european medicines agency (ema)

What are the Challenges in Evaluating Nanomedicines?

Evaluating nanomedicines poses unique challenges due to their complex structures and behaviors at the nanoscale. Some of the main challenges include:
Characterization: Comprehensive characterization of nanoparticles is essential to understand their properties and behaviors in biological systems.
Toxicology: Nanoparticles may exhibit different toxicological profiles compared to their bulk counterparts, necessitating thorough toxicological assessments.
Regulatory Pathways: The regulatory pathways for nanomedicines can be complex, requiring collaboration between multidisciplinary teams and regulatory authorities.

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