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Translational Considerations for Cancer Nanomedicine



Stephen T. Stern, Jennifer B. Hall, Lee L. Yu, Laura J. Wood, Giulio F. Paciotti, Lawrence Tamarkin, Stephen E. Long, Scott E. McNeil


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 platform 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.
Clinical Cancer Research


"nanomedicine, ", "cancer", "gold", "nanoparticle", "tumer necrosis factor", "pharmacokinetic model"


Stern, S. , Hall, J. , Yu, L. , Wood, L. , Paciotti, G. , Tamarkin, L. , Long, S. and McNeil, S. (2010), Translational Considerations for Cancer Nanomedicine, Clinical Cancer Research, [online], (Accessed May 25, 2024)


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Created August 31, 2010, Updated October 12, 2021