Pharmacokinetics, distribution, and excretion of 125I-labeled human plasma-derived-FVIIa and -FX with MC710 (FVIIa/FX mixture) in rats
MC710 is a mixture agent consisting of plasma-derived activated factor VII (FVIIa) and factor X (FX) at a weight ratio of 1:10 developed as a novel bypassing agent for the management of the bleeding of hemophilia patients with inhibitors. The pharmacokinetics, distribution, and excretion of 125I-lab...
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| Veröffentlicht in: | Thrombosis research 2012, Vol.129 (1), p.62-67 |
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| creator | Nakatomi, Yasushi Tsuji, Manami Nakashima, Teruhisa Gokudan, Soutaro Miyazaki, Hiroki Tomokiyo, Kazuhiko Ogata, Yoichi Harano, Satomi Matsui, Hajime Shigaki, Takamichi Nakamura, Takahiro Mogi, Masayuki |
| description | MC710 is a mixture agent consisting of plasma-derived activated factor VII (FVIIa) and factor X (FX) at a weight ratio of 1:10 developed as a novel bypassing agent for the management of the bleeding of hemophilia patients with inhibitors. The pharmacokinetics, distribution, and excretion of
125I-labeled-FVIIa (
125I-FVIIa) and -FX (
125I-FX) were studied in male rats after a single intravenous administration of
125I-FVIIa or
125I-FX combined with MC710.
125I-FVIIa or
125I-FX was administered intravenously with MC710 to male rats in a single dosage (FVIIa 0.4
mg and FX 4
mg/kg body weight) and radioactivity and antigen levels in plasma were quantified for 24
h. Urine and feces were sampled to study the excretion of radioactivity during 168
h after dosing. Whole-body autoradiography was performed to evaluate the qualitative distribution of radioactivity 168
h after dosing.
The half-life (t
1/2α and t
1/2β) of radioactivity and FVIIa antigen were 0.704 and 6.27
h, and 0.496 and 1.66
h, respectively and the area under the plasma concentration–time curve (AUC
0–∞) of radioactivity and FVIIa antigen were 17,932 and 8671
ng·h/mL, respectively. The t
1/2 of radioactivity and FX antigen were 4.06 and 3.05
h, respectively, and the AUC
0–∞ of radioactivity and FX antigen were 320,143 and 395,794
ng·h/mL, respectively. About 80% of the administered dose of radioactivity was excreted in urine and feces by 168
h after administration. Tissue distribution experiments showed that FVIIa- and FX-related
125I accumulated in bone and bone marrow, and disappeared slowly. |
| doi_str_mv | 10.1016/j.thromres.2011.04.013 |
| format | Article |
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125I-labeled-FVIIa (
125I-FVIIa) and -FX (
125I-FX) were studied in male rats after a single intravenous administration of
125I-FVIIa or
125I-FX combined with MC710.
125I-FVIIa or
125I-FX was administered intravenously with MC710 to male rats in a single dosage (FVIIa 0.4
mg and FX 4
mg/kg body weight) and radioactivity and antigen levels in plasma were quantified for 24
h. Urine and feces were sampled to study the excretion of radioactivity during 168
h after dosing. Whole-body autoradiography was performed to evaluate the qualitative distribution of radioactivity 168
h after dosing.
The half-life (t
1/2α and t
1/2β) of radioactivity and FVIIa antigen were 0.704 and 6.27
h, and 0.496 and 1.66
h, respectively and the area under the plasma concentration–time curve (AUC
0–∞) of radioactivity and FVIIa antigen were 17,932 and 8671
ng·h/mL, respectively. The t
1/2 of radioactivity and FX antigen were 4.06 and 3.05
h, respectively, and the AUC
0–∞ of radioactivity and FX antigen were 320,143 and 395,794
ng·h/mL, respectively. About 80% of the administered dose of radioactivity was excreted in urine and feces by 168
h after administration. Tissue distribution experiments showed that FVIIa- and FX-related
125I accumulated in bone and bone marrow, and disappeared slowly.</description><identifier>ISSN: 0049-3848</identifier><identifier>EISSN: 1879-2472</identifier><identifier>DOI: 10.1016/j.thromres.2011.04.013</identifier><identifier>PMID: 21621824</identifier><identifier>CODEN: THBRAA</identifier><language>eng</language><publisher>Amsterdam: Elsevier Ltd</publisher><subject>Animals ; Area Under Curve ; Biological and medical sciences ; Blood and lymphatic vessels ; Bone and Bones - metabolism ; Bone Marrow - metabolism ; Bypassing agents ; Cardiology. Vascular system ; Coagulants - administration & dosage ; Coagulants - blood ; Coagulants - pharmacokinetics ; Coagulants - urine ; Coronary heart disease ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Drug Combinations ; Enzyme-Linked Immunosorbent Assay ; Factor VIIa - administration & dosage ; Factor VIIa - pharmacokinetics ; Factor VIIa - pharmacology ; Factor VIIa - urine ; Factor X - administration & dosage ; Factor X - pharmacokinetics ; Factor X - urine ; Feces - chemistry ; FVIIa ; Half-Life ; Heart ; Hemophilia ; Humans ; Inhibitor ; Injections, Intravenous ; Iodine Radioisotopes ; Male ; Medical sciences ; Rats ; Tissue Distribution</subject><ispartof>Thrombosis research, 2012, Vol.129 (1), p.62-67</ispartof><rights>2011 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c312t-de7f6de263404f05b7bbb5ceaf8372cb286a8e1d8393cbb6510308fe2117eeed3</citedby><cites>FETCH-LOGICAL-c312t-de7f6de263404f05b7bbb5ceaf8372cb286a8e1d8393cbb6510308fe2117eeed3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0049384811001769$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25386087$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21621824$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakatomi, Yasushi</creatorcontrib><creatorcontrib>Tsuji, Manami</creatorcontrib><creatorcontrib>Nakashima, Teruhisa</creatorcontrib><creatorcontrib>Gokudan, Soutaro</creatorcontrib><creatorcontrib>Miyazaki, Hiroki</creatorcontrib><creatorcontrib>Tomokiyo, Kazuhiko</creatorcontrib><creatorcontrib>Ogata, Yoichi</creatorcontrib><creatorcontrib>Harano, Satomi</creatorcontrib><creatorcontrib>Matsui, Hajime</creatorcontrib><creatorcontrib>Shigaki, Takamichi</creatorcontrib><creatorcontrib>Nakamura, Takahiro</creatorcontrib><creatorcontrib>Mogi, Masayuki</creatorcontrib><title>Pharmacokinetics, distribution, and excretion of 125I-labeled human plasma-derived-FVIIa and -FX with MC710 (FVIIa/FX mixture) in rats</title><title>Thrombosis research</title><addtitle>Thromb Res</addtitle><description>MC710 is a mixture agent consisting of plasma-derived activated factor VII (FVIIa) and factor X (FX) at a weight ratio of 1:10 developed as a novel bypassing agent for the management of the bleeding of hemophilia patients with inhibitors. The pharmacokinetics, distribution, and excretion of
125I-labeled-FVIIa (
125I-FVIIa) and -FX (
125I-FX) were studied in male rats after a single intravenous administration of
125I-FVIIa or
125I-FX combined with MC710.
125I-FVIIa or
125I-FX was administered intravenously with MC710 to male rats in a single dosage (FVIIa 0.4
mg and FX 4
mg/kg body weight) and radioactivity and antigen levels in plasma were quantified for 24
h. Urine and feces were sampled to study the excretion of radioactivity during 168
h after dosing. Whole-body autoradiography was performed to evaluate the qualitative distribution of radioactivity 168
h after dosing.
The half-life (t
1/2α and t
1/2β) of radioactivity and FVIIa antigen were 0.704 and 6.27
h, and 0.496 and 1.66
h, respectively and the area under the plasma concentration–time curve (AUC
0–∞) of radioactivity and FVIIa antigen were 17,932 and 8671
ng·h/mL, respectively. The t
1/2 of radioactivity and FX antigen were 4.06 and 3.05
h, respectively, and the AUC
0–∞ of radioactivity and FX antigen were 320,143 and 395,794
ng·h/mL, respectively. About 80% of the administered dose of radioactivity was excreted in urine and feces by 168
h after administration. Tissue distribution experiments showed that FVIIa- and FX-related
125I accumulated in bone and bone marrow, and disappeared slowly.</description><subject>Animals</subject><subject>Area Under Curve</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Bone and Bones - metabolism</subject><subject>Bone Marrow - metabolism</subject><subject>Bypassing agents</subject><subject>Cardiology. Vascular system</subject><subject>Coagulants - administration & dosage</subject><subject>Coagulants - blood</subject><subject>Coagulants - pharmacokinetics</subject><subject>Coagulants - urine</subject><subject>Coronary heart disease</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Drug Combinations</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Factor VIIa - administration & dosage</subject><subject>Factor VIIa - pharmacokinetics</subject><subject>Factor VIIa - pharmacology</subject><subject>Factor VIIa - urine</subject><subject>Factor X - administration & dosage</subject><subject>Factor X - pharmacokinetics</subject><subject>Factor X - urine</subject><subject>Feces - chemistry</subject><subject>FVIIa</subject><subject>Half-Life</subject><subject>Heart</subject><subject>Hemophilia</subject><subject>Humans</subject><subject>Inhibitor</subject><subject>Injections, Intravenous</subject><subject>Iodine Radioisotopes</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Rats</subject><subject>Tissue Distribution</subject><issn>0049-3848</issn><issn>1879-2472</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc9uEzEQxi0EoqHwCpUvCJC6qcfetb03UEQgUhEcAHGzvPas4rB_gu0t5QV4bjZNCkdOo5n5fTOj-Qi5ALYEBvJqt8zbOPYR05IzgCUrlwzEA7IAreqCl4o_JAvGyroQutRn5ElKO8ZAQV09JmccJAfNywX5_WlrY2_d-D0MmINLl9SHlGNophzG4ZLawVO8dREPKR1bCrzaFJ1tsENPt1NvB7rvbOpt4TGGG_TF-utmY--Exfob_Rnyln5YKWD05V3nai724TZPEV_RMNBoc3pKHrW2S_jsFM_Jl_Xbz6v3xfXHd5vVm-vCCeB53qBa6ZFLUbKyZVWjmqapHNpWC8Vdw7W0GsFrUQvXNLICJphukQMoRPTinLw4zt3H8ceEKZs-JIddZwccp2Rq4KqupGQzKY-ki2NKEVuzj6G38ZcBZg4WmJ25t8AcLDCsNLMFs_DitGJqevR_Zfc_n4HnJ8AmZ7s22sGF9I-rhJZMq5l7feRwfshNwGiSCzg49CGiy8aP4X-3_AFrgaeg</recordid><startdate>2012</startdate><enddate>2012</enddate><creator>Nakatomi, Yasushi</creator><creator>Tsuji, Manami</creator><creator>Nakashima, Teruhisa</creator><creator>Gokudan, Soutaro</creator><creator>Miyazaki, Hiroki</creator><creator>Tomokiyo, Kazuhiko</creator><creator>Ogata, Yoichi</creator><creator>Harano, Satomi</creator><creator>Matsui, Hajime</creator><creator>Shigaki, Takamichi</creator><creator>Nakamura, Takahiro</creator><creator>Mogi, Masayuki</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>2012</creationdate><title>Pharmacokinetics, distribution, and excretion of 125I-labeled human plasma-derived-FVIIa and -FX with MC710 (FVIIa/FX mixture) in rats</title><author>Nakatomi, Yasushi ; Tsuji, Manami ; Nakashima, Teruhisa ; Gokudan, Soutaro ; Miyazaki, Hiroki ; Tomokiyo, Kazuhiko ; Ogata, Yoichi ; Harano, Satomi ; Matsui, Hajime ; Shigaki, Takamichi ; Nakamura, Takahiro ; Mogi, Masayuki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c312t-de7f6de263404f05b7bbb5ceaf8372cb286a8e1d8393cbb6510308fe2117eeed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Animals</topic><topic>Area Under Curve</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Bone and Bones - metabolism</topic><topic>Bone Marrow - metabolism</topic><topic>Bypassing agents</topic><topic>Cardiology. Vascular system</topic><topic>Coagulants - administration & dosage</topic><topic>Coagulants - blood</topic><topic>Coagulants - pharmacokinetics</topic><topic>Coagulants - urine</topic><topic>Coronary heart disease</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</topic><topic>Drug Combinations</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Factor VIIa - administration & dosage</topic><topic>Factor VIIa - pharmacokinetics</topic><topic>Factor VIIa - pharmacology</topic><topic>Factor VIIa - urine</topic><topic>Factor X - administration & dosage</topic><topic>Factor X - pharmacokinetics</topic><topic>Factor X - urine</topic><topic>Feces - chemistry</topic><topic>FVIIa</topic><topic>Half-Life</topic><topic>Heart</topic><topic>Hemophilia</topic><topic>Humans</topic><topic>Inhibitor</topic><topic>Injections, Intravenous</topic><topic>Iodine Radioisotopes</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Rats</topic><topic>Tissue Distribution</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakatomi, Yasushi</creatorcontrib><creatorcontrib>Tsuji, Manami</creatorcontrib><creatorcontrib>Nakashima, Teruhisa</creatorcontrib><creatorcontrib>Gokudan, Soutaro</creatorcontrib><creatorcontrib>Miyazaki, Hiroki</creatorcontrib><creatorcontrib>Tomokiyo, Kazuhiko</creatorcontrib><creatorcontrib>Ogata, Yoichi</creatorcontrib><creatorcontrib>Harano, Satomi</creatorcontrib><creatorcontrib>Matsui, Hajime</creatorcontrib><creatorcontrib>Shigaki, Takamichi</creatorcontrib><creatorcontrib>Nakamura, Takahiro</creatorcontrib><creatorcontrib>Mogi, Masayuki</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Thrombosis research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nakatomi, Yasushi</au><au>Tsuji, Manami</au><au>Nakashima, Teruhisa</au><au>Gokudan, Soutaro</au><au>Miyazaki, Hiroki</au><au>Tomokiyo, Kazuhiko</au><au>Ogata, Yoichi</au><au>Harano, Satomi</au><au>Matsui, Hajime</au><au>Shigaki, Takamichi</au><au>Nakamura, Takahiro</au><au>Mogi, Masayuki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics, distribution, and excretion of 125I-labeled human plasma-derived-FVIIa and -FX with MC710 (FVIIa/FX mixture) in rats</atitle><jtitle>Thrombosis research</jtitle><addtitle>Thromb Res</addtitle><date>2012</date><risdate>2012</risdate><volume>129</volume><issue>1</issue><spage>62</spage><epage>67</epage><pages>62-67</pages><issn>0049-3848</issn><eissn>1879-2472</eissn><coden>THBRAA</coden><abstract>MC710 is a mixture agent consisting of plasma-derived activated factor VII (FVIIa) and factor X (FX) at a weight ratio of 1:10 developed as a novel bypassing agent for the management of the bleeding of hemophilia patients with inhibitors. The pharmacokinetics, distribution, and excretion of
125I-labeled-FVIIa (
125I-FVIIa) and -FX (
125I-FX) were studied in male rats after a single intravenous administration of
125I-FVIIa or
125I-FX combined with MC710.
125I-FVIIa or
125I-FX was administered intravenously with MC710 to male rats in a single dosage (FVIIa 0.4
mg and FX 4
mg/kg body weight) and radioactivity and antigen levels in plasma were quantified for 24
h. Urine and feces were sampled to study the excretion of radioactivity during 168
h after dosing. Whole-body autoradiography was performed to evaluate the qualitative distribution of radioactivity 168
h after dosing.
The half-life (t
1/2α and t
1/2β) of radioactivity and FVIIa antigen were 0.704 and 6.27
h, and 0.496 and 1.66
h, respectively and the area under the plasma concentration–time curve (AUC
0–∞) of radioactivity and FVIIa antigen were 17,932 and 8671
ng·h/mL, respectively. The t
1/2 of radioactivity and FX antigen were 4.06 and 3.05
h, respectively, and the AUC
0–∞ of radioactivity and FX antigen were 320,143 and 395,794
ng·h/mL, respectively. About 80% of the administered dose of radioactivity was excreted in urine and feces by 168
h after administration. Tissue distribution experiments showed that FVIIa- and FX-related
125I accumulated in bone and bone marrow, and disappeared slowly.</abstract><cop>Amsterdam</cop><pub>Elsevier Ltd</pub><pmid>21621824</pmid><doi>10.1016/j.thromres.2011.04.013</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0049-3848 |
| ispartof | Thrombosis research, 2012, Vol.129 (1), p.62-67 |
| issn | 0049-3848 1879-2472 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_912795660 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Animals Area Under Curve Biological and medical sciences Blood and lymphatic vessels Bone and Bones - metabolism Bone Marrow - metabolism Bypassing agents Cardiology. Vascular system Coagulants - administration & dosage Coagulants - blood Coagulants - pharmacokinetics Coagulants - urine Coronary heart disease Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Drug Combinations Enzyme-Linked Immunosorbent Assay Factor VIIa - administration & dosage Factor VIIa - pharmacokinetics Factor VIIa - pharmacology Factor VIIa - urine Factor X - administration & dosage Factor X - pharmacokinetics Factor X - urine Feces - chemistry FVIIa Half-Life Heart Hemophilia Humans Inhibitor Injections, Intravenous Iodine Radioisotopes Male Medical sciences Rats Tissue Distribution |
| title | Pharmacokinetics, distribution, and excretion of 125I-labeled human plasma-derived-FVIIa and -FX with MC710 (FVIIa/FX mixture) in rats |
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