FDA Revises Eligibility for BA/BE Study Waivers
Tuesday, May 12, 2015
Source: FDA News
Sponsors of INDs, NDAs, ANDAs and supplemental applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product.
These immediate-release solid oral drugs fall into the third class of a biopharmaceutics classification system that ranks them both by solubility and intestinal permeability. By comparison, Class 1 drugs have high solubility and high permeability and Class 2 drugs have low solubility but high permeability. Class 4 drugs aren’t overly efficient at either of these.
Sponsors looking to waive bioavailability and bioequivalence studies for Class 3 drugs should include evidence that the drug works in the body, the guidance says. This may include a comparison of the drug’s safety and effectiveness with that of other formulations, such as oral liquids, suspensions or injections.