Quality, safety and efficacy of follow-on biologics in Japan

Biologicals

Volumn 39, Issue 5, 2011, Pages 328-332

  Yamaguchi, Teruhide ^a   Arato, Teruyo ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Biosimilar; Biotechnology; Follow on biologics

Indexed keywords

BIOLOGICAL PRODUCT; RECOMBINANT PROTEIN; SYNTHETIC PEPTIDE;

ARTICLE; CANADA; DRUG APPROVAL; DRUG EFFICACY; DRUG IMPURITY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG STABILITY; EUROPEAN UNION; JAPAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; WORLD HEALTH ORGANIZATION;

DRUG APPROVAL; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; JAPAN; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY CONTROL;

EID: 80053566882     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.015     Document Type: Article

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