Journal
JOURNAL OF CONTROLLED RELEASE
Volume 146, Issue 2, Pages 164-174Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jconrel.2010.04.008
Keywords
Nanotechnology; Biological potency; Modeling and simulation; Clinical starting dose; Allometry
Funding
- CCR NIH HHS [HHSN261200800001C] Funding Source: Medline
- Intramural NIH HHS [Z99 CA999999] Funding Source: Medline
- NCI NIH HHS [HHSN261200800001E] Funding Source: Medline
Ask authors/readers for more resources
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available