Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.
The recent FDA guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, like tablets, capsules, and granules/powders for oral suspension.
Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. Applicants are encouraged to check the regulatory authority or authorities when an alternate approach is taken.
Source: FDA
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
