Evidence map›Paper›PMID 27527889›Full record

ArticleThe AAPS journal2016

Nanomedicines in the EU-Regulatory Overview.

Ruben Pita, Falk Ehmann, Marisa Papaluca

Abstract read
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In one paragraph

Article in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

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  19. Theranostic small interfering RNA nanoparticles in cancer precision nanomedicine.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2020
    Review
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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.

Ruben PitaEuropean Medicines Agency, London, UK. ruben.pita@ema.europa.eu.
Falk EhmannEuropean Medicines Agency, London, UK.
Marisa PapalucaEuropean Medicines Agency, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article provides an overview of the European Union (EU) framework for the marketing authorisation of medicinal products, at both European and National level, and aims to demonstrate the current position and experience with nanomedicines. It will be described how the EU promotes the development of new nanomedicines by publishing guidance, providing scientific advice and engaging with multiple regions for the convergence of scientific requirements to support the quality, safety and efficacy of nanomedicines. It will also be highlighted the regulatory challenges deriving from the use of an innovative technology that crosses different platforms and the importance of overcoming challenges for the benefit of public health.

Indexed as

Legislation, DrugNanomedicineEuropean UnionHumansEMAEUinnovationnanomedicineregulatory science

Identifiers

What OpenQuestion holds

Textmetadata
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.