Translational considerations for cancer nanomedicine
There are many important considerations during preclinical development of cancer nanomedicines, including: 1) unique aspects of animal study design; 2) the difficulties in evaluating biological potency, especially for complex formulations; 3) the importance of analytical methods that can determine p...
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| Veröffentlicht in: | Journal of controlled release 2010-09, Vol.146 (2), p.164-174 |
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| container_title | Journal of controlled release |
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| creator | Stern, Stephan T. Hall, Jennifer B. Yu, Lee L. Wood, Laura J. Paciotti, Giulio F. Tamarkin, Lawrence Long, Stephen E. McNeil, Scott E. |
| description | There are many important considerations during preclinical development of cancer nanomedicines, including: 1) unique aspects of animal study design; 2) the difficulties in evaluating biological potency, especially for complex formulations; 3) the importance of analytical methods that can determine platform stability
in vivo, and differentiate bound and free active pharmaceutical ingredient (API) in biological matrices; and 4) the appropriateness of current dose scaling techniques for estimation of clinical first-in-man dose from preclinical data. Biologics share many commonalities with nanotechnology products with regard to complexity and biological attributes, and can, in some cases, provide context for dealing with these preclinical issues. In other instances, such as the case of
in vivo stability analysis, new approaches are required. This paper will discuss the significance of these preclinical issues, and present examples of current methods and best practices for addressing them. Where possible, these recommendations are justified using the existing regulatory guidance literature.
[Display omitted] |
| doi_str_mv | 10.1016/j.jconrel.2010.04.008 |
| format | Article |
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in vivo, and differentiate bound and free active pharmaceutical ingredient (API) in biological matrices; and 4) the appropriateness of current dose scaling techniques for estimation of clinical first-in-man dose from preclinical data. Biologics share many commonalities with nanotechnology products with regard to complexity and biological attributes, and can, in some cases, provide context for dealing with these preclinical issues. In other instances, such as the case of
in vivo stability analysis, new approaches are required. This paper will discuss the significance of these preclinical issues, and present examples of current methods and best practices for addressing them. Where possible, these recommendations are justified using the existing regulatory guidance literature.
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in vivo, and differentiate bound and free active pharmaceutical ingredient (API) in biological matrices; and 4) the appropriateness of current dose scaling techniques for estimation of clinical first-in-man dose from preclinical data. Biologics share many commonalities with nanotechnology products with regard to complexity and biological attributes, and can, in some cases, provide context for dealing with these preclinical issues. In other instances, such as the case of
in vivo stability analysis, new approaches are required. This paper will discuss the significance of these preclinical issues, and present examples of current methods and best practices for addressing them. Where possible, these recommendations are justified using the existing regulatory guidance literature.
[Display omitted]</description><subject>Allometry</subject><subject>Animals</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - pharmacokinetics</subject><subject>Biological and medical sciences</subject><subject>Biological potency</subject><subject>Clinical starting dose</subject><subject>Drug Evaluation, Preclinical - methods</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Modeling and simulation</subject><subject>Models, Biological</subject><subject>Nanomedicine</subject><subject>Nanostructures - administration & dosage</subject><subject>Nanotechnology</subject><subject>Neoplasms - drug therapy</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Rabbits</subject><subject>Rats</subject><subject>Rats, Sprague-Dawley</subject><issn>0168-3659</issn><issn>1873-4995</issn><issn>1873-4995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkctOAyEUhonRaL08gqYb42rqYYAZ2GiM8ZaYuNE1QeagNFNQmJr49lJbbytXBPjOfw58hOxTmFCgzfF0MrUxJOwnNZQz4BMAuUZGVLas4kqJdTIqnKxYI9QW2c55CgCC8XaTbNXApKCSjQi_Tybk3gw-BtOPS2T2HabPfR67mMbWBItpHEyIM-y89QF3yYYzfca91bpDHi4v7s-vq9u7q5vzs9vKiloOleMIDee8rUUrwIF1tXDCgVGdtYbyRiBXwDvn6pY5Z4Ajl9g1LTihnO3YDjlZ5r7MH0tvi2FIptcvyc9MetfReP33Jvhn_RTfdK1q2jBVAo5WASm-zjEPeuazxb43AeM861ZwqbiU4n-ygAtYFlIsSZtizgnd9zwU9EKNnuqVGr1Qo4HroqbUHfx-zHfVl4sCHK4Ak63pXRFjff7hGFXQsqZwp0sOy9e_eUw6W49FUucT2kF30f8zygcg0LC7</recordid><startdate>20100901</startdate><enddate>20100901</enddate><creator>Stern, Stephan T.</creator><creator>Hall, Jennifer B.</creator><creator>Yu, Lee L.</creator><creator>Wood, Laura J.</creator><creator>Paciotti, Giulio F.</creator><creator>Tamarkin, Lawrence</creator><creator>Long, Stephen E.</creator><creator>McNeil, Scott E.</creator><general>Elsevier B.V</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><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20100901</creationdate><title>Translational considerations for cancer nanomedicine</title><author>Stern, Stephan T. ; Hall, Jennifer B. ; Yu, Lee L. ; Wood, Laura J. ; Paciotti, Giulio F. ; Tamarkin, Lawrence ; Long, Stephen E. ; McNeil, Scott E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c528t-f4e06444725750f0cf25f5f0a9dcca1465e4904dff273ffa04e48ed670f59fcd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Allometry</topic><topic>Animals</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - pharmacokinetics</topic><topic>Biological and medical sciences</topic><topic>Biological potency</topic><topic>Clinical starting dose</topic><topic>Drug Evaluation, Preclinical - methods</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Modeling and simulation</topic><topic>Models, Biological</topic><topic>Nanomedicine</topic><topic>Nanostructures - administration & dosage</topic><topic>Nanotechnology</topic><topic>Neoplasms - drug therapy</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Rabbits</topic><topic>Rats</topic><topic>Rats, Sprague-Dawley</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stern, Stephan T.</creatorcontrib><creatorcontrib>Hall, Jennifer B.</creatorcontrib><creatorcontrib>Yu, Lee L.</creatorcontrib><creatorcontrib>Wood, Laura J.</creatorcontrib><creatorcontrib>Paciotti, Giulio F.</creatorcontrib><creatorcontrib>Tamarkin, Lawrence</creatorcontrib><creatorcontrib>Long, Stephen E.</creatorcontrib><creatorcontrib>McNeil, Scott E.</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><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of controlled release</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stern, Stephan T.</au><au>Hall, Jennifer B.</au><au>Yu, Lee L.</au><au>Wood, Laura J.</au><au>Paciotti, Giulio F.</au><au>Tamarkin, Lawrence</au><au>Long, Stephen E.</au><au>McNeil, Scott E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Translational considerations for cancer nanomedicine</atitle><jtitle>Journal of controlled release</jtitle><addtitle>J Control Release</addtitle><date>2010-09-01</date><risdate>2010</risdate><volume>146</volume><issue>2</issue><spage>164</spage><epage>174</epage><pages>164-174</pages><issn>0168-3659</issn><issn>1873-4995</issn><eissn>1873-4995</eissn><coden>JCREEC</coden><abstract>There are many important considerations during preclinical development of cancer nanomedicines, including: 1) unique aspects of animal study design; 2) the difficulties in evaluating biological potency, especially for complex formulations; 3) the importance of analytical methods that can determine platform stability
in vivo, and differentiate bound and free active pharmaceutical ingredient (API) in biological matrices; and 4) the appropriateness of current dose scaling techniques for estimation of clinical first-in-man dose from preclinical data. Biologics share many commonalities with nanotechnology products with regard to complexity and biological attributes, and can, in some cases, provide context for dealing with these preclinical issues. In other instances, such as the case of
in vivo stability analysis, new approaches are required. This paper will discuss the significance of these preclinical issues, and present examples of current methods and best practices for addressing them. Where possible, these recommendations are justified using the existing regulatory guidance literature.
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| ispartof | Journal of controlled release, 2010-09, Vol.146 (2), p.164-174 |
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| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Allometry Animals Antineoplastic Agents - administration & dosage Antineoplastic Agents - pharmacokinetics Biological and medical sciences Biological potency Clinical starting dose Drug Evaluation, Preclinical - methods General pharmacology Humans Medical sciences Modeling and simulation Models, Biological Nanomedicine Nanostructures - administration & dosage Nanotechnology Neoplasms - drug therapy Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Rabbits Rats Rats, Sprague-Dawley |
| title | Translational considerations for cancer nanomedicine |
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