The similarity question for biologicals and non-biological complex drugs

European Journal of Pharmaceutical Sciences

Volumn 76, Issue , 2015, Pages 10-17

  Crommelin, Daan J A ^a   Shah, Vinod P ^b   Klebovich, Imre ^c   McNeil, Scott E ^d   Weinstein, Vera ^e   Flühmann, Beat ^f   Mühlebach, Stefan ^f,g   De Vlieger, Jon S B ^h  

^a UTRECHT UNIVERSITY   (Netherlands)

^b North Potomac ^*  (United States)

^c SEMMELWEIS UNIVERSITY   (Hungary)

^d FREDERICK NATIONAL LABORATORY FOR CANCER RESEARCH   (United States)

^e TEVA PHARMACEUTICALS   (Israel)

^f Vifor (International) Inc   (Switzerland)

^g UNIVERSITY OF BASEL   (Switzerland)

^h Dutch Top Institute Pharma   (Netherlands)

Author keywords

Biologicals; Biosimilars; Glatiramoids; Iron carbohydrate complexes; Liposomes; Nanomedicines; Non biological complex drugs

Indexed keywords

BIOSIMILAR AGENT; CARBOHYDRATE; GLATIRAMOID; IRON; LIPOSOME; NON BIOLOGICAL COMPLEX DRUG; UNCLASSIFIED DRUG; BIOLOGICAL PRODUCT; DRUG; GENERIC DRUG;

ARTICLE; BIOEQUIVALENCE; DRUG INFORMATION; DRUG LEGISLATION; MOLECULAR WEIGHT; NONHUMAN; PHARMACEUTICAL EQUIVALENCE; PRIORITY JOURNAL; ANIMAL; CHEMICAL STRUCTURE; CHEMISTRY; CLASSIFICATION; DRUG APPROVAL; HUMAN; NOMENCLATURE; PATIENT SAFETY; PRACTICE GUIDELINE; RISK ASSESSMENT; STRUCTURE ACTIVITY RELATION; THERAPEUTIC EQUIVALENCE;

ANIMALS; BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUGS, GENERIC; GUIDELINES AS TOPIC; HUMANS; MOLECULAR STRUCTURE; PATIENT SAFETY; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; STRUCTURE-ACTIVITY RELATIONSHIP; TERMINOLOGY AS TOPIC; THERAPEUTIC EQUIVALENCY;

EID: 84929094956     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2015.04.010     Document Type: Note

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