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LINK . SPRINGER . COM {}

Detected CMS Systems:

  1. Analyzed Page
  2. Matching Content Categories
  3. CMS
  4. Monthly Traffic Estimate
  5. How Does Link.springer.com Make Money
  6. Wordpress Themes And Plugins
  7. Keywords
  8. Topics
  9. Questions
  10. Schema
  11. External Links
  12. Analytics And Tracking
  13. Libraries
  14. CDN Services

We are analyzing https://link.springer.com/article/10.1007/s13346-021-01024-2.

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
Website Age:
28 years and 1 months (reg. 1997-05-29).

Matching Content Categories {📚}

  • Education
  • Science
  • Environment

Content Management System {📝}

What CMS is link.springer.com built with?


Link.springer.com is built with WORDPRESS.

Traffic Estimate {📈}

What is the average monthly size of link.springer.com audience?

🌠 Phenomenal Traffic: 5M - 10M visitors per month


Based on our best estimate, this website will receive around 5,000,019 visitors per month in the current month.
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How Does Link.springer.com Make Money? {💸}

We're unsure if the website is profiting.

Websites don't always need to be profitable; some serve as platforms for education or personal expression. Websites can serve multiple purposes. And this might be one of them. Link.springer.com might be plotting its profit, but the way they're doing it isn't detectable yet.

Wordpress Themes and Plugins {🎨}

What WordPress theme does this site use?

It is strange but we were not able to detect any theme on the page.

What WordPress plugins does this website use?

It is strange but we were not able to detect any plugins on the page.

Keywords {🔍}

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?

Schema {🗺️}

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         headline:Current hurdles to the translation of nanomedicines from bench to the clinic
         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.
         datePublished:2021-07-23T00:00:00Z
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      headline:Current hurdles to the translation of nanomedicines from bench to the clinic
      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.
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      dateModified:2021-07-23T00:00:00Z
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         Regulatory framework
         Manufacturing
         Scale-up
         Characterization
         Pharmaceutical Sciences/Technology
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                     name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
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                  address:
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                     type:PostalAddress
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            type:Person
            name:Barbara Carreira
            affiliation:
                  name:Universidade de Lisboa, Avenida Professor Gama Pinto
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                     name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
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                     type:PostalAddress
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                     name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
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                     type:PostalAddress
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                  type:Organization
            email:[email protected]
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            name:Helena F. Florindo
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                  name:Universidade de Lisboa, Avenida Professor Gama Pinto
                  address:
                     name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
                     type:PostalAddress
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               name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
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               name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
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      name:Barbara Carreira
      affiliation:
            name:Universidade de Lisboa, Avenida Professor Gama Pinto
            address:
               name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
               type:PostalAddress
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      affiliation:
            name:Tel Aviv University
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               name:Department of Physiology and Pharmacology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
               type:PostalAddress
            type:Organization
      name:Rita C. Acúrcio
      affiliation:
            name:Universidade de Lisboa, Avenida Professor Gama Pinto
            address:
               name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
               type:PostalAddress
            type:Organization
      name:Ronit Satchi-Fainaro
      affiliation:
            name:Tel Aviv University
            address:
               name:Department of Physiology and Pharmacology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
               type:PostalAddress
            type:Organization
            name:Sagol School of Neuroscience, Tel Aviv University
            address:
               name:Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:Helena F. Florindo
      affiliation:
            name:Universidade de Lisboa, Avenida Professor Gama Pinto
            address:
               name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:María J. Vicent
      url:http://orcid.org/0000-0001-7771-3373
      affiliation:
            name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF)
            address:
               name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
               type:PostalAddress
            type:Organization
      email:[email protected]
PostalAddress:
      name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
      name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
      name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain
      name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
      name:Department of Physiology and Pharmacology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
      name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
      name:Department of Physiology and Pharmacology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
      name:Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel
      name:Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, Lisboa, Portugal
      name:Polymer Therapeutics Laboratory, Prince Felipe Research Center (CIPF), Valencia, Spain

External Links {🔗}(376)

Analytics and Tracking {📊}

  • Google Tag Manager

Libraries {📚}

  • Clipboard.js
  • Particles.js
  • Prism.js

CDN Services {📦}

  • Crossref

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