Literature DB >> 24673240

Nanomedicines: addressing the scientific and regulatory gap.

Sally Tinkle1, Scott E McNeil, Stefan Mühlebach, Raj Bawa, Gerrit Borchard, Yechezkel Chezy Barenholz, Lawrence Tamarkin, Neil Desai.   

Abstract

Nanomedicine is the application of nanotechnology to the discipline of medicine: the use of nanoscale materials for the diagnosis, monitoring, control, prevention, and treatment of disease. Nanomedicine holds tremendous promise to revolutionize medicine across disciplines and specialties, but this promise has yet to be fully realized. Beyond the typical complications associated with drug development, the fundamentally different and novel physical and chemical properties of some nanomaterials compared to materials on a larger scale (i.e., their bulk counterparts) can create a unique set of opportunities as well as safety concerns, which have only begun to be explored. As the research community continues to investigate nanomedicines, their efficacy, and the associated safety issues, it is critical to work to close the scientific and regulatory gaps to assure that nanomedicine drives the next generation of biomedical innovation.
© 2014 New York Academy of Sciences.

Keywords:  Abbreviated New Drug Application (ANDA); bioequivalence; biosimilars; follow-on biologics; immunogenicity; nanomedicine; nanopharmaceuticals; nanosimilars; nanotechnology; non-biologic complex drug (NBCD); patents; pharmacodynamics; pharmacokinetics; regulation

Mesh:

Year:  2014        PMID: 24673240     DOI: 10.1111/nyas.12403

Source DB:  PubMed          Journal:  Ann N Y Acad Sci        ISSN: 0077-8923            Impact factor:   5.691


  62 in total

1.  Defining Nano, Nanotechnology and Nanomedicine: Why Should It Matter?

Authors:  Priya Satalkar; Bernice Simone Elger; David M Shaw
Journal:  Sci Eng Ethics       Date:  2015-09-15       Impact factor: 3.525

2.  Modulating Macrophage Polarization through CCR2 Inhibition and Multivalent Engagement.

Authors:  Michael B Deci; Scott W Ferguson; Sydney L Scatigno; Juliane Nguyen
Journal:  Mol Pharm       Date:  2018-06-04       Impact factor: 4.939

Review 3.  Diverse Applications of Nanomedicine.

Authors:  Beatriz Pelaz; Christoph Alexiou; Ramon A Alvarez-Puebla; Frauke Alves; Anne M Andrews; Sumaira Ashraf; Lajos P Balogh; Laura Ballerini; Alessandra Bestetti; Cornelia Brendel; Susanna Bosi; Monica Carril; Warren C W Chan; Chunying Chen; Xiaodong Chen; Xiaoyuan Chen; Zhen Cheng; Daxiang Cui; Jianzhong Du; Christian Dullin; Alberto Escudero; Neus Feliu; Mingyuan Gao; Michael George; Yury Gogotsi; Arnold Grünweller; Zhongwei Gu; Naomi J Halas; Norbert Hampp; Roland K Hartmann; Mark C Hersam; Patrick Hunziker; Ji Jian; Xingyu Jiang; Philipp Jungebluth; Pranav Kadhiresan; Kazunori Kataoka; Ali Khademhosseini; Jindřich Kopeček; Nicholas A Kotov; Harald F Krug; Dong Soo Lee; Claus-Michael Lehr; Kam W Leong; Xing-Jie Liang; Mei Ling Lim; Luis M Liz-Marzán; Xiaowei Ma; Paolo Macchiarini; Huan Meng; Helmuth Möhwald; Paul Mulvaney; Andre E Nel; Shuming Nie; Peter Nordlander; Teruo Okano; Jose Oliveira; Tai Hyun Park; Reginald M Penner; Maurizio Prato; Victor Puntes; Vincent M Rotello; Amila Samarakoon; Raymond E Schaak; Youqing Shen; Sebastian Sjöqvist; Andre G Skirtach; Mahmoud G Soliman; Molly M Stevens; Hsing-Wen Sung; Ben Zhong Tang; Rainer Tietze; Buddhisha N Udugama; J Scott VanEpps; Tanja Weil; Paul S Weiss; Itamar Willner; Yuzhou Wu; Lily Yang; Zhao Yue; Qian Zhang; Qiang Zhang; Xian-En Zhang; Yuliang Zhao; Xin Zhou; Wolfgang J Parak
Journal:  ACS Nano       Date:  2017-03-14       Impact factor: 15.881

4.  Polyelectrolyte coating on superparamagnetic iron oxide nanoparticles as interface between magnetic core and biorelevant media.

Authors:  Etelka Tombácz; Katalin Farkas; Imre Földesi; Márta Szekeres; Erzsébet Illés; Ildikó Y Tóth; Daniel Nesztor; Tamás Szabó
Journal:  Interface Focus       Date:  2016-12-06       Impact factor: 3.906

Review 5.  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

Review 6.  Theranostic small interfering RNA nanoparticles in cancer precision nanomedicine.

Authors:  Zhihang Chen; Balaji Krishnamachary; Jesus Pachecho-Torres; Marie-France Penet; Zaver M Bhujwalla
Journal:  Wiley Interdiscip Rev Nanomed Nanobiotechnol       Date:  2019-10-23

Review 7.  Nanoparticles in Daily Life: Applications, Toxicity and Regulations.

Authors:  Ritu Gupta; Huan Xie
Journal:  J Environ Pathol Toxicol Oncol       Date:  2018       Impact factor: 3.567

Review 8.  Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities.

Authors:  Fatemeh Farjadian; Amir Ghasemi; Omid Gohari; Amir Roointan; Mahdi Karimi; Michael R Hamblin
Journal:  Nanomedicine (Lond)       Date:  2018-11-19       Impact factor: 5.307

Review 9.  Safety Considerations of Cancer Nanomedicine-A Key Step toward Translation.

Authors:  Xiangsheng Liu; Ivanna Tang; Zev A Wainberg; Huan Meng
Journal:  Small       Date:  2020-05-14       Impact factor: 13.281

Review 10.  Crossing the barrier: treatment of brain tumors using nanochain particles.

Authors:  Efstathios Karathanasis; Ketan B Ghaghada
Journal:  Wiley Interdiscip Rev Nanomed Nanobiotechnol       Date:  2016-01-09
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