caa a22 4500 445313765 CHVBK 20180317142639.0 cr unu---uuuuu 170323e20110501xx s 000 0 eng 10.1007/s11095-011-0377-x doi (NATIONALLICENCE)springer-10.1007/s11095-011-0377-x In Vivo Bioequivalence and In Vitro Similarity Factor (f2) for Dissolution Profile Comparisons of Extended Release Formulations: How and When Do They Match? [Elektronische Daten] [John Duan, Kareen Riviere, Patrick Marroum] ABSTRACT: Purpose: To investigate how likely two extended release formulations are to be bioequivalent when they demonstrate f2 similarity. Method: Dissolution profiles were simulated using the Weibull model and varying model parameters around those of a reference profile. The f2 values were calculated for the comparisons of each simulation with the reference profile. The in vivo inputs obtained from an in vitro-in vivo correlation model were convolved with a unit impulse response function. The AUC, Cmax, and Tmax from each simulated in vivo concentration profile were compared to the reference profile. The AUCR (AUC ratio) and CmaxR (Cmax ratio) were determined. The consistency between f2 and bioequivalence was investigated. Results: The relationships between AUCR, CmaxR, f2 and the Weibull model parameters demonstrate that the bioequivalence regions enclosed by the contour lines of 80% and 125% of AUCR and CmaxR were generally close to the regions enclosed by the f2 = 50 contour line, but did not exactly match, especially when Dmax and B deviated from the reference values. Conclusions: When f2 is used for in vitro dissolution profile comparison, the completeness of the dissolution profiles should not differ more than 10%, and the shapes of the dissolution profiles should not be significantly different. Springer Science+Business Media, LLC (outside the USA), 2011 bioequivalence nationallicence dissolution nationallicence f2 similarity factor nationallicence IVIVC nationallicence modeling and simulation nationallicence Duan John Office of New Drug Quality Assessment, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 1620, 20993, Silver Spring, Maryland, USA aut Riviere Kareen Office of New Drug Quality Assessment, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 1620, 20993, Silver Spring, Maryland, USA aut Marroum Patrick Office of New Drug Quality Assessment, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 1620, 20993, Silver Spring, Maryland, USA aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/5(2011-05-01), 1144-1156 0724-8741 28:5<1144 2011 28 11095 https://doi.org/10.1007/s11095-011-0377-x text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-011-0377-x text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Duan John Office of New Drug Quality Assessment, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 1620, 20993, Silver Spring, Maryland, USA aut NATIONALLICENCE 700 1- Riviere Kareen Office of New Drug Quality Assessment, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 1620, 20993, Silver Spring, Maryland, USA aut NATIONALLICENCE 700 1- Marroum Patrick Office of New Drug Quality Assessment, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 1620, 20993, Silver Spring, Maryland, USA aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/5(2011-05-01), 1144-1156 0724-8741 28:5<1144 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer