Japanese Regulatory Perspective on Immunogenicity

Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations

Volumn , Issue , 2011, Pages 57-79

  Hayakawa, Takao ^a   Ishii Watabe, Akiko ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Current status in Japan immunogenicity assessment, clinical use of product; Japanese regulatory perspective no official guidelines, therapeutic protein product immunogenicity; Therapeutic protein product immunogenicity, factors as humoral immune responses

Indexed keywords

EID: 84886027323     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118075685.ch4     Document Type: Chapter

References (52)

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