Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the us food and drug administration

AAPS Journal

Volumn 14, Issue 4, 2012, Pages 915-924

  Davit, Barbara M ^a   Chen, Mei Ling ^a   Conner, Dale P ^a   Haidar, Sam H ^a   Kim, Stephanie ^a   Lee, Christina H ^a   Lionberger, Robert A ^a   Makhlouf, Fairouz T ^a   Nwakama, Patrick E ^a   Patel, Devvrat T ^a   Schuirmann, Donald J ^a   Yu, Lawrence X ^a  

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

Author keywords

Bioequivalence; Generic drugs; Highly variable drugs; Reference scaled average bioequivalence; US Food and Drug Administration

Indexed keywords

GENERIC DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; REFERENCE SCALED AVERAGE BIOEQUIVALENCE; REVIEW; UNITED STATES;

DRUG APPROVAL; DRUGS, GENERIC; HUMANS; PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84869120005     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9406-x     Document Type: Review

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