Summary workshop report: Bioequivalence, biopharmaceutics classification system, and beyond

AAPS Journal

Volumn 10, Issue 2, 2008, Pages 373-379

  Polli, James E ^a   Abrahamsson, Bertil S I ^b   Yu, Lawrence X ^c   Amidon, Gordon L ^d   Baldoni, John M ^e   Cook, Jack A ^f   Fackler, Paul ^g   Hartauer, Kerry ^h   Johnston, Gordon ⁱ   Krill, Steve L ^j   Lipper, Robert A ^k   Malick, Waseem A ^l   Shah, Vinod P ^m   Sun, Duxin ⁿ   Winkle, Helen N ^c   Wu, Yunhui ^o   Zhang, Hua ^p  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^b ASTRAZENECA R AND D   (Sweden)

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

^d UNIVERSITY OF MICHIGAN   (United States)

^e GLAXOSMITHKLINE   (United States)

^f PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^g TEVA PHARMACEUTICALS   (Israel)

^h ELI LILLY AND COMPANY   (United States)

ⁱ Generic Pharmaceutical Association   (United States)

^j BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^k BRISTOL MYERS SQUIBB   (United States)

^l HOFFMANN LA ROCHE INC   (United States)

^m North Potomac   (United States)

ⁿ OHIO STATE UNIVERSITY   (United States)

^o MERCK RESEARCH LABORATORIES   (United States)

^p ASTRAZENECA   (United Kingdom)

more..

Author keywords

Bioavailability; Bioequivalence; Biopharmaceutics classification system (BCS); Oral absorption; Permeability; Regulatory science; Solubility

Indexed keywords

DRUG;

BIOEQUIVALENCE; CONFERENCE PAPER; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG FORMULATION; DRUG LEGISLATION; DRUG PENETRATION; DRUG RESEARCH; DRUG SOLUBILITY; DRUG UTILIZATION; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; PREDICTION; WORKSHOP;

BIOPHARMACEUTICS; CONGRESSES AS TOPIC; DRUG DESIGN; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 53849133765     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-008-9040-9     Document Type: Conference Paper

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