Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9

AAPS Journal

Volumn 17, Issue 4, 2015, Pages 881-890

  Budha, Nageshwar R ^a   Leabman, Maya ^a   Jin, Jin Y ^a   Wada, D Russell ^b   Baruch, Amos ^a   Peng, Kun ^a   Tingley, Whittemore G ^a   Davis, John D ^a,c  

^a GENENTECH INC   (United States)

^b Quantitative Solutions   (United States)

^c REGENERON PHARMACEUTICALS INC   (United States)

Author keywords

antibody; LDLc; modeling and simulation; PCSK9; PK PD

Indexed keywords

LOW DENSITY LIPOPROTEIN CHOLESTEROL; MONOCLONAL ANTIBODY; PLACEBO; RG 7652; UNCLASSIFIED DRUG; PCSK9 PROTEIN, HUMAN; PROPROTEIN CONVERTASE 9; RG7652; SERINE PROTEINASE;

ADULT; ARTICLE; CASE STUDY; DOSE CALCULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; HUMAN; HUMAN EXPERIMENT; MATHEMATICAL MODEL; NORMAL HUMAN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PREDICTION; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SINGLE DRUG DOSE; VOLUME OF DISTRIBUTION; ANTAGONISTS AND INHIBITORS; BIOLOGICAL MODEL; BLOOD; CLINICAL TRIAL; COMPUTER SIMULATION; CONTROLLED STUDY; DOSE RESPONSE; FEMALE; HYPERCHOLESTEROLEMIA; MALE; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADULT; ANTIBODIES, MONOCLONAL; CHOLESTEROL, LDL; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; HYPERCHOLESTEROLEMIA; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PROPROTEIN CONVERTASE 9; PROPROTEIN CONVERTASES; SERINE ENDOPEPTIDASES; YOUNG ADULT;

EID: 84931577348     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9750-8     Document Type: Article

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