Translational considerations for cancer nanomedicine

JOURNAL OF CONTROLLED RELEASE

卷:146

Article; Proceedings Paper

Stern, Stephan T.¹  Hall, Jennifer B.¹  Yu, Lee L.²  Wood, Laura J.²  Paciotti, Giulio F.³  Tamarkin, Lawrence³  Long, Stephen E.²  McNeil, Scott E.¹ 

[1] NCI, Nanotechnol Characterizat Lab, Adv Technol Program, SAIC Frederick Inc, Frederick, MD 21702 USA

[2] NIST, Gaithersburg, MD 20899 USA

[3] CytImmune Sci, Rockville, MD 20850 USA

关键词: Nanotechnology;    Biological potency;    Modeling and simulation;    Clinical starting dose;    Allometry;   

DOI  :  10.1016/j.jconrel.2010.04.008

来源: Elsevier

【 摘 要 】

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. (C) 2010 Elsevier B.V. All rights reserved.

【 授权许可】

Free