ArticleMaterials (Basel, Switzerland)2020
Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products.
Article in Materials (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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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.
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.
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Who cites it
19 citing papers in PubMed.
- Nano-warfare in the oral cavity: antimicrobial strategies and mechanisms in nanodentistry.Odontology · 2026Review
- Biogenic Selenium Nanoparticles Functionalized with Natural Polymers or Phytochemicals for Targeted Disruption ofJournal of functional biomaterials · 2026Review
- Advanced Drug Delivery Strategies for Overcoming Biological Barriers: Tumor Microenvironment and Blood-Brain Barrier.Drugs in R&D · 2026Review
- Key attributes of health and environmental risk decision-making: A scoping review.Risk analysis : an official publication of the Society for Risk Analysis · 2025Article
- Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science.Bioactive materials · 2025Review
- From innovation to application: safety concerns in nanomaterial implant coatings.Nanomedicine (London, England) · 2025Article
- Emerging biomaterials and bio-nano interfaces in pulmonary hypertension therapy: transformative strategies for personalized treatment.Frontiers in bioengineering and biotechnology · 2025Review
- On the lifespan ofAging · 2024Article
- Iron Oxide (Magnetite)-Based Nanobiomaterial with Medical Applications-Environmental Hazard Assessment Using Terrestrial Model Species.Journal of xenobiotics · 2024Article
- Nanomaterial genotoxicity evaluation using the high-throughput p53-binding protein 1 (53BP1) assay.PloS one · 2023Article
- Review
- Surface Engineering of Nanomaterials with Polymers, Biomolecules, and Small Ligands for Nanomedicine.Materials (Basel, Switzerland) · 2022Review
- Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies.Pharmaceutics · 2022Review
- Identification of the safe(r) by design alternatives for nanosilver-enabled wound dressings.Frontiers in bioengineering and biotechnology · 2022Article
- Pre-validation of a reporter gene assay for oxidative stress for the rapid screening of nanobiomaterials.Frontiers in toxicology · 2022Article
- Understanding the Role and Impact of Poly (Ethylene Glycol) (PEG) on Nanoparticle Formulation: Implications for COVID-19 Vaccines.Frontiers in bioengineering and biotechnology · 2022Review
- Identifying diverse metal oxide nanomaterials with lethal effects on embryonic zebrafish using machine learning.Beilstein journal of nanotechnology · 2021Article
- ASINA Project: Towards a Methodological Data-Driven Sustainable and Safe-by-Design Approach for the Development of Nanomaterials.Frontiers in bioengineering and biotechnology · 2021Article
- Innovative Antimicrobial Chitosan/ZnO/Ag NPs/Citronella Essential Oil Nanocomposite-Potential Coating for Grapes.Foods (Basel, Switzerland) · 2020Article
Corrections and comments
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Authors and funding
26 authors.
Funding
Abstract
The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.
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Registered trials
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.