A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A

Clinical Pharmacokinetics

Volumn 57, Issue 9, 2018, Pages 1123-1134

  Yoneyama, Koichiro ^a   Schmitt, Christophe ^b   Kotani, Naoki ^a   Levy, Gallia G ^c   Kasai, Ryu ^a   Iida, Satofumi ^a   Shima, Midori ^d   Kawanishi, Takehiko ^a  

^a CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c GENENTECH INC   (United States)

^d NARA MEDICAL UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

EMICIZUMAB; BISPECIFIC ANTIBODY; BLOOD CLOTTING FACTOR 8; MONOCLONAL ANTIBODY;

ABSORPTION HALF-LIFE; ADULT; ARTICLE; BLEEDING; CAUCASIAN; CLINICAL ARTICLE; DRUG CLEARANCE; DRUG EFFICACY; FEMALE; HEMOPHILIA A; HUMAN; JAPANESE (PEOPLE); LOADING DRUG DOSE; LOW DRUG DOSE; MAINTENANCE DRUG DOSE; MALE; PEAK-TROUGH FLUCTUATION; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RARE DISEASE; SIMULATION; SINGLE DRUG DOSE; STEADY STATE; TREATMENT DURATION; VOLUME OF DISTRIBUTION; ADOLESCENT; BIOLOGICAL MODEL; CLINICAL TRIAL; DOSE RESPONSE; IMMUNOLOGY; PHASE 3 CLINICAL TRIAL; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, BISPECIFIC; ANTIBODIES, MONOCLONAL, HUMANIZED; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR VIII; HEMOPHILIA A; HEMORRHAGE; HUMANS; MALE; MODELS, BIOLOGICAL; RARE DISEASES; YOUNG ADULT;

EID: 85037136993     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-017-0616-3     Document Type: Article

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