The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.