Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties

Nijhara, Ruchika; Balakrishnan, K

doi:10.1016/j.nano.2006.04.005

Cited by 67 publications

(39 citation statements)

References 6 publications

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“…Another advantage is the facilitation of drug delivery across various barriers, the most important of which is the blood brain barrier (BBB). NPs currently used include liposomes (L), polymeric nanoparticles (PNP), polymeric micelles (PM), dendrimers, gold NPs, quantum dots, carbon nanotubes, and nanofibers [4][5][6][7][8].…”

Section: Targeted Drug Deliverymentioning

confidence: 99%

Antibody-Conjugated Nanoparticles for Therapeutic Applications

Cardoso

Peça²,

Roque³

2012

CMC

112

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Abstract:A great challenge to clinical development is the delivery of chemotherapeutic agents, known to cause severe toxic effects, directly to diseased sites which increase the therapeutic index whilst minimizing off-target side effects. Antibody-conjugated nanoparticles offer great opportunities to overcome these limitations in therapeutics. They combine the advantages given by the nanoparticles with the ability to bind to their target with high affinity and improve cell penetration given by the antibodies. This specialized vehicle, that can encapsulate several chemotherapeutic agents, can be engineered to possess the desirable properties, allowing overcoming the successive physiological conditions and to cross biological barriers and reach a specific tissue or cell. Moreover, antibody-conjugated nanoparticles have shown the ability to be internalized through receptor-mediated endocytosis and accumulate in cells without being recognized by the P-glycoprotein, one of the main mediators of multi-drug resistance, resulting in an increase in the intracellular concentration of drugs. Also, progress in antibody engineering has allowed the manipulation of the basic antibody structure for raising and tailoring specificity and functionality. This review explores recent developments on active drug targeting by nanoparticles functionalized with monoclonal antibodies (polymeric micelles, liposomes and polymeric nanoparticles) and summarizes the opportunities of these targeting strategies in the therapy of serious diseases (cancer, inflammatory diseases, infectious diseases, and thrombosis).

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Section: Targeted Drug Deliverymentioning

confidence: 99%

Antibody-Conjugated Nanoparticles for Therapeutic Applications

Cardoso

Peça²,

Roque³

2012

CMC

112

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“…The possibility of release of nanomaterials into the environment [16][17][18][19][20] results in the serious concerns about safety issues dealing with: 1) their higher toxicity in A c c e p t e d M a n u s c r i p t comparison with their bulk counterparts; 2) the absence of the legislation normative for permitted levels of various NMs in water and air; and 3) the absence of the adequate analytical techniques for detection of NMs in the environment [21,22].…”

Section: Introductionmentioning

confidence: 99%

Intermatrix Synthesis as a rapid, inexpensive and reproducible methodology for the in situ functionalization of nanostructured surfaces with quantum dots

Bastos-Arrieta

Muñoz

Stenbock-Fermor

et al. 2016

Applied Surface Science

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Multiwall Carbon Nanotubes (MWCNTs) and Nanodiamonds (NDs). The synthetic route takes advantage of the ion exchange functionality of the reactive surfaces for the loading of the QDs precursor and consequent QDs appearance by precipitation. The benefits of such modified nanomaterials were studied using CdS-QDs@MWCNTs hybrid-nanomaterials.CdS-QDs@MWCNTs has been used as conducting filler for the preparation of electrochemical nanocomposite sensors, which present electrocatalytic properties. Finally,

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“…Further, when a nanodrug is designed as a new chemical entity, the evaluation procedure becomes more stringent. 41 Nanodrug manufacturers must comply with FDA's Current Good Manufacturing Practices (CGMP) and Quality System Regulations (QSR). 42 The equipments for nanodrug manufacturing and control of contamination also come under stringent regulation.…”

Section: Regulatory Challenges With Nanomedicinesmentioning

confidence: 99%