Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European workshop report

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 25, Issue 3, 2012, Pages 117-139

  Evans, Carole ^a   Cipolla, David ^b   Chesworth, Tim ^c   Agurell, Eva ^d   Ahrens, Richard ^e   Conner, Dale ^f   Dissanayake, Sanjeeva ^g   Dolovich, Myrna ^h   Doub, William ^f   Fuglsang, Anders ⁱ   Arieta, Afredo García ^j   Golden, Michael ^c   Hermann, Robert ^k   Hochhaus, Günther ^l   Holmes, Susan ^m   Lafferty, Paul ⁿ   Lyapustina, Svetlana ^o   Nair, Parameswaran ^h   O'Connor, Dennis ^p   Parkins, David ^q   Peterson, Ilse ^o   Reisner, Colin ^c   Sandell, Dennis ^r   Singh, Gur Jai Pal ^s   Weda, Marjolein ^t   Watson, Patricia ^q   more..

^a CATALENT PHARMA SOLUTIONS   (United States)

^b Aradigm   (United States)

^c ASTRAZENECA   (United Kingdom)

^d MEDICAL PRODUCTS AGENCY   (Sweden)

^e UNIVERSITY OF IOWA   (United States)

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

^g Mundipharma Research   (United Kingdom)

^h MCMASTER UNIVERSITY   (Canada)

ⁱ Fuglsang Pharma   (Germany)

^j Department of Human Use Medicines   (Spain)

^k Clinical Research Appliance Crappliance   (Germany)

^l UNIVERSITY OF FLORIDA   (United States)

^m GLAXOSMITHKLINE   (United States)

ⁿ Medical Technology Consulting   (United Kingdom)

^o Drinker Biddle and Reath   (United States)

^p BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^q GLAXOSMITHKLINE   (United Kingdom)

^r S5 Consulting   (Sweden)

^s Axar Pharmaceuticals   (United States)

^t NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

more..

Author keywords

device; equivalence; goalposts; in vitro; inhaler; IVIVC; patient handling; pharmacodynamics; pharmacokinetics

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CHARCOAL; CORTICOSTEROID; FLUTICASONE PROPIONATE; MUSCARINIC RECEPTOR BLOCKING AGENT; SALMETEROL;

AREA UNDER THE CURVE; ARTICLE; ASTHMA; BIOASSAY; BIOEQUIVALENCE; CANADA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL PRACTICE; CLINICAL STUDY; CORRELATION ANALYSIS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG INDUSTRY; DRUG SAFETY; EUROPE; EUROPEAN UNION; HUMAN; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; IN VITRO STUDY; INHALATIONAL DRUG ADMINISTRATION; LUNG FUNCTION; MAXIMUM PLASMA CONCENTRATION; MEDICAL DEVICE; MEDICAL SOCIETY; METERED DOSE INHALER; NEBULIZATION; ORAL DRUG ADMINISTRATION; PARTICLE SIZE; POWDER INHALER; PRACTICE GUIDELINE; RISK MANAGEMENT; TIME TO MAXIMUM PLASMA CONCENTRATION; TOTAL QUALITY MANAGEMENT; UNITED STATES; WORKSHOP; XEROSTOMIA;

ADMINISTRATION, INHALATION; AEROSOLS; BIOLOGICAL AVAILABILITY; CANADA; DRUG AND NARCOTIC CONTROL; DRY POWDER INHALERS; EUROPE; HUMANS; LUNG; METERED DOSE INHALERS; MODELS, THEORETICAL; PARTICLE SIZE; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862283162     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2011.0968     Document Type: Article

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98. See www.iso.org, www.ich.org and www.ghtf.org for more information on these bodies.
99. See www.fda.gov for more information on the FDA, CDER, and CDRH.