Evidence map›Paper›PMID 31933006›Full record

ReviewAAPS PharmSciTech2020

Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory "Astrolabe" Inspired System.

Costas Demetzos, Paraskevi Kavatzikidou, Natassa Pippa, Emmanuel Stratakis

Abstract readReview
PubMed Publisher
In one paragraph

Review in AAPS PharmSciTech, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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.

Costas DemetzosSchool of Health Sciences, Department of Pharmacy, Laboratory of Pharmaceutical Technology, Section of Pharmaceutical Nanotechnology, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, 15775, Athens, Greece. demetzos@pharm.uoa.gr.
Paraskevi KavatzikidouIESL, FORTH, Crete, Greece.
Natassa PippaSchool of Health Sciences, Department of Pharmacy, Laboratory of Pharmaceutical Technology, Section of Pharmaceutical Nanotechnology, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, 15775, Athens, Greece.
Emmanuel StratakisIESL, FORTH, Crete, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The application of the nanotechnology in medicine and pharmaceutics opens new horizons in therapeutics. Several nanomedicines are in the market and an increasing number is in clinical trials. But which is the advantage of the medicines in nanoscale? The scientists and the regulatory authorities agree that the size and consequently the physiochemical/biological properties of nanomaterials play a key role in their safety and effectiveness. Additionally, all of them agree that a new scientific-based regulatory landscape is required for the establishment of nanomedicines in the market. The aim of this review is to investigate the parameters that the scientists and the regulatory authorities should take into account in order to build up a dynamic regulatory landscape for nanomedicines. For this reason, we propose an "astrolabe-like system" as the guide for establishing the regulatory approval process. Its function is based on the different physicochemical/biological properties in comparison to low molecular weight drugs.

Indexed as

Biosimilar PharmaceuticalsDrug and Narcotic ControlDrug ApprovalHumansNanomedicineBiosimilar Pharmaceuticalsastrolabecomplex drugsnanomedicinesnanosimilarsregulatory issues

Identifiers

PMID31933006

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.