Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop summary report

European Journal of Pharmaceutical Sciences

Volumn 44, Issue 4, 2011, Pages 506-513

  Chen, Mei Ling ^a   Shah, Vinod P ^b   Crommelin, Daan J ^c   Shargel, Leon ^d   Bashaw, Dennis ^a   Bhatti, Masood ^e   Blume, Henning ^b   Dressman, Jennifer ^f   Ducharme, Murray ^g   Fackler, Paul ^h   Hyslop, Terry ⁱ   Lutter, Lorelei ^e   Morais, Jose ^j   Ormsby, Eric ^k   Thomas, Saji ^l   Tsang, Yu Chung ^m   Velagapudi, Raja ⁿ   Yu, Lawrence X ^a  

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

^b International Pharmaceutical Federation ^*  (Germany)

^c UTRECHT UNIVERSITY   (Netherlands)

^d Applied Biopharmaceutics   (United States)

^e Bio Pharma Services Inc   (Canada)

^f GOETHE UNIVERSITY   (Germany)

^g Cetero Research   (United States)

^h MERCK RESEARCH LABORATORIES   (United States)

ⁱ THOMAS JEFFERSON UNIVERSITY   (United States)

^j UNIVERSITY OF LISBON   (Portugal)

^k HEALTH CANADA   (Canada)

^l Par Pharmaceutical   (United States)

^m Apotex Inc   (Canada)

ⁿ TEVA Pharmaceuticals   (United States)

more..

Author keywords

Bioequivalence; Biopharmaceutics classification system; Harmonization; Interchangeability; Regulatory standards; Therapeutic equivalence

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; DIGOXIN; GENERIC DRUG; LITHIUM; PHENYTOIN; THEOPHYLLINE; WARFARIN; ZOLPIDEM TARTRATE;

AREA UNDER THE CURVE; BIOEQUIVALENCE; COMPARATIVE STUDY; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL (TOPIC); DIET RESTRICTION; DRUG APPROVAL; DRUG CONTROL; DRUG EXPOSURE; DRUG INDUSTRY; DRUG MONITORING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; FOOD INTAKE; GOVERNMENT; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; PHARMACODYNAMICS; PHARMACOKINETICS; PRIORITY JOURNAL; SCIENTIST; STUDY DESIGN;

CANADA; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUGS, GENERIC; EUROPE; HUMANS; INTERNATIONALITY; THERAPEUTIC EQUIVALENCY; UNITED STATES; WORLD HEALTH ORGANIZATION;

EID: 80455143771     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2011.09.010     Document Type: Conference Paper

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