You need data from at least 12 dissolution experiments. To perform F1/F2 tests, you need to first determine whether your data fits the prerequisites. To consider the profiles similar, each F1 value must be less than 10-15% and for F2, the final F2 value must be greater than 50%. It’s a more complicated calculation than the F1 test.
#Dissolution calculation tool full
The F2 is a similarity function over the full profile. The F1 test measures the relative error between curves. If dissolution takes more than 15 minutes, you must use statistical tests (either F2 or F1/F2) to show that the two dissolution profiles are equivalent. If the drug is more than 85% dissolved within 15 minutes, the test and reference profiles can be considered similar without further statistical evaluation. When comparing drug dissolution profiles, you need to consider your drug’s pharmaceutical properties. Shah Statistical Assessment of mean differences between two dissolution data sets, Drug Information Journal, 1996, 30, pp. Shah In vitro dissolution profile comparison: statistics and analysis, model dependent approach Pharmaceutical Research, 1996, 13, 12 Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage Forms Center for Drug Evaluation and Research (CDER) September 1997.EMEA Note for guidance on the investigation of bioavailability and bioequivalence CPMP/EWP/QWP/ 1401 / 98/Rev1.You may want to read the European and American guidances on this topic: Numerous regulatory guidances have been written about comparing dissolution profiles. While, the FDA requires pharma companies to use both the F2 and F1 test, the EMEA and other regulatory agencies only require the F2 test. This test was developed by scientists in collaboration with U.S. The F2 test is a statistical test used to compare dissolution profiles. The F2 test and regulatory considerations For drug-containing implants, dissolution can take up to several days or longer. For an extended-release formulation, the sampling time will be spread out over hours. An immediate-release (IR) formulation requires taking many samples over a short time period. The dissolution sampling times depend on the drug’s formulation. The results of dissolution tests are plotted as the percent dissolved vs. Thus, dissolution tests can be used for tablets, implants containing hormones, injectable formulations, and some medical devices such as stents. Considerations for dissolution testsĭissolution tests are required for all, non-liquid, drug dosage forms containing an active ingredient that is absorbed systemically to have systemic activity. In this blog post, I’ll discuss some important considerations for performing dissolution and F2 tests and explain how they can inform your drug development program. The F2 statistical test is often used to make this comparison. Comparison tests are also required, when the dissolution is not very rapid, to compare dissolution curves for biowaivers. Generic drug developers are also required to show bioequivalence between the branded drug (reference product) and the generic version (test product). When companies make changes to drug products (particle size, excipients, manufacturing process, equipment, etc), health authorities often require comparing dissolution profiles to determine if the reference and test products are equivalent. Dissolution testing is a standard tool in a formulation scientist’s arsenal.
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