How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: Points to consider

AAPS Journal

Volumn 16, Issue 1, 2014, Pages 15-21

  Schellekens, Huub ^a   Stegemann, Sven ^b   Weinstein, Vera ^c   De Vlieger, Jon S B ^d   Flühmann, Beat ^e   Mühlebach, Stefan ^e   Gaspar, Rogério ^f   Shah, Vinod P ^g   Crommelin, Daan J A ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b CAPSUGEL   (France)

^c TEVA PHARMACEUTICALS   (Israel)

^d LYGATURE   (Netherlands)

^e Vifor (International) Inc   (Switzerland)

^f RESEARCH INSTITUTE FOR MEDICINES IMED ULISBOA   (Portugal)

^g University of Lisbon ^*

Author keywords

Biosimilars; Generics; Nonbiological complex drugs; Regulatory guidance; Substitution

Indexed keywords

CARBOHYDRATE; COPOLYMER; DOXORUBICIN; DRUG; GLATIRAMER; GLATIRAMOID DERIVATIVE; IRON; LIPOSOME; NONBIOLOGICAL COMPLEX DRUG; UNCLASSIFIED DRUG;

CHEMICAL STRUCTURE; DRUG EFFICACY; DRUG FORMULATION; DRUG QUALITY; DRUG SAFETY; ENCAPSULATION; HUMAN; NONHUMAN; PARTICLE SIZE; PHYSICAL CHEMISTRY; REVIEW;

DRUG AND NARCOTIC CONTROL; DRUGS, GENERIC; LIPOSOMES; NANOPARTICLES; PROTEINS;

EID: 84893056272     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9533-z     Document Type: Review

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