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Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars

Mühlebach, Stefan and Borchard, Gerrit and Yildiz, Selcan. (2015) Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars. Nanomedicine (London, England), 10 (4). pp. 659-674.

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Official URL: https://edoc.unibas.ch/72679/

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Abstract

Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Klinische Pharmazie/Spitalpharmazie (Meier)
UniBasel Contributors:Mühlebach, Stefan F
Item Type:Article, refereed
Article Subtype:Research Article
ISSN:1748-6963
e-ISSN:1549-9634
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:23 May 2020 16:29
Deposited On:23 May 2020 16:29

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