f2 bootstrap (for the comparison of highly variable dissolution profiles) 非模型依赖多变量置信 区间法(for the comparison of highly variable dissolution) profiles) “worst case scenario”, which consists in comparing the lower limit of a CI [f2 or E(f2)] to the cut-off similarity value of 5...
The objective of this article is to compare and contrast the international expectations associated with the model-independent similarity factor approach to comparing dissolution profiles. This comparison highlights globally divergent regulatory requirements to meet local dissolution similarity requirements. In ...
In Vitro Dissolution Profile Comparison—Statistics and Analysis of the Similarity Factor, f2 To describe the properties of the similarity factor (f2) as a measure for assessing the similarity of two dissolution profiles. Discuss the statistical pro... VP Shah,T Yi,P Sathe,... - 《...
In vitro dissolution similarity has been suggested as a surrogate for assessing equivalence between the pre-changed and post-changed formulations for postapproval changes of a drug. The difference factor f1, based on the absolute mean difference, has been proposed as a criterion for evaluating ...
2)f2 factorf2因子 1.Methods:The dissolution profiles of model drug were drawn through detecting samples by UV method,f2 factor was employed to evaluate the similarity of dissolution profiles of different formulations in order to optimize the formulation.方法:以紫外分光光度法对格列齐特推拉式渗透泵的...
Using the similarity factor in practice: A critical revision and suggestions for its standard error estimation The purpose of this research was to develop new procedures with the aim of improving the usage of the similarity factor f 2 in dissolution data analysis, a... OFSO Jordi - 《...
of sodium dodecyl sulfate, different concentrations of sodium chloride and different pH dissolution media on the dissolution curve were investigated, and the best dissolution conditions were selected. The similarity of the dissolution curve was evaluated using the dissolution curve similarity factor method....
maleate capsules and imported products were determined in different conditions,and the resemblance of dissloution curve were compared by similarity factors(f2).Results The similarity factors(f2) under various conditions were over 60.Conclusion The dissolution curve of two products was in good ...
2) f2 factor f2因子 1. Methods:The dissolution profiles of model drug were drawn through detecting samples by UV method,f2 factorwas employed to evaluate the similarity of dissolution profiles of different formulations in order to optimize the formulation. ...
Thus, after taking the real part as in (8.35), the final velocity distribution for Stokes’ second problem is (8.38)u(y,t)=Uexp{−yω2ν}cos(ωt−yω2ν). The cosine factor in (8.38) represents a dispersive wave traveling in the positive-y direction, while the exponential term ...