Key considerations in the preclinical development of biosimilars

Drug Discovery Today

Volumn 20, Issue S1, 2015, Pages 3-15

  Bui, Lynne A ^a   Hurst, Susan ^b   Finch, Gregory L ^b   Ingram, Beverly ^b   Jacobs, Ira A ^b   Kirchhoff, Carol F ^b   Ng, Chee Keng ^b   Ryan, Anne M ^b  

^a Global Cancer Research Institute Inc (GCRI) for Personalized Oncology   (United States)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; MONOCLONAL ANTIBODY;

AMINO ACID SEQUENCE; ARTICLE; BIOLOGICAL ACTIVITY; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; FUNCTIONAL ASSESSMENT; GENE EXPRESSION SYSTEM; GLYCOSYLATION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PROTEIN EXPRESSION; PROTEIN PROCESSING; QUALITY CONTROL; SCALE UP; ANIMAL; CHEMICAL STRUCTURE; PROCEDURES; PRODUCT SAFETY; RISK FACTOR; STANDARDS; STRUCTURE ACTIVITY RELATION; THERAPEUTIC EQUIVALENCE;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; CONSUMER PRODUCT SAFETY; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; HUMANS; MOLECULAR STRUCTURE; QUALITY CONTROL; RISK FACTORS; STRUCTURE-ACTIVITY RELATIONSHIP; THERAPEUTIC EQUIVALENCY;

EID: 84930757289     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2015.03.011     Document Type: Review

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