Literature DB >> 32084321

Emerging Standards and Analytical Science for Nanoenabled Medical Products.

Bryant C Nelson1, Caterina Minelli2, Shareen H Doak3, Matthias Roesslein4.   

Abstract

Development and application of nanotechnology-enabled medical products, including drugs, devices, and in vitro diagnostics, are rapidly expanding in the global marketplace. In this review, the focus is on providing the reader with an introduction to the landscape of commercially available nanotechnology-enabled medical products as well as an overview of the international documentary standards and reference materials that support and facilitate efficient regulatory evaluation and reliable manufacturing of this diverse group of medical products. We describe the materials, test methods, and standards development needs for emerging medical products. Scientific and measurement challenges involved in the development and application of innovative nanoenabled medical products motivate discussion throughout this review.

Entities:  

Keywords:  documentary standards; drug products; in vitro diagnostics; measurement assurance; medical devices; nanomedicine

Mesh：

Substances：

Year:  2020        PMID： 32084321      PMCID： PMC8221451          DOI： 10.1146/annurev-anchem-091619-102216

Source DB:  PubMed          Journal:  Annu Rev Anal Chem (Palo Alto Calif)        ISSN： 1936-1327            Impact factor:   10.745


  76 in total

Review 1.  Nanodiagnostics: application of nanotechnology in molecular diagnostics.

Authors:  K K Jain
Journal:  Expert Rev Mol Diagn       Date:  2003-03       Impact factor: 5.225

Review 2.  Extracellular vesicles: biology and emerging therapeutic opportunities.

Authors:  Samir EL Andaloussi; Imre Mäger; Xandra O Breakefield; Matthew J A Wood
Journal:  Nat Rev Drug Discov       Date:  2013-04-15       Impact factor: 84.694

Review 3.  Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.

Authors:  Daniel Bobo; Kye J Robinson; Jiaul Islam; Kristofer J Thurecht; Simon R Corrie
Journal:  Pharm Res       Date:  2016-06-14       Impact factor: 4.200

4.  Platinum-Decorated Gold Nanoparticles with Dual Functionalities for Ultrasensitive Colorimetric in Vitro Diagnostics.

Authors:  Zhuangqiang Gao; Haihang Ye; Dianyong Tang; Jing Tao; Sanaz Habibi; Adrienne Minerick; Dianping Tang; Xiaohu Xia
Journal:  Nano Lett       Date:  2017-08-18       Impact factor: 11.189

Review 5.  Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success.

Authors:  Jean-Baptiste Coty; Christine Vauthier
Journal:  J Control Release       Date:  2018-02-15       Impact factor: 9.776

6.  Are existing standard methods suitable for the evaluation of nanomedicines: some case studies.

Authors:  Sabrina Gioria; Fanny Caputo; Patricia Urbán; Ciarán Manus Maguire; Susanne Bremer-Hoffmann; Adriele Prina-Mello; Luigi Calzolai; Dora Mehn
Journal:  Nanomedicine (Lond)       Date:  2018-01-30       Impact factor: 5.307

7.  Long-term clinical improvement in MPTP-lesioned primates after gene therapy with AAV-hAADC.

Authors:  Krystof S Bankiewicz; John Forsayeth; Jamie L Eberling; Rosario Sanchez-Pernaute; Philip Pivirotto; John Bringas; Peter Herscovitch; Richard E Carson; William Eckelman; Bryan Reutter; Janet Cunningham
Journal:  Mol Ther       Date:  2006-07-07       Impact factor: 11.454

Review 8.  Cancer nanomedicines: so many papers and so few drugs!

Authors:  Vincent J Venditto; Francis C Szoka
Journal:  Adv Drug Deliv Rev       Date:  2012-10-01       Impact factor: 15.470

9.  Theranostic barcoded nanoparticles for personalized cancer medicine.

Authors:  Zvi Yaari; Dana da Silva; Assaf Zinger; Evgeniya Goldman; Ashima Kajal; Rafi Tshuva; Efrat Barak; Nitsan Dahan; Dov Hershkovitz; Mor Goldfeder; Janna Shainsky Roitman; Avi Schroeder
Journal:  Nat Commun       Date:  2016-11-10       Impact factor: 14.919

Review 10.  Exosome Theranostics: Biology and Translational Medicine.

Authors:  Chuanjiang He; Shu Zheng; Yan Luo; Ben Wang
Journal:  Theranostics       Date:  2018-01-01       Impact factor: 11.556
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  1 in total

1.  Measurement and standardization challenges for extracellular vesicle therapeutic delivery vectors.

Authors:  Bryant C Nelson; Samantha Maragh; Ionita C Ghiran; Jennifer C Jones; Paul C DeRose; Elzafir Elsheikh; Wyatt N Vreeland; Lili Wang
Journal:  Nanomedicine (Lond)       Date:  2020-09-04       Impact factor: 5.307
  1 in total

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