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Evaluation of nanomedicines: stick to the basics

Nature Reviews Materials volume 1, Article number: 16073 (2016) Cite this article

The Perspective by Chan and co-workers, (Analysis of nanoparticle delivery to tumours, Nat. Rev. Mater. 1, 16014 (2016))1 continues an important discussion on the effectiveness of nanoparticle-based therapeutics. I note, however, that this retrospective study relies heavily on an unconventional parameter to assess the success or failure of nanomedicine; namely, the average amount of detectable nanoparticle carrier present over time in the tumour tissue.

At the Nanotechnology Characterization Laboratory (NCL), we have conducted over 150 extensive pharmacokinetic (PK) and toxicological preclinical studies for proprietary nanomedicines. NCL studies have found that the ‘nanoparticle in tumour’ parameter does not serve as a good surrogate for therapeutic index, nor does it govern regulatory approval of nanoformulations2. In contrast to the analysis used by Chan and co-workers, evaluation of the nanoparticle's active pharmaceutical ingredient (API; that is, the drug) is the far more relevant consideration and is required to compare critical factors such as PK, toxicity and efficacy among formulations.

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  1. Scott E. McNeil is with the National Cancer Institute's Nanotechnology Characterization Laboratory at the Frederick National Laboratory for Cancer Research, Frederick, Maryland 21702, USA.,

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Correspondence to Scott E. McNeil.

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The author declares no competing interests. Celator Pharmaceuticals, Inc. is a former NCL collaborator.

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McNeil, S. Evaluation of nanomedicines: stick to the basics. Nat Rev Mater 1, 16073 (2016). https://doi.org/10.1038/natrevmats.2016.73

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