT GUIDANCE This guidance is being distributed for comment purposes only.
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Document Date: 2004-10-26 11:40:53


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File Size: 1,82 MB

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City

Rockville / /

Facility

Blood Institute / Suite 2OON / 1401 Rockville Pike / /

IndustryTerm

hemoglobin-basedoxygen carrier / clinical applications / bacterial product / cellular systems / oxygen therapeutic products / fkral product / modified hemoglobin products / Internet addressesfor / acellular hemoglobin product / hemoglobin products / oxygen carrier / chemical / in vivo reports suggestthat hemoglobin solutions / electrolyte solutions / /

MedicalCondition

infectious processesor / tumor necrosisfactor / cancer / tumors / demonstratedpulmonary arteritis / dysphagia / vascular inflammatory responseprogressingto multi-organ failure / focal and multifocal degenerationand/or necrosis / nausea / target tumor / pain / vomiting / enhancementof tumor / acute ischemic stroke / sepsis / free-radical mediated injury / /

MedicalTreatment

PTCA / catheter / angioplasty / Elective Surgery / radiation / /

Organization

Food and Drug Administration / Toxicity Administration / U.S. Department of Health and Human Services Food and Drug Administration Center / Armed ServicesBlood Program Office / Division of Dockets Management / FDA’s Center for Biolagics Evaluation and Research / U.S. Army Medical and Material Command / International Committee on Harmonization / Department of Defense / Symptoms Administration / Cardiac Toxicity Administration / National Heart / Lung / and Blood Institute / office of Communication / Training and Manufacturers Assistance / /

Person

Toby Silverman / /

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Position

investigator / A. General / Governor / BACKGROUND DISCUSSION A. General / /

ProvinceOrState

Maryland / /

Technology

radiation / Drug Development / /

URL

http /

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