Effects of particle size, food, and capsule shell composition on the oral bioavailability of dabrafenib, a BRAF inhibitor, in patients with BRAF mutation-positive tumors

Journal of Pharmaceutical Sciences

Volumn 102, Issue 9, 2013, Pages 3100-3109

  Ouellet, Daniele ^a   Grossmann, Kenneth F ^b   Limentani, Giselle ^a   Nebot, Noelia ^a   Lan, Kevin ^a   Knowles, Lara ^a   Gordon, Michael S ^c   Sharma, Sunil ^b   Infante, Jeffrey R ^d   Lorusso, Patricia M ^e   Pande, Girish ^a   Krachey, Elizabeth C ^a   Blackman, Samuel C ^a,f   Carson, Stanley W ^a  

^a GLAXOSMITHKLINE   (United States)

^b UNIVERSITY OF UTAH   (United States)

^c Pinnacle Oncology Hematology   (United States)

^d SARAH CANNON RESEARCH INSTITUTE   (United States)

^e KARMANOS CANCER INSTITUTE   (United States)

^f SEATTLE GENETICS INC   (United States)

Author keywords

Bioavailability; Capsules; Clinical pharmacokinetics; Dabrafenib; Dissolution; Food effects; Gelatin; HPMC; Particle size; Supersaturation

Indexed keywords

B RAF KINASE; DABRAFENIB; GELATIN; HYDROXYPROPYLMETHYLCELLULOSE;

ABDOMINAL PAIN; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CHEMOTHERAPY INDUCED ANEMIA; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FEVER; DRUG HALF LIFE; DRUG SAFETY; DRUG SOLUBILITY; DRUG TOLERABILITY; FEMALE; FOOD COMPOSITION; HUMAN; IN VITRO STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MELANOMA; OPEN STUDY; PARTICLE SIZE; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SIMULATION; SINGLE DRUG DOSE; STOMACH JUICE;

BIOAVAILABILITY; CAPSULES; CLINICAL PHARMACOKINETICS; DABRAFENIB; DISSOLUTION; FOOD EFFECTS; GELATIN; HPMC; PARTICLE SIZE; SUPERSATURATION;

ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC AGENTS; BIOLOGICAL AVAILABILITY; CAPSULES; COHORT STUDIES; FASTING; FEMALE; HUMANS; IMIDAZOLES; MALE; MELANOMA; METHYLCELLULOSE; MIDDLE AGED; OXIMES; PARTICLE SIZE; POINT MUTATION; PROTO-ONCOGENE PROTEINS B-RAF;

EID: 84881611323     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23519     Document Type: Article

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