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

Clinical Therapeutics

Volumn 32, Issue 10, 2010, Pages 1704-1712

  Chen, Mei Ling ^a   Shah, Vinod P ^b   Ganes, Derek ^c   Midha, Kamal K ^b,d   Caro, James ^e   Nambiar, Prabu ^f   Rocci, Mario L ^g   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   (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 Pfzer Inc   (United States)

ⁱ ASTRAZENECA R AND D   (Sweden)

^j TEVA PHARMACEUTICALS   (Israel)

^k Impax Laboratories Inc   (United States)

^l UNIVERSITY OF KANSAS   (United States)

^m SANOFI   (France)

ⁿ UNIVERSITY OF TEXAS AT AUSTIN   (United States)

more..

Author keywords

Bioequivalence; Interchangeability; Modified release; Pharmaceutical equivalence; Therapeutic equivalence

Indexed keywords

ARTICLE; BIOEQUIVALENCE; CONTROLLED RELEASE FORMULATION; DOSE RESPONSE; DRUG ABSORPTION; DRUG APPROVAL; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG INDUSTRY; DRUG PENETRATION; DRUG SAFETY; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; MAXIMUM PLASMA CONCENTRATION; MEDICAL SOCIETY; TIME TO MAXIMUM PLASMA CONCENTRATION; WORKSHOP;

EID: 78650587953     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.09.014     Document Type: Article

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