Evidence map›Paper›PMID 37718353›Full record

ArticleAdvanced healthcare materials2023

Feeding Next-Generation Nanomedicines to Europe: Regulatory and Quality Challenges.

Umberto M Musazzi, Silvia Franzè, Fabrizio Condorelli, Paola Minghetti, Paolo Caliceti

Abstract read
In one paragraph

Article in Advanced healthcare materials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed.

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  9. Tableting of nanoparticle-based formulations for oral delivery: Enhancing biopharmaceutical performance.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
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  19. Recent advances and future challenges in nanosystems for ocular drug delivery.The Journal of pharmacology and experimental therapeutics · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Umberto M MusazziDepartment of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, Milan, 71-20133, Italy.ORCID 0000-0002-7049-4152
Silvia FranzèDepartment of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, Milan, 71-20133, Italy.ORCID 0000-0003-2231-031X
Fabrizio CondorelliDepartment of Pharmaceutical Sciences, Università degli Studi del Piemonte Orientale, Largo Donegani, Novara, 2-28100, Italy.ORCID 0000-0002-9943-0857
Paola MinghettiDepartment of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, Milan, 71-20133, Italy.ORCID 0000-0001-7723-441X
Paolo CalicetiDepartment of Pharmaceutical and Pharmacological Sciences, University of Padova, via F. Marzolo, Padova, 5-35131, Italy.ORCID 0000-0002-2222-9944

Funding

European Union-NextGenerationEU PNRRM4C2-Investimento1.4-CN00000041-PNRR_CN3RNA_SPOKE9
6 · The paper itself

Abstract

New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.

Indexed as

Artificial IntelligenceNanomedicineEuropeHumansNanotechnologynanomaterialsnanomedicinesphysicochemical characterizationquality attributeregulatory science

Identifiers

PMID37718353
PMCPMC11468706

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.