Evidence map›Paper›PMID 41647359›Full record

ReviewFrontiers in bioengineering and biotechnology2026

Regulatory framework for polymer-based nanotherapeutics in clinical translation.

Federico Stucchi, Min Li, Giuseppe Castellano, Francesco Cellesi

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Frontiers in bioengineering and biotechnology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

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  13. Engineering Nanoscale Drug Delivery Systems for Pain.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
    Review
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

4 authors.

Federico StucchiDepartment of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Milan, Italy.
Min LiRenal Research Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Giuseppe CastellanoUnit of Nephrology, Dialysis and Renal Transplant, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Francesco CellesiDepartment of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Polymer-based nanotherapeutics (PNs) have emerged as versatile drug delivery platforms offering controlled release, targeted delivery, and improved pharmacokinetics across therapeutic areas. However, their structural complexity and nanoscale behavior pose significant regulatory challenges. Current frameworks still evaluate PNs under conventional pharmaceutical and biological regulations, overlooking nanospecific properties and leading to case-by-case assessments. This review examines critical quality attributes, analytical requirements, and gaps in standardization that hinder clinical translation. Key issues include inadequate characterization of the physicochemical properties, scalability of manufacturing, and limited predictability of

Indexed as

clinical translationcritical quality attributesnanomedicine policypolymer conjugatespolymeric nanoparticlesquality by bench-to-bedside designregulatory framework

Identifiers

PMID41647359
PMCPMC12868300

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.