Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines

Nanomedicine

Volumn 8, Issue 5, 2013, Pages 849-856

  Ehmann, Falk ^a   Sakai Kato, Kumiko ^b   Duncan, Ruth ^a   Pérez De La Ossa, Dolores Hernán ^a   Pita, Ruben ^a   Vidal, Jean Marc ^a   Kohli, Ashish ^c   Tothfalusi, Laszlo ^a   Sanh, Alan ^d   Tinton, Sandrine ^a   Robert, Jean Louis ^a   Silva Lima, Beatriz ^e   Amati, Marisa Papaluca ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b Japan Ministry of Health Labour and Welfare   (Japan)

^c MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^d Agence Nationale de Sécurité du Médicament and des Produits de Santé   (France)

^e UNIVERSITY OF LISBON   (Portugal)

Author keywords

block copolymer micelle; coating; colloidal iron based nanomedicine; drug development; liposomal formulation; nanomedicine; nanosimilar; next generation nanomedicine; regulatory science

Indexed keywords

COPOLYMER; LIPOSOME; NANOPARTICLE; NANOSIMILAR AGENT; UNCLASSIFIED DRUG;

ARTICLE; BIOEQUIVALENCE; COLLOID; DRUG BLOOD LEVEL; DRUG COATING; DRUG DESIGN; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG SAFETY; ENVIRONMENTAL IMPACT; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; JAPAN; MICELLE; NANOMEDICINE; PRIORITY JOURNAL;

EID: 84877656111     PISSN: 17435889     EISSN: 17486963     Source Type: Journal    
DOI: 10.2217/nnm.13.68     Document Type: Article

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