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Title:
Current hurdles to the translation of nanomedicines from bench to the clinic | Drug Delivery and Translational Research
Description:
The field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract
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drug, nanomedicine, nanomedicines, regulatory, development, products, clinical, article, studies, characterization, safety, google, scholar, product, quality, models, vivo, biological, cas, preclinical, manufacturing, stability, pubmed, guidelines, fda, size, control, nanoparticles, translation, european, research, properties, cancer, methods, human, release, challenges, process, analysis, analytical, nanotechnology, parameters, evaluation, vitro, specific, particle, design, httpsdoiorg, data, include,
Topics {✒️}
eu/en/documents/scientific-guideline/draft-joint-ministry-health-labour-welfare/european-medicines-agency-reflection-paper-development-block-copolymer-micelle-medicinal-products_en eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-iron-based-nano-colloidal-products-developed_en eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-liposomal-products-developed-reference-innovator_en eu/en/documents/presentation/presentation-nanomedicines-current-initiatives-canada-duc-vu-health-canada_en eu/en/documents/assessment-report/onpattro-epar-public-assessment-report_ ca/en/health-canada/services/drugs-health-products/nanotechnology-based-health-products-food eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-nanomedicines halamoda-kenzaoui databases/inactive-ingredients-approved-drug-products-search-frequently-asked-questions grassiri eu/en/development-block-copolymer-micelle-medicinal-products ema gov/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm071836 gnoth /wp-content/uploads/pdfs/onpattro-fact-sheet gov/files/drugs/published/drug-products--including-biological-products /assay-cascade/pdfs/pcc/euncl-pcc-022 /news-release/2017/07/27/1063532/0/en/global-api-management-market gov/resources/assay-cascade-protocols bremer org/articles/92/i45/closing-gap-generic-nanomedicines org/wp-content/uploads/2015/08/pdf/presentation_sadrieh small-angle x-ray scattering /sites/default/files/uploadfiles/guidelines_for_evaluation_of_nanopharmaceuticals_in_india_24 eu/pt/legislation/directives/regulation-ec org/sti/emerging-tech/ %0a[accessed /-/media/files/corporate/publications/2010/10/nanomedicinesregulatory 111in-dtpa-labelled pegylated liposomes asymmetric-flow field-flow fractionation ncl recommends lc–ms/ms vis-fld visible-fluorescence detector 64cu-labeled her2-targeted liposomes frequently asked questions /featured-articles/353977-calculating-endotoxin-limits eu/pt/regulations/nanomaterials schoonjans subgroup-dependent physico-chemical properties nanotechnology-based health products nanotechnology-enabled health products hplc include uv–vis standard care/gold-standard treatments /retrieve/pii/s0169409x17300273 pozzi /retrieve/pii/s0378517321002568 kurakula /retrieve/pii/s0939641119302516 wei liposome-based drug products rna interference-based lipoplex sec size-exclusion chromatography reflection paper preparing guidance documents regulatory guidance documents /retrieve/pii/s1773224720313356 dahlgren density-changing centrifugation method gov/media/70837/download tyner /retrieve/pii/s0169409x2100096x ofek categorize nanotechnology-based concerns dimensional spheroid/organoid cultures
Questions {❓}
- Believe it or not: how much can we rely on published data on potential drug targets?
- Could 3D models of cancer enhance drug screening?
- Meet me halfway: are in vitro 3D cancer models on the way to replace in vivo models for nanomedicine development?
- Nanomedicines: the magic bullets reaching their target?
- Regulating nanomedicine—can the FDA Handle It?
- Regulatory challenges of nanomedicines and their follow-on versions: a generic or similar approach?
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