Source:http://linkedlifedata.com/resource/pubmed/id/12162883
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
6
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pubmed:dateCreated |
2002-8-6
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pubmed:abstractText |
Safety and bioavailability of pulmonary delivered interferon-beta 1a (IFN-beta1a, AVONEX, Biogen, Inc., Cambridge, MA) was evaluated in the nonhuman primate. Pulmonary bioavailability following intratracheal (i.t.) instillation of 50 microg/kg IFN-beta1a to rhesus macaques was approximately 10%. To evaluate pulmonary safety, IFN-beta1a was administered intrabronchially to rhesus and cynomolgus macaques at a dose of 60 microg/dose one, three, or seven times per week for 4 weeks. At scheduled termination, lungs were evaluated for gross and histomorphologic changes. IFN-beta1a or vehicle (human serum albumin [HSA] in phosphate-buffered saline [PBS]) treatment resulted in minimal to mild subchronic alveolitis, located primarily near the instillation sites. These responses were considered nonspecific and consistent with either instillation of a foreign protein or minor injury associated with the instillation procedure. In one rhesus macaque treated every day for 4 weeks, IFN-beta1a induced mild to moderate eosinophilic alveolitis, considered possibly an isolated type I hypersensitivity response to HSA or IFN-beta1a. Partial resolution of pulmonary lesions was seen in all recovery animals killed 2 weeks after cessation of treatment. In conclusion, this study shows that pulmonary administration of human IFN-beta1a is safe and that the pulmonary route of administration is a possible alternate route for the systemic delivery of IFN-beta1a.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Jun
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pubmed:issn |
1079-9907
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
22
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
709-17
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:12162883-Absorption,
pubmed-meshheading:12162883-Animals,
pubmed-meshheading:12162883-Antibodies,
pubmed-meshheading:12162883-Biological Availability,
pubmed-meshheading:12162883-Dose-Response Relationship, Drug,
pubmed-meshheading:12162883-Drug Evaluation, Preclinical,
pubmed-meshheading:12162883-Female,
pubmed-meshheading:12162883-Humans,
pubmed-meshheading:12162883-Injections, Subcutaneous,
pubmed-meshheading:12162883-Instillation, Drug,
pubmed-meshheading:12162883-Interferon-beta,
pubmed-meshheading:12162883-Lung,
pubmed-meshheading:12162883-Macaca fascicularis,
pubmed-meshheading:12162883-Macaca mulatta,
pubmed-meshheading:12162883-Male,
pubmed-meshheading:12162883-Neopterin,
pubmed-meshheading:12162883-Recombinant Proteins
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pubmed:year |
2002
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pubmed:articleTitle |
Safety and systemic absorption of pulmonary delivered human IFN-beta1a in the nonhuman primate: comparison with subcutaneous dosing.
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pubmed:affiliation |
Biogen, Inc., Cambridge, MA 02142, USA. pauline_martin@biogen.com
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pubmed:publicationType |
Journal Article,
Comparative Study,
Research Support, Non-U.S. Gov't,
Evaluation Studies
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