The therapeutic equivalence of complex drugs

Regulatory Toxicology and Pharmacology

Volumn 59, Issue 1, 2011, Pages 176-183

  Schellekens, Huub ^a   Klinger, Ety ^b   Mühlebach, Stefan ^c   Brin, Jean Francois ^d   Storm, Gert ^e,f   Crommelin, Daan J A ^e,f,g  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Global Innovative R and D   (Israel)

^c Vifor (International) Inc   (Switzerland)

^d SANOFI   (France)

^e UTRECHT UNIVERSITY   (Netherlands)

^f Dutch Top Institute Pharma ^*  (Netherlands)

^g LYGATURE   (Netherlands)

Author keywords

Bioequivalence; Biologics; Biosimilars; Glatiramoids; Immunogenicity; Iron carbohydrate complexes; Liposomes; LMWH; Therapeutic equivalence

Indexed keywords

DAUNORUBICIN; DOXORUBICIN; FERRIC HYDROXIDE SUCROSE; GENERIC DRUG; GLATIRAMER; HEPARIN; LIPOSOME; LOW MOLECULAR WEIGHT HEPARIN;

ANTIINFLAMMATORY ACTIVITY; ARTICLE; BIOEQUIVALENCE; DRUG ACTIVITY; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MECHANISM; DRUG SCREENING; DRUG STRUCTURE; EXPIRATION DATE; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IRON DEFICIENCY ANEMIA; MULTIPLE SCLEROSIS; NONHUMAN; OXIDATION REDUCTION REACTION; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; UNSPECIFIED SIDE EFFECT; VENOUS THROMBOEMBOLISM;

ANTICOAGULANTS; BIOLOGICAL PRODUCTS; CONGRESSES AS TOPIC; CONSUMER PRODUCT SAFETY; DRUGS, GENERIC; EVIDENCE-BASED MEDICINE; FERRIC COMPOUNDS; HEMATINICS; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LEGISLATION, DRUG; LIPOSOMES; PATENTS AS TOPIC; PEPTIDES; PROTEINS; RISK ASSESSMENT; SUCROSE; THERAPEUTIC EQUIVALENCY;

EID: 78751569565     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.09.021     Document Type: Article

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