Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 μg and fluticasone propionate 250 μg: Implications for establishing bioequivalence of inhaled products

Clinical Therapeutics

Volumn 31, Issue 2, 2009, Pages 370-385

  Daley Yates, Peter T ^a   Parkins, David A ^a   Thomas, Marian J ^a   Gillett, Benjamin ^a   House, Karen W ^b   Ortega, Hector G ^b  

^a GLAXOSMITHKLINE   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

Author keywords

bioequivalence; clinical trial; dry powder inhaler; fluticasone propionate; in vitro; salmeterol

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BECLOMETASONE DIPROPIONATE; BILIRUBIN; BUDESONIDE; CREATININE; FLUNISOLIDE; FLUTICASONE PROPIONATE PLUS SALMETEROL; GAMMA GLUTAMYLTRANSFERASE; GLUCOSE; HEMOGLOBIN; HYDROCORTISONE; POTASSIUM;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHMA; BILIRUBIN BLOOD LEVEL; BIOEQUIVALENCE; BLOOD CELL COUNT; BLOOD SAMPLING; BRONCHITIS; CELL VOLUME; CHEMOLUMINESCENCE; CHILD; CLINICAL STUDY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DISEASE CONTROL; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG SAFETY; DRUG URINE LEVEL; DYSPHAGIA; DYSPHONIA; FEMALE; FLOW RATE; FORCED EXPIRATORY VOLUME; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GLUCOSE BLOOD LEVEL; HEART RATE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYDROCORTISONE URINE LEVEL; IN VITRO STUDY; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MODERATE PERSISTENT ASTHMA; MUCOSA INFLAMMATION; PARTICLE SIZE; PEAK EXPIRATORY FLOW; POTASSIUM BLOOD LEVEL; POWDER INHALER; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; TREMOR; VITAL SIGN;

ADOLESCENT; ADULT; AGED; ALBUTEROL; ANDROSTADIENES; AREA UNDER CURVE; ASTHMA; BRONCHODILATOR AGENTS; CHILD; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEBULIZERS AND VAPORIZERS; PARTICLE SIZE; PEAK EXPIRATORY FLOW RATE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 62149094354     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.02.007     Document Type: Article

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