Regulatory Guidelines of the US Food and Drug Administration and the European Medicines Agency for Actively Targeted Nanomedicines

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dc.authorscopusid57210356867
dc.authorscopusid57212018375
dc.authorscopusid57193089016
dc.authorscopusid6603768177
dc.contributor.authorÇetintaş H.C.
dc.contributor.authorTonbul H.
dc.contributor.authorŞahin A.
dc.contributor.authorÇapan Y.
dc.date.accessioned2024-08-04T20:04:02Z
dc.date.available2024-08-04T20:04:02Z
dc.date.issued2021
dc.departmentİnönü Üniversitesien_US
dc.description.abstractGuidelines for nanomedicines that are published by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are listed later. This chapter reviews the current FDA and EMA regulatory guidelines for nanomedicines and evaluate their potential for use as reference for actively targeted nanomedicines. The FDA has recommended determining critical quality attributes that have a potential impact on product performance and utilize risk assessments that link structure–function relationships. The FDA recommends considering some points for selecting and using characterization methods. The FDA obligates to manufacture nanomaterials containing drugs in accordance with Good Manufacturing Practices similar to all drug products. The FDA states that all existing International Conference on Harmonization guidelines addressing nonclinical studies be generally applicable for nanomaterials containing drugs. The FDA states that the drug release characteristics of liposomes should be analyzed and release differences between liposomal and nonliposomal formulations should be added to the application. © 2022 Jenny Stanford Publishing Pte. Ltd.en_US
dc.identifier.doi10.1201/9781003164739-27
dc.identifier.endpage741en_US
dc.identifier.isbn9781000375268
dc.identifier.isbn9789814877756
dc.identifier.scopus2-s2.0-85128112362en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage725en_US
dc.identifier.urihttps://doi.org/10.1201/9781003164739-27
dc.identifier.urihttps://hdl.handle.net/11616/92314
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherTaylor and Francisen_US
dc.relation.ispartofDrug Delivery with Targeted Nanoparticles: In Vitro and in Vivo Evaluation Methodsen_US
dc.relation.publicationcategoryKitap Bölümü - Uluslararasıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subject[No Keyword]en_US
dc.titleRegulatory Guidelines of the US Food and Drug Administration and the European Medicines Agency for Actively Targeted Nanomedicinesen_US
dc.typeBook Chapteren_US

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