Multispecies animal investigation on biodistribution, pharmacokinetics and toxicity of 177Lu-EDTMP, a potential bone pain palliation agent
Radionuclide therapy (RNT) is an effective method for bone pain palliation in patients suffering from bone metastasis. Due to the long half-life, easy production and relatively low β− energy, 177Lu [ T 1/2=6.73 days, E βmax=497 keV, E γ=113 keV (6.4%), 208 keV (11%)]-based radiopharmaceuticals offer...
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| creator | Máthé, Domokos Balogh, Lajos Polyák, András Király, Réka Márián, Teréz Pawlak, Dariusz Zaknun, John J. Pillai, Maroor R.A. Jánoki, Győző A. |
| description | Radionuclide therapy (RNT) is an effective method for bone pain palliation in patients suffering from bone metastasis. Due to the long half-life, easy production and relatively low β− energy,
177Lu [
T
1/2=6.73 days,
E
βmax=497 keV,
E
γ=113 keV (6.4%), 208 keV (11%)]-based radiopharmaceuticals offer logistical advantage for wider use. This paper reports the results of a multispecies biodistribution and toxicity studies of
177Lu-EDTMP to collect preclinical data for starting human clinical trials.
177Lu-EDTMP with radiochemical purity greater than 99% was formulated by using a lyophilized kit of EDTMP (35 mg of EDTMP, 5.72 g of CaO and 14.1 mg of NaOH). Biodistribution studies were conducted in mice and rabbits. Small animal imaging was performed using NanoSPECT/CT (Mediso, Ltd., Hungary) and digital autoradiography. Gamma camera imaging was done in rabbits and dogs. Four levels of activity (9.25 through 37 MBq/kg body weight) of
177Lu-EDTMP were injected in four groups of three dogs each to study the toxicological effects.
177Lu-EDTMP accumulated almost exclusively in the skeletal system (peak ca. 41% of the injected activity in bone with terminal elimination half-life of 2130 and 1870 h in mice and rabbits, respectively) with a peak uptake during 1–3 h. Excretion of the radiopharmaceutical was through the urinary system. Imaging studies showed that all species (mouse, rat, rabbit and dog) take up the compound in regions of remodeling bone, while kidney retention is not visible after 1 day postinjection (pi). In dogs, the highest applied activity (37 MBq/kg body weight) led to a moderate decrease in platelet concentration (mean, 160 g/L) at 1 week pi with no toxicity.
The protracted effective half-life of
177Lu-EDTMP in bone supports that modifying the EDTMP molecule by introducing
177Lu does not alter its biological behaviour as a specific bone-seeking tracer. Species-specific pharmacokinetic behavior differences were observed. Toxicity studies in dogs did not show any biological adverse effects. The studies demonstrate that
177Lu-EDTMP is a promising radiopharmaceutical that can be further evaluated for establishing as a radiopharmaceutical for human use. |
| doi_str_mv | 10.1016/j.nucmedbio.2009.09.004 |
| format | Article |
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177Lu [
T
1/2=6.73 days,
E
βmax=497 keV,
E
γ=113 keV (6.4%), 208 keV (11%)]-based radiopharmaceuticals offer logistical advantage for wider use. This paper reports the results of a multispecies biodistribution and toxicity studies of
177Lu-EDTMP to collect preclinical data for starting human clinical trials.
177Lu-EDTMP with radiochemical purity greater than 99% was formulated by using a lyophilized kit of EDTMP (35 mg of EDTMP, 5.72 g of CaO and 14.1 mg of NaOH). Biodistribution studies were conducted in mice and rabbits. Small animal imaging was performed using NanoSPECT/CT (Mediso, Ltd., Hungary) and digital autoradiography. Gamma camera imaging was done in rabbits and dogs. Four levels of activity (9.25 through 37 MBq/kg body weight) of
177Lu-EDTMP were injected in four groups of three dogs each to study the toxicological effects.
177Lu-EDTMP accumulated almost exclusively in the skeletal system (peak ca. 41% of the injected activity in bone with terminal elimination half-life of 2130 and 1870 h in mice and rabbits, respectively) with a peak uptake during 1–3 h. Excretion of the radiopharmaceutical was through the urinary system. Imaging studies showed that all species (mouse, rat, rabbit and dog) take up the compound in regions of remodeling bone, while kidney retention is not visible after 1 day postinjection (pi). In dogs, the highest applied activity (37 MBq/kg body weight) led to a moderate decrease in platelet concentration (mean, 160 g/L) at 1 week pi with no toxicity.
The protracted effective half-life of
177Lu-EDTMP in bone supports that modifying the EDTMP molecule by introducing
177Lu does not alter its biological behaviour as a specific bone-seeking tracer. Species-specific pharmacokinetic behavior differences were observed. Toxicity studies in dogs did not show any biological adverse effects. The studies demonstrate that
177Lu-EDTMP is a promising radiopharmaceutical that can be further evaluated for establishing as a radiopharmaceutical for human use.</description><identifier>ISSN: 0969-8051</identifier><identifier>EISSN: 1872-9614</identifier><identifier>DOI: 10.1016/j.nucmedbio.2009.09.004</identifier><identifier>PMID: 20152721</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Animal studies ; Animals ; Biological and medical sciences ; Bone and Bones - diagnostic imaging ; Bone and Bones - pathology ; Bone and Bones - radiation effects ; Bone seeking radiopharmaceuticals ; Contrast media. Radiopharmaceuticals ; Dogs ; Drug toxicity and drugs side effects treatment ; In vivo biodistribution ; Male ; Medical sciences ; Mice ; Miscellaneous (drug allergy, mutagens, teratogens...) ; Organometallic Compounds - pharmacokinetics ; Organometallic Compounds - therapeutic use ; Organometallic Compounds - toxicity ; Organophosphorus Compounds - pharmacokinetics ; Organophosphorus Compounds - therapeutic use ; Organophosphorus Compounds - toxicity ; Pain - radiotherapy ; Pain Management ; Palliative Care ; Pharmacology. Drug treatments ; Rabbits ; Radionuclide therapy ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Rats ; Small animal imaging ; Technology. Biomaterials. Equipments. Material. Instrumentation ; Tomography, Emission-Computed, Single-Photon ; Tomography, X-Ray Computed</subject><ispartof>Nuclear medicine and biology, 2010-02, Vol.37 (2), p.215-226</ispartof><rights>2010 Elsevier Inc.</rights><rights>2015 INIST-CNRS</rights><rights>(c) 2010 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2451-c070875a0631865cf98fb3b9355d182452f25b7fb7f3e2507cf8046a22f5db323</citedby><cites>FETCH-LOGICAL-c2451-c070875a0631865cf98fb3b9355d182452f25b7fb7f3e2507cf8046a22f5db323</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S096980510900242X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22452516$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20152721$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Máthé, Domokos</creatorcontrib><creatorcontrib>Balogh, Lajos</creatorcontrib><creatorcontrib>Polyák, András</creatorcontrib><creatorcontrib>Király, Réka</creatorcontrib><creatorcontrib>Márián, Teréz</creatorcontrib><creatorcontrib>Pawlak, Dariusz</creatorcontrib><creatorcontrib>Zaknun, John J.</creatorcontrib><creatorcontrib>Pillai, Maroor R.A.</creatorcontrib><creatorcontrib>Jánoki, Győző A.</creatorcontrib><title>Multispecies animal investigation on biodistribution, pharmacokinetics and toxicity of 177Lu-EDTMP, a potential bone pain palliation agent</title><title>Nuclear medicine and biology</title><addtitle>Nucl Med Biol</addtitle><description>Radionuclide therapy (RNT) is an effective method for bone pain palliation in patients suffering from bone metastasis. Due to the long half-life, easy production and relatively low β− energy,
177Lu [
T
1/2=6.73 days,
E
βmax=497 keV,
E
γ=113 keV (6.4%), 208 keV (11%)]-based radiopharmaceuticals offer logistical advantage for wider use. This paper reports the results of a multispecies biodistribution and toxicity studies of
177Lu-EDTMP to collect preclinical data for starting human clinical trials.
177Lu-EDTMP with radiochemical purity greater than 99% was formulated by using a lyophilized kit of EDTMP (35 mg of EDTMP, 5.72 g of CaO and 14.1 mg of NaOH). Biodistribution studies were conducted in mice and rabbits. Small animal imaging was performed using NanoSPECT/CT (Mediso, Ltd., Hungary) and digital autoradiography. Gamma camera imaging was done in rabbits and dogs. Four levels of activity (9.25 through 37 MBq/kg body weight) of
177Lu-EDTMP were injected in four groups of three dogs each to study the toxicological effects.
177Lu-EDTMP accumulated almost exclusively in the skeletal system (peak ca. 41% of the injected activity in bone with terminal elimination half-life of 2130 and 1870 h in mice and rabbits, respectively) with a peak uptake during 1–3 h. Excretion of the radiopharmaceutical was through the urinary system. Imaging studies showed that all species (mouse, rat, rabbit and dog) take up the compound in regions of remodeling bone, while kidney retention is not visible after 1 day postinjection (pi). In dogs, the highest applied activity (37 MBq/kg body weight) led to a moderate decrease in platelet concentration (mean, 160 g/L) at 1 week pi with no toxicity.
The protracted effective half-life of
177Lu-EDTMP in bone supports that modifying the EDTMP molecule by introducing
177Lu does not alter its biological behaviour as a specific bone-seeking tracer. Species-specific pharmacokinetic behavior differences were observed. Toxicity studies in dogs did not show any biological adverse effects. The studies demonstrate that
177Lu-EDTMP is a promising radiopharmaceutical that can be further evaluated for establishing as a radiopharmaceutical for human use.</description><subject>Animal studies</subject><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Bone and Bones - diagnostic imaging</subject><subject>Bone and Bones - pathology</subject><subject>Bone and Bones - radiation effects</subject><subject>Bone seeking radiopharmaceuticals</subject><subject>Contrast media. Radiopharmaceuticals</subject><subject>Dogs</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>In vivo biodistribution</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mice</subject><subject>Miscellaneous (drug allergy, mutagens, teratogens...)</subject><subject>Organometallic Compounds - pharmacokinetics</subject><subject>Organometallic Compounds - therapeutic use</subject><subject>Organometallic Compounds - toxicity</subject><subject>Organophosphorus Compounds - pharmacokinetics</subject><subject>Organophosphorus Compounds - therapeutic use</subject><subject>Organophosphorus Compounds - toxicity</subject><subject>Pain - radiotherapy</subject><subject>Pain Management</subject><subject>Palliative Care</subject><subject>Pharmacology. Drug treatments</subject><subject>Rabbits</subject><subject>Radionuclide therapy</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Rats</subject><subject>Small animal imaging</subject><subject>Technology. Biomaterials. Equipments. Material. Instrumentation</subject><subject>Tomography, Emission-Computed, Single-Photon</subject><subject>Tomography, X-Ray Computed</subject><issn>0969-8051</issn><issn>1872-9614</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc9u1DAQxi0EoqXwCuAL4tIsYyeOk2PVlj_SVnAoZ8tx7DJL1g62U9FX4KlxtEs5In2yJc9vZjzzEfKGwYYBa9_vNn4xezsOGDYcoN-sguYJOWWd5FXfsuYpOYW-7asOBDshL1LaQclsGDwnJxyY4JKzU_L7ZpkyptkatIlqj3s9UfT3NmW80xmDp0WlzYgpRxyW9emczt913GsTfqC3Gc2aOdIcfqHB_ECDo0zK7VJdX93efD2nms4hW5-x1B6Ct3TW6MsxTXhooe9K9CV55vSU7KvjfUa-fbi-vfxUbb98_Hx5sa0MbwSrDEjopNDQ1qxrhXF954Z66GshRtYVhDsuBumKassFSOM6aFrNuRPjUPP6jLw71J1j-LmUQdUek7HTpL0NS1KyrkXTAOsKKQ-kiSGlaJ2aY1lQfFAM1OqD2qlHH9Tqg1oFTcl8feyxDCX8mPd38QV4ewR0MnpyUXuD6R-3ziFYW7iLA2fLRu7RRpWKU97YEaM1WY0B__uZPxvEq9g</recordid><startdate>201002</startdate><enddate>201002</enddate><creator>Máthé, Domokos</creator><creator>Balogh, Lajos</creator><creator>Polyák, András</creator><creator>Király, Réka</creator><creator>Márián, Teréz</creator><creator>Pawlak, Dariusz</creator><creator>Zaknun, John J.</creator><creator>Pillai, Maroor R.A.</creator><creator>Jánoki, Győző A.</creator><general>Elsevier Inc</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>201002</creationdate><title>Multispecies animal investigation on biodistribution, pharmacokinetics and toxicity of 177Lu-EDTMP, a potential bone pain palliation agent</title><author>Máthé, Domokos ; Balogh, Lajos ; Polyák, András ; Király, Réka ; Márián, Teréz ; Pawlak, Dariusz ; Zaknun, John J. ; Pillai, Maroor R.A. ; Jánoki, Győző A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2451-c070875a0631865cf98fb3b9355d182452f25b7fb7f3e2507cf8046a22f5db323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Animal studies</topic><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Bone and Bones - diagnostic imaging</topic><topic>Bone and Bones - pathology</topic><topic>Bone and Bones - radiation effects</topic><topic>Bone seeking radiopharmaceuticals</topic><topic>Contrast media. Radiopharmaceuticals</topic><topic>Dogs</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>In vivo biodistribution</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mice</topic><topic>Miscellaneous (drug allergy, mutagens, teratogens...)</topic><topic>Organometallic Compounds - pharmacokinetics</topic><topic>Organometallic Compounds - therapeutic use</topic><topic>Organometallic Compounds - toxicity</topic><topic>Organophosphorus Compounds - pharmacokinetics</topic><topic>Organophosphorus Compounds - therapeutic use</topic><topic>Organophosphorus Compounds - toxicity</topic><topic>Pain - radiotherapy</topic><topic>Pain Management</topic><topic>Palliative Care</topic><topic>Pharmacology. Drug treatments</topic><topic>Rabbits</topic><topic>Radionuclide therapy</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Rats</topic><topic>Small animal imaging</topic><topic>Technology. Biomaterials. Equipments. Material. Instrumentation</topic><topic>Tomography, Emission-Computed, Single-Photon</topic><topic>Tomography, X-Ray Computed</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Máthé, Domokos</creatorcontrib><creatorcontrib>Balogh, Lajos</creatorcontrib><creatorcontrib>Polyák, András</creatorcontrib><creatorcontrib>Király, Réka</creatorcontrib><creatorcontrib>Márián, Teréz</creatorcontrib><creatorcontrib>Pawlak, Dariusz</creatorcontrib><creatorcontrib>Zaknun, John J.</creatorcontrib><creatorcontrib>Pillai, Maroor R.A.</creatorcontrib><creatorcontrib>Jánoki, Győző A.</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>Nuclear medicine and biology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Máthé, Domokos</au><au>Balogh, Lajos</au><au>Polyák, András</au><au>Király, Réka</au><au>Márián, Teréz</au><au>Pawlak, Dariusz</au><au>Zaknun, John J.</au><au>Pillai, Maroor R.A.</au><au>Jánoki, Győző A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multispecies animal investigation on biodistribution, pharmacokinetics and toxicity of 177Lu-EDTMP, a potential bone pain palliation agent</atitle><jtitle>Nuclear medicine and biology</jtitle><addtitle>Nucl Med Biol</addtitle><date>2010-02</date><risdate>2010</risdate><volume>37</volume><issue>2</issue><spage>215</spage><epage>226</epage><pages>215-226</pages><issn>0969-8051</issn><eissn>1872-9614</eissn><abstract>Radionuclide therapy (RNT) is an effective method for bone pain palliation in patients suffering from bone metastasis. Due to the long half-life, easy production and relatively low β− energy,
177Lu [
T
1/2=6.73 days,
E
βmax=497 keV,
E
γ=113 keV (6.4%), 208 keV (11%)]-based radiopharmaceuticals offer logistical advantage for wider use. This paper reports the results of a multispecies biodistribution and toxicity studies of
177Lu-EDTMP to collect preclinical data for starting human clinical trials.
177Lu-EDTMP with radiochemical purity greater than 99% was formulated by using a lyophilized kit of EDTMP (35 mg of EDTMP, 5.72 g of CaO and 14.1 mg of NaOH). Biodistribution studies were conducted in mice and rabbits. Small animal imaging was performed using NanoSPECT/CT (Mediso, Ltd., Hungary) and digital autoradiography. Gamma camera imaging was done in rabbits and dogs. Four levels of activity (9.25 through 37 MBq/kg body weight) of
177Lu-EDTMP were injected in four groups of three dogs each to study the toxicological effects.
177Lu-EDTMP accumulated almost exclusively in the skeletal system (peak ca. 41% of the injected activity in bone with terminal elimination half-life of 2130 and 1870 h in mice and rabbits, respectively) with a peak uptake during 1–3 h. Excretion of the radiopharmaceutical was through the urinary system. Imaging studies showed that all species (mouse, rat, rabbit and dog) take up the compound in regions of remodeling bone, while kidney retention is not visible after 1 day postinjection (pi). In dogs, the highest applied activity (37 MBq/kg body weight) led to a moderate decrease in platelet concentration (mean, 160 g/L) at 1 week pi with no toxicity.
The protracted effective half-life of
177Lu-EDTMP in bone supports that modifying the EDTMP molecule by introducing
177Lu does not alter its biological behaviour as a specific bone-seeking tracer. Species-specific pharmacokinetic behavior differences were observed. Toxicity studies in dogs did not show any biological adverse effects. The studies demonstrate that
177Lu-EDTMP is a promising radiopharmaceutical that can be further evaluated for establishing as a radiopharmaceutical for human use.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>20152721</pmid><doi>10.1016/j.nucmedbio.2009.09.004</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0969-8051 |
| ispartof | Nuclear medicine and biology, 2010-02, Vol.37 (2), p.215-226 |
| issn | 0969-8051 1872-9614 |
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| subjects | Animal studies Animals Biological and medical sciences Bone and Bones - diagnostic imaging Bone and Bones - pathology Bone and Bones - radiation effects Bone seeking radiopharmaceuticals Contrast media. Radiopharmaceuticals Dogs Drug toxicity and drugs side effects treatment In vivo biodistribution Male Medical sciences Mice Miscellaneous (drug allergy, mutagens, teratogens...) Organometallic Compounds - pharmacokinetics Organometallic Compounds - therapeutic use Organometallic Compounds - toxicity Organophosphorus Compounds - pharmacokinetics Organophosphorus Compounds - therapeutic use Organophosphorus Compounds - toxicity Pain - radiotherapy Pain Management Palliative Care Pharmacology. Drug treatments Rabbits Radionuclide therapy Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Rats Small animal imaging Technology. Biomaterials. Equipments. Material. Instrumentation Tomography, Emission-Computed, Single-Photon Tomography, X-Ray Computed |
| title | Multispecies animal investigation on biodistribution, pharmacokinetics and toxicity of 177Lu-EDTMP, a potential bone pain palliation agent |
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