Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: Workshop summary report

AAPS Journal

Volumn 12, Issue 3, 2010, Pages 371-377

  Chen, Mei Ling ^a   Shah, Vinod P ^b   Ganes, Derek ^c   Midha, Kamal K ^b,d   Caro, James ^e   Nambiar, Prabu ^f   Rocci Jr , Mario L ^o   Thombre, Avinash G ^h   Abrahamsson, Bertil ⁱ   Conner, Dale ^a   Davit, Barbara ^a   Fackler, Paul ^j   Farrell, Colm ^g   Gupta, Suneel ^k   Katz, Russell ^a   Mehta, Mehul ^a   Preskorn, Sheldon H ^l   Sanderink, Gerard ^m   Stavchansky, Salomon ⁿ   Temple, Robert ^a   Wang, Yaning ^a   Winkle, Helen ^a   Yu, Lawrence ^a   more..

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

^b International Pharmaceutical Federation FIP   (Netherlands)

^c Taro Pharmaceuticals   (United States)

^d UNIVERSITY OF SASKATCHEWAN   (Canada)

^e Sanofi Aventis   (United States)

^f VERTEX PHARMACEUTICALS   (United States)

^g ICON Development Solutions   (United States)

^h PFIZER INC   (United States)

ⁱ ASTRAZENECA R AND D   (Sweden)

^j TEVA PHARMACEUTICALS   (Israel)

^k Impax Pharmaceuticals   (United States)

^l UNIVERSITY OF KANSAS   (United States)

^m SANOFI   (France)

ⁿ UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^o ICON Development Solutions   (United States)

more..

Author keywords

bioequivalence; interchangeability; modified release; pharmaceutical equivalence; therapeutic equivalence

Indexed keywords

AMFEBUTAMONE; FLUOXETINE; METHYLPHENIDATE; PLACEBO; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; ZOLPIDEM TARTRATE; DRUG;

ATTENTION DEFICIT DISORDER; BIOEQUIVALENCE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONFERENCE PAPER; CONTROLLED DRUG RELEASE; CONTROLLED RELEASE FORMULATION; DEPRESSION; DOSE RESPONSE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG CONTROL; DRUG DOSAGE FORM; DRUG DOSAGE FORM COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; INSOMNIA; MULTIPLE DRUG DOSE; PHARMACODYNAMICS; PHARMACOGENETICS; QUALITY CONTROL; THERAPEUTIC EQUIVALENCE;

PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY;

EID: 77955929888     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-010-9201-5     Document Type: Conference Paper

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