Biosimilars approval process

Regulatory Toxicology and Pharmacology

Volumn 56, Issue 3, 2010, Pages 374-377

  Zuñiga, Leyre ^a   Calvo, Begoña ^a  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

Author keywords

Application dossier; Biosimilars; Common Technical Document; Comparability; European guidelines; Regulatory

Indexed keywords

GENERIC DRUG; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ARTICLE; CLINICAL RESEARCH; COMPARABLE WORTH; DRUG APPROVAL; DRUG DOSE; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; HUMAN; IMMUNOGENICITY; IN VIVO STUDY; NEUTROPENIA; PHARMACODYNAMICS; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; TOXICITY TESTING; TREATMENT INDICATION;

BIOLOGICAL PRODUCTS; CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; EUROPEAN UNION; GOVERNMENT REGULATION; LEGISLATION, DRUG; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 77249086523     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.11.004     Document Type: Article

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