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
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
November 11th 2024With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.
