Article | REF: NM4040 V1

Nanotoxicology and nanomedicine regulation

Authors: Elias FATTAL, Hervé HILLAIREAU

Publication date: April 10, 2020

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7. Conclusion

Like all other drugs, nanomedicines must undergo a cycle of preclinical and clinical studies, not only from a pharmacological point of view, but also from a toxicological one. The question of toxicity is essential, but must be dissociated from the very general issue of nanotechnology toxicity. However, they cannot be considered as generic drugs for very conventional injectable suspensions.

The dossier must contain a complete characterization of the nanomedicine. The manufacturing process must be industrially transposable and enable the nanoparticles' initial characteristics to be reproduced. Pharmacokinetics, biodistribution, elimination and toxicity in relation to target organs and cells must be studied. The notion of benefit-risk and the reversibility of toxic effects are two particularly important points that should also be taken into account.

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