Pharmaceutical equivalence by design for generic drugs: Modified-release products

Pharmaceutical Research

Volumn 28, Issue 7, 2011, Pages 1445-1453

  Raw, André Sirota ^a   Lionberger, Robert ^a   Yu, Lawrence X ^a  

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

Author keywords

generic drugs; modified release; pharmaceutical equivalence; quality by design (QbD); quality target product profile (QTPP); therapeutic equivalence

Indexed keywords

GENERIC DRUG; HYDROMORPHONE; METHYLPHENIDATE; OMEPRAZOLE; PROTON PUMP INHIBITOR; ZOLPIDEM;

ANALYTIC METHOD; AREA UNDER THE CURVE; BIOEQUIVALENCE; DRUG ABSORPTION; DRUG COATING; DRUG DEGRADATION; DRUG DESIGN; DRUG FORMULATION; DRUG RELEASE; FOOD AND DRUG ADMINISTRATION; HYDRODYNAMICS; MAXIMUM PLASMA CONCENTRATION; PHARMACEUTICS; PHARMACODYNAMICS; PRIORITY JOURNAL; QUALITY BY DESIGN INITIATIVE; QUALITY CONTROL; QUALITY TARGET PRODUCT PROFILE; REFERENCE DATABASE; REVIEW; STOMACH PH;

DELAYED-ACTION PREPARATIONS; DRUGS, GENERIC; HUMANS; REFERENCE STANDARDS; THERAPEUTIC EQUIVALENCY; UNITED STATES;

EID: 79959891084     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0397-6     Document Type: Review

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