caa a22 4500 445312319 CHVBK 20180317142634.0 cr unu---uuuuu 170323e20110701xx s 000 0 eng 10.1007/s11095-011-0397-6 doi (NATIONALLICENCE)springer-10.1007/s11095-011-0397-6 Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products [Elektronische Daten] [André Raw, Robert Lionberger, Lawrence Yu] ABSTRACT: The Office of Generic Drugs has ensured the high quality of generic products based upon two requirements: pharmaceutical equivalence and bioequivalence to the reference listed drug (RLD). This paradigm has been used with success toward ensuring quality generic drug products that provide the same therapeutic benefit as the RLD. Drug products have increased in design complexity; as a result, approaches to ensure therapeutic equivalence must evolve to provide assurance of quality generic drug products. The Food and Drug Administration quality by design initiative (QbD) provides an enhanced evaluation approach by introducing the concept of a quality target product profile (QTPP). The QTPP introduces, within the context of the current regulatory framework, the quality concept of "pharmaceutical equivalence by design.” This article illustrates through several examples how this QbD element in the evaluation of modified-release drug products enhances the current framework to ensure generic drug product equivalence. It achieves this by complementing the traditional paradigm, "equivalence by testing,” where product equivalence is based upon inferences from a limited bioequivalence study, to one that also considers whether the drug product was developed to be an equivalent to the RLD, using appropriate quality surrogates that target "pharmaceutical equivalence by design.” Springer Science+Business Media, LLC (outside the USA), 2011 generic drugs nationallicence modified release nationallicence pharmaceutical equivalence nationallicence quality by design (QbD) nationallicence quality target product profile (QTPP) nationallicence therapeutic equivalence nationallicence Raw André Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, 20855, Rockville, Maryland, USA aut Lionberger Robert Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, 20855, Rockville, Maryland, USA aut Yu Lawrence Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, 20855, Rockville, Maryland, USA aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/7(2011-07-01), 1445-1453 0724-8741 28:7<1445 2011 28 11095 https://doi.org/10.1007/s11095-011-0397-6 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-011-0397-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Raw André Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, 20855, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Lionberger Robert Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, 20855, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Yu Lawrence Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, 20855, Rockville, Maryland, USA aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/7(2011-07-01), 1445-1453 0724-8741 28:7<1445 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer