Assessing monoclonal antibody product quality attribute criticality through clinical studies

mAbs

Volumn 2, Issue 5, 2010, Pages 500-507

  Goetze, Andrew M ^a   Schenauer, Matthew R ^a   Flynn, Gregory C ^a  

^a AMGEN INC   (United States)

Author keywords

Biotransformations; Critical quality attributes; Microheterogeneity; Pharmacokinetics; Quality by design

Indexed keywords

MONOCLONAL ANTIBODY;

ANTIBODY PRODUCTION; AREA UNDER THE CURVE; CLINICAL STUDY; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; HUMAN; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; REVIEW;

ANIMALS; ANTIBODIES, MONOCLONAL; AREA UNDER CURVE; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; HUMANS; TREATMENT OUTCOME;

EID: 77958584087     PISSN: 19420862     EISSN: None     Source Type: Journal    
DOI: 10.4161/mabs.2.5.12897     Document Type: Review

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