Recommendations regarding technical standards for follow-on biologics: Comparability, similarity, interchangeability

Current Medical Research and Opinion

Volumn 25, Issue 7, 2009, Pages 1655-1661

  Davis, Gregory C ^a   Beals, John M ^a   Johnson, Craig ^a   Mayer, Mark H ^a   Meiklejohn, Bruce I ^a   Mitlak, Bruce H ^a   Roth, Jody L ^a   Towns, John K ^a   Veenhuizen, Melissa ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

CLINICAL EVALUATION; DRUG APPROVAL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; NOTE; PATIENT SAFETY;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUG EVALUATION; HEALTH PLANNING GUIDELINES; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; PRODUCT SURVEILLANCE, POSTMARKETING; THERAPEUTIC EQUIVALENCY;

EID: 67650480209     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007990903017313     Document Type: Note

References (18)

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