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.

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Sources

  1. Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link
  2. 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

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Referenced by

ScholarGateDissolution f1/f2 Similarity (Dissolution f1/f2 Similarity Factor). Retrieved 2026-06-04 from https://scholargate.app/en/pharmacology/dissolution-f1-f2-similarity