Gobernanza de la nanomedicina: una revisión sistemática

Soto-Vazquez, Roberto; Lau, Edgar Záyago; Maldonado-López, Luis

doi:10.22201/ceiich.24485691e.2022.28.69682

Cited by 4 publications

(4 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, there is no specific basis for developing and implementing a regulatory framework for nanomedicine. Risk assessment approaches are still incomplete and international regulations that are feasible to apply to the region continue to be used [396].…”

Section: Regulation For Nps In Latin Americamentioning

confidence: 99%

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

et al. 2022

View full text Add to dashboard Cite

Nanomedicine plays an essential role in developing new therapies through novel drug delivery systems, diagnostic and imaging systems, vaccine development, antibacterial tools, and high-throughput screening. One of the most promising drug delivery systems are nanoparticles, which can be designed with various compositions, sizes, shapes, and surface modifications. These nanosystems have improved therapeutic profiles, increased bioavailability, and reduced the toxicity of the product they carry. However, the clinical translation of nanomedicines requires a thorough understanding of their properties to avoid problems with the most questioned aspect of nanosystems: safety. The particular physicochemical properties of nano-drugs lead to the need for additional safety, quality, and efficacy testing. Consequently, challenges arise during the physicochemical characterization, the production process, in vitro characterization, in vivo characterization, and the clinical stages of development of these biopharmaceuticals. The lack of a specific regulatory framework for nanoformulations has caused significant gaps in the requirements needed to be successful during their approval, especially with tests that demonstrate their safety and efficacy. Researchers face many difficulties in establishing evidence to extrapolate results from one level of development to another, for example, from an in vitro demonstration phase to an in vivo demonstration phase. Additional guidance is required to cover the particularities of this type of product, as some challenges in the regulatory framework do not allow for an accurate assessment of NPs with sufficient evidence of clinical success. This work aims to identify current regulatory issues during the implementation of nanoparticle assays and describe the major challenges that researchers have faced when exposing a new formulation. We further reflect on the current regulatory standards required for the approval of these biopharmaceuticals and the requirements demanded by the regulatory agencies. Our work will provide helpful information to improve the success of nanomedicines by compiling the challenges described in the literature that support the development of this novel encapsulation system. We propose a step-by-step approach through the different stages of the development of nanoformulations, from their design to the clinical stage, exemplifying the different challenges and the measures taken by the regulatory agencies to respond to these challenges.

show abstract

Section: Regulation For Nps In Latin Americamentioning

confidence: 99%

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

et al. 2022

View full text Add to dashboard Cite

show abstract

“…El enfoque descendente de las tecnologías derivadas de la industria microelectrónica para reducir las dimensiones de los circuitos integrados es considerablemente diferente del enfoque ascendente de los programas de inspiración química destinados a la fabricación de nano-objetos funcionalizados, átomo por átomo (VINCK; HUBERT, 2017;BERGER et al, 2021). Esos dos enfoques difieren también de los programas de nanomedicina destinados a vectorizar los medicamentos para que lleguen sólo a las células enfermas (LOUVEL, 2020;SOTO-VAZQUEZ et al, 2022) o de los proyectos destinados a la fabricación de nanomáquinas moleculares. Sin embargo, una escala común, el nanómetro, reúne este conjunto de investigaciones bajo la misma categoría, ya que, en todos los casos, se trata de manipular la materia en la escala nanométrica.…”

Section: El Futuro Abierto De Las Nanotecnologiasunclassified

Entre proyecciones a futuro e incertidumbre: el conocimiento anticipatorio en el desarrollo de dos sectores tecnológicos en Argentina

Hubert

2022

R. Tecnol. Soc.

View full text Add to dashboard Cite

The future, as an object of knowledge and action, constitutes a crucial dimension of scientific and technological activities. The present article analyses the role of "anticipatory knowledge" -i.e. knowledge about the future-in the cases of two technological sectors in Argentina: energy technologies and nanotechnologies. The comparative analysis enables the identification of two micro-regimes of anticipatory knowledge. In the case of energy technologies, anticipatory knowledge works as a governance tool that allows for the comparative assessment of technical options and the definition of investment priorities which depends on political considerations and an assembly of indicators and planning techniques (models and scenarios). In the case of nanotechnologies, on the other hand, the anticipatory knowledge that guides the present actions presents a much higher level of imprecision, since it requires that scientists and technologists project potential applications that they cannot define precisely. However, it constitutes a strategic resource that gives coherence to the multiple lines of research and STI policy actions that structure the technoscientific communities of this emerging field.

show abstract

“…La globalización permitió disponer de recursos en la centralidad económica donde se aglomeran las instituciones y organizaciones que deciden sobre las transferencias de recursos (Soto -Vázquez et al, 2021). Desde la periferia, los recursos se trasladaban, tras su transformación en productos en la semiperiferia industrial, hacia la centralidad de las ciudades (Bourdieu, 1985).…”

Section: Introductionunclassified

Modelo factorial exploratorio de la gobernanza ecocéntrica en la era COVID-19

Carreón-Guillén

Aguayo

Lirios

2023

AJAYU

View full text Add to dashboard Cite

En este artículo se establecen las diferencias entre la gobernanza antropocéntrica y la gobernanza ecocéntrica en la gestión de los recursos y servicios energéticos e hídricos. Se realizó un estudio exploratorio, transversal y psicométrico con una selección no probabilística de 100 funcionarios y usuarios del servicio de luz y agua. Se utilizó el Inventario de Gobernanza de Carreón Guillén (2022) y se obtuvieron los tres factores preponderantes: conflicto, negociación-consenso y autorregulación-corresponsabilidad. En relación con el escenario de escasez de recursos, se discuten las aplicaciones para el diseño de políticas energéticas y de agua basadas en tarifas acordes a la escasez de recursos.

show abstract

Gobernanza de la nanomedicina: una revisión sistemática

Cited by 4 publications

References 38 publications

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

Entre proyecciones a futuro e incertidumbre: el conocimiento anticipatorio en el desarrollo de dos sectores tecnológicos en Argentina

Modelo factorial exploratorio de la gobernanza ecocéntrica en la era COVID-19

Contact Info

Product

Resources

About