Considerations in the early development of biosimilar products

Drug Discovery Today

Volumn 20, Issue S2, 2015, Pages 1-9

  Li, Edward C ^a   Abbas, Richat ^b   Jacobs, Ira A ^b   Yin, Donghua ^b  

^a UNIVERSITY OF NEW ENGLAND   (United States)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; CLINICAL ASSESSMENT; CLINICAL EVALUATION; DRUG EFFICACY; DRUG SAFETY; EUROPEAN MEDICINES AGENCY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOGENICITY; NONHUMAN; PHARMACODYNAMICS; PRACTICE GUIDELINE; UNITED STATES; ANIMAL; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; EUROPE; LEGISLATION AND JURISPRUDENCE; PRECLINICAL STUDY; PROCEDURES; PRODUCT SAFETY; QUALITY CONTROL; RISK ASSESSMENT; STANDARDS; WORLD HEALTH ORGANIZATION;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; DRUG APPROVAL; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; EUROPE; GUIDELINES AS TOPIC; HUMANS; QUALITY CONTROL; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

EID: 84930818741     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2014.12.017     Document Type: Review

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