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BioNano Monographs

Biocompatible Nanomaterials for Targeted and Controlled Delivery of Biomacromolecules

D. Kapoor
D. Kapoor
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S. Dhawan
S. Dhawan
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ASME Press
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All chemical entities that are developed for drug applications, regardless of whether they include nanoscale materials, possess unique characteristics and properties and therefore can, and do, present the FD A with novel challenges. Other than a comprehensive physicochemical characterization of nanoscale containing drugs, pharmacokinetic and biodistribution studies are crucial to help assess the safety and efficacy as well as to estimate clinical doses, dose linearity and species differences of such products [6]. It is important to note that there is a close relationship between the biodistribution profile and the physicochemical properties of the nanoparticles. Therefore, identification of whether nanoparticles can...

9.1 Drug-polymer compatibility
9.2 Particle size and shape
9.3 Zeta potential
9.4 Drug release evaluation
9.5 Conformational stability
9.6 Biocompatibility studies
9.7 Pre-clinical evaluation
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