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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
1995-6-5
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pubmed:abstractText |
The pharmacokinetics of intravenously administered recombinant human factor IX (rhFIX) were studied in Sprague-Dawley rats and Beagle dogs. Rats received rhFIX (50 IU/kg once daily) for 28 days, and the plasma half-life was 5 h. Anti-Human Factor IX serum antibody levels were found in only 1 of 12 rats. The pharmacokinetic profiles of rhFIX or Mononine, a purified human plasma-derived factor IX, after single 100 IU/kg i.v. doses in dogs, were similar. Peak plasma concentrations of rhFIX and Mononine were 4-5 micrograms/ml. The mean plasma half-lives were 13.2 +/- 1.6 h for rhFIX and 13.3 +/- 1.6 h for Mononine. Dogs also received rhFIX (40 IU/kg i.v., daily) for 28 days or Mononine (40 IU/kg i.v. daily) for 14 days. Anti-human Factor IX serum antibody levels were determined for each compound. Pharmacokinetic half-lives decreased in these treated dogs which developed antihuman Factor IX antibodies. The antibody responses in 28 day rhFIX (40 IU/kg) dogs were similar to 14 day Mononine (40 IU/kg) dogs.
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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 |
Jan
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pubmed:issn |
0340-6245
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
73
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
101-5
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:7740479-Animals,
pubmed-meshheading:7740479-Antibody Formation,
pubmed-meshheading:7740479-Dogs,
pubmed-meshheading:7740479-Drug Administration Schedule,
pubmed-meshheading:7740479-Drug Evaluation, Preclinical,
pubmed-meshheading:7740479-Enzyme-Linked Immunosorbent Assay,
pubmed-meshheading:7740479-Factor IX,
pubmed-meshheading:7740479-Half-Life,
pubmed-meshheading:7740479-Injections, Intravenous,
pubmed-meshheading:7740479-Male,
pubmed-meshheading:7740479-Pilot Projects,
pubmed-meshheading:7740479-Rats,
pubmed-meshheading:7740479-Rats, Sprague-Dawley,
pubmed-meshheading:7740479-Recombinant Fusion Proteins,
pubmed-meshheading:7740479-Recombinant Proteins,
pubmed-meshheading:7740479-Species Specificity,
pubmed-meshheading:7740479-Time Factors
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pubmed:year |
1995
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pubmed:articleTitle |
Evaluation of recombinant human factor IX: pharmacokinetic studies in the rat and the dog.
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pubmed:affiliation |
Department of Preclinical Research, Genetics Institute, Inc., Cambridge, MA 02140, USA.
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pubmed:publicationType |
Journal Article,
Comparative Study
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