Results 41 to 50 of about 7,238,985 (145)
Regulatory safety aspects of advanced therapy medicinal products (ATMPs)
, 2020 Advanced therapy medicinal products (ATMPs) such as gene-, cell- and tissue engineered therapies offer tremendous potential for treating unmet medical needs.
Wilk-Zasadna, Iwona
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Frontiers in Pharmacology, 2021 Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved
Carolina Iglesias-Lopez +5 more
doaj +1 more source
Therapeutic Proteins and Advanced Therapy Medicinal Products [PDF]
, 2023 This chapter is divided in two parts: Therapeutic proteins and Advanced Therapy Medicinal Products (ATMPs). Therapeutic Proteins. Therapeutic proteins are large molecules that are different from low molecular weight medicines.
Black, Anne +6 more
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Cell‐Based Biohybrid Micro/Nanorobots for Biotherapy
Advanced Robotics Research, EarlyView.This review systematically evaluates cell‐based biohybrid micro/nanorobots (CB‐BMRs), highlighting their cell selection criteria, fabrication strategies, and diverse actuation modes. Furthermore, it surveys the promising therapeutic applications of CB‐BMRs in targeted cancer, thrombosis, and inflammation treatments, while comprehensively discussing ...
Lin Wang +11 more
wiley +1 more source
Therapeutic Advances in Vaccines and Immunotherapy, 2020 Advanced Therapy Medicinal Products (ATMPs) comprise novel cell, tissue and gene therapies and offer the potential of durable remissions for diseases where there is a high unmet clinical need.
Manon Pillai +2 more
doaj +1 more source
Frontiers in Immunology, 2022 MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years.
Maria Eugenia Fernández-Santos +25 more
doaj +1 more source
Advanced Intelligent Systems, EarlyView.This review highlights recent advances in automated iPSC culture systems integrating robotics, advanced imaging, artificial intelligence, and process control. These technologies improve reproducibility, scalability, and quality in cell expansion, differentiation, and real‐time monitoring, while emerging AI‐enabled and closed‐loop approaches offer new ...
Hyoryong Lee +3 more
wiley +1 more source
How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU
British Journal of Clinical Pharmacology, EarlyView.The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley +1 more source
Precision medicine in paediatrics: Progress and priorities
British Journal of Clinical Pharmacology, EarlyView.Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain +3 more
wiley +1 more source
Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe
British Journal of Clinical Pharmacology, EarlyView.Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis +4 more
wiley +1 more source