Evidence map›Paper›PMID 35908133›Full record

ArticleDrug delivery and translational research2022

Regulatory safety evaluation of nanomedical products: key issues to refine.

Wim H De Jong, Robert E Geertsma, Gerrit Borchard

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug delivery and translational research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing 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

31 citing papers in PubMed.

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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

3 authors.

Wim H De JongFormerly (retired) National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.ORCID 0000-0002-4956-3141
Robert E GeertsmaNational Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.ORCID 0000-0003-0979-9077
Gerrit BorchardUniversity of Geneva, Geneva, Switzerland. Gerrit.Borchard@unige.ch.ORCID 0000-0001-6268-2586

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nanotechnologies enable great opportunities for the development and use of innovative (nano)medicines. As is common for scientific and technical developments, recognized safety evaluation methods for regulatory purposes are lagging behind. The specific properties responsible for the desired functioning also hamper the safety evaluation of such products. Pharmacokinetics determination of the active pharmaceutical ingredient as well as the nanomaterial component is crucial. Due to their particulate nature, nanomedicines, similar to all nanomaterials, are primarily removed from the circulation by phagocytizing cells that are part of the immune system. Therefore, the immune system can be potentially a specific target for adverse effects of nanomedicines, and thus needs special attention during the safety evaluation. This DDTR special issue on the results of the REFINE project on a regulatory science framework for nanomedical products presents a highly valuable body of knowledge needed to address regulatory challenges and gaps in currently available testing methods for the safety evaluation of nanomedicines.

Indexed as

NanomedicineNanostructuresNanotechnologyImmune systemNanomedicinesRegulationsSafety evaluation

Identifiers

PMID35908133
PMCPMC9358921

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.