Evidence map›Paper›PMID 32053962›Full record

ReviewPharmaceutics2020

Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU.

Eliana B Souto, Gabriela F Silva, João Dias-Ferreira, Aleksandra Zielinska, Fátima Ventura, Alessandra Durazzo, Massimo Lucarini, Ettore Novellino, Antonello Santini

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
–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

63 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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3 more citing papers are in PubMed but not listed here.

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

9 authors.

Eliana B SoutoDepartment of Pharmaceutical Technology, Faculty of Pharmacy (FFUC), University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Gabriela F SilvaDepartment of Pharmaceutical Technology, Faculty of Pharmacy (FFUC), University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
João Dias-FerreiraDepartment of Pharmaceutical Technology, Faculty of Pharmacy (FFUC), University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Aleksandra ZielinskaDepartment of Pharmaceutical Technology, Faculty of Pharmacy (FFUC), University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Fátima VenturaDepartment of Biochemistry and Human Biology, Faculty of Pharmacy, University of Lisbon, 1649-003 Lisbon, Portugal.
Alessandra DurazzoCREA-Research Centre for Food and Nutrition, Via Ardeatina 546, 00178 Rome, Italy.
Massimo LucariniCREA-Research Centre for Food and Nutrition, Via Ardeatina 546, 00178 Rome, Italy.
Ettore NovellinoDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Napoli, Italy.
Antonello SantiniDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Napoli, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the "Holy Grail" of medicine-nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here.

Indexed as

clinical trialsGMPlegislationnanopharmaceuticsqualitysafety

Identifiers

PMID32053962
PMCPMC7076491

What OpenQuestion 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 OpenQuestion graph.