Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: Workshop summary report

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 24, Issue 3, 2011, Pages 119-135

  O'Connor, Dennis ^a   Adams, Wallace P ^b   Chen, Mei Ling ^b   Daley Yates, Peter ^c   Davis, John ^d   Derendorf, Hartmut ^e   Ducharme, Murray P ^f   Fuglsang, Anders ^g   Herrle, Myra ^h   Hochhaus, Günther ^e   Holmes, Susan M ⁱ   Lee, Sau L ^b   Li, Bing V ^b   Lyapustina, Svetlana ^j   Newman, Stephen ^k   Oliver, Martin ^l   Patterson, Beverley ^m   Peart, Joanne ⁿ   Poochikian, Guirag ^o   Roy, Partha ^b   Shah, Tushar ^p   Singh, Gur Jai Pal ^q   Sharp, Sandra Suarez ^b   more..

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^e UNIVERSITY OF FLORIDA   (United States)

^f Cetero Research   (United States)

^g Scientific Consultant   (Germany)

^h NOVARTIS PHARMA AG   (Switzerland)

ⁱ GLAXOSMITHKLINE   (United States)

^j Drinker Biddle and Reath   (United States)

^k Scientific Consultant   (United Kingdom)

^l VECTURA GROUP PLC   (United Kingdom)

^m Horsham Research Centre   (United Kingdom)

ⁿ VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^o Poochikian Pharma Consulting   (United States)

^p TEVA PHARMACEUTICALS   (Israel)

^q Axar Pharmaceuticals   (United States)

more..

Author keywords

bioequivalence; central peripheral ratio; pharmacokinetics; pulmonary deposition; systemic absorption

Indexed keywords

BRONCHODILATING AGENT; BUDESONIDE PLUS FORMOTEROL; CORTICOSTEROID; FLUTICASONE PROPIONATE PLUS SALMETEROL; FORMOTEROL FUMARATE; GLUCOSE; NITRIC OXIDE; PENTETATE TECHNETIUM TC 99M; POTASSIUM; SALBUTAMOL;

AEROSOL; AREA UNDER THE CURVE; ASTHMA; BIOAVAILABILITY; BIOEQUIVALENCE; BRONCHODILATATION; CONFERENCE PAPER; DRUG ABSORPTION; DRUG ACTIVITY; DRUG DELIVERY SYSTEM; DRUG EFFECT; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG TOXICITY; ELECTROCARDIOGRAM; FLOW RATE; FOOD AND DRUG ADMINISTRATION; FORCED EXPIRATORY VOLUME; GAMMA SCINTIGRAPHY; GLUCOSE BLOOD LEVEL; HUMAN; IN VITRO STUDY; IN VIVO STUDY; ISOTOPE LABELING; METERED DOSE INHALER; MUCOCILIARY CLEARANCE; PARTICLE SIZE; PH; PHARMACODYNAMICS; PHARMACOKINETICS; PHYSICAL CHEMISTRY; POTASSIUM BLOOD LEVEL; POWDER INHALER; QUALITY CONTROL; RESPIRATORY AIRFLOW; RESPIRATORY SYSTEM; SINGLE DRUG DOSE; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; SYSTEMIC CIRCULATION; TREMOR;

ADMINISTRATION, INHALATION; ADMINISTRATION, ORAL; ALBUTEROL; ANDROSTADIENES; DRUG AND NARCOTIC CONTROL; DRUG COMBINATIONS; ETHANOLAMINES; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 79958240542     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2011.0878     Document Type: Conference Paper

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