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

Nanomedicine

Volumn 10, Issue 4, 2015, Pages 659-674

  Mühlebach, Stefan ^a,b   Borchard, Gerrit ^c   Yildiz, Selcan ^d  

^a Vifor (International) Inc   (Switzerland)

^b UNIVERSITY OF BASEL   (Switzerland)

^c UNIVERSITY OF GENEVA   (Switzerland)

^d UTRECHT UNIVERSITY   (Netherlands)

Author keywords

glatiramoids; liposomes; nanocolloidal iron carbohydrates; nanomedicines; nanosimilars; nonbiological complex drugs; stepwise regulatory approach for follow on versions

Indexed keywords

CARBOHYDRATE DERIVATIVE; COPOLYMER; GLATIRAMOID DERIVATIVE; IRON DERIVATIVE; LIPOSOME; NANOPARTICLE; UNCLASSIFIED DRUG;

COLLOID; DRUG MANUFACTURE; DRUG MARKETING; HUMAN; NANOMEDICINE; NANOSIMILAR; NONHUMAN; PATIENT SAFETY; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; CHEMISTRY; DRUG CONTROL; LEGISLATION AND JURISPRUDENCE; NANOTECHNOLOGY; ORGANIZATION AND MANAGEMENT; PROCEDURES; STANDARDS;

DRUG AND NARCOTIC CONTROL; HUMANS; NANOMEDICINE; NANOPARTICLES; NANOTECHNOLOGY;

EID: 84924187503     PISSN: 17435889     EISSN: 17486963     Source Type: Journal    
DOI: 10.2217/nnm.14.189     Document Type: Review

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