Process / pipelineBiopharmaceutics
Dissolution f1/f2 Similarity Factor
The f1 and f2 factors are dimensionless statistical measures developed by Moore and Flanner to quantify the similarity between two dissolution profiles. Adopted by regulatory agencies (FDA, EMA) as the gold standard for comparing dissolution curves, these factors enable rapid assessment of whether formulation changes significantly impact drug release.
Open in MethodMindSoonVideoSoon
Read the full method
Members only
Sign inSign in with a free account to read this section.
Sources
- Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link ↗
- Shah, V. P., Tsong, Y., Sathe, P., & Liu, J. P. (1998). In vitro dissolution profile comparison--statistics and analysis of the similarity factor, f2. Pharmaceutical Research, 15(6), 889-896. DOI: 10.1023/A:1011976615750 ↗