Development of in vitro - in vivo correlations for newly optimized Nimesulide formulations

摘要: Use of the human volunteers in bioequivalence studies is being discouraged by Food and drug administration after introduction biowaiver approaches. In-vitro in-vivo correlation (IVIVC) with level A accepted for registration new molecules. In present study deconvolution technique numeric approaches was applied compressing vitro validating 100mg Nimesulide immediate, intermediate slow release tablets. Single centered, crossover, randomized conducted four phases a two-week washout period to obtain plasma concentration data administrating test reference products male healthy volunteers. KineticaTM 4.4.1 (Thermoelectron corp, USA) used calculation two ways ANOVA 90% CI from both log transformed non- Phoenix WinNonlin 7 it's IVIVC toolkit version 7.0 application IVIVC. Results revealed that individual internal percentage prediction error AUCinf Cmax were found be 15. order predict point between fraction dissolved absorbed, their mean r2 value > 0.9112 which showed linear slightly alkaline pH.