Leveraging Phoenix for Dissolution Testing to Meet Regulatory Guidelines

Dissolution tests are widely used in the pharmaceutical industry to assess the influence of the formulations and manufacturing process on drug release. For example, they are used to assess the influence of aging on the formulation during stability testing. In bioequivalence studies, dissolution testing is performed to select which reference batches best match the test formulation. Finally, in some cases, these tests can be used as a surrogate for in vivo data of immediate release formulations of BCS class I and III drugs or to attain a biowaiver of strength.

The standard statistical test for comparing in vitro dissolution data with in vivo pharmacokinetic data is the F2 test. What tools are available for formulation scientists to perform F2 testing? And what regulatory guidelines must be considered when performing these tests?

Watch this webinar where Prof JM Cardot explained the following:

  • When the F2 test is used to compare dissolution profiles
  • The constraints of the F2 Test
  • How to program this test in Phoenix
  • Differences in requirements between regulatory agencies