In Part I of this two-part series, the authors discuss the need to follow GMPs for lipid-vesicle fabrication that result in size uniformity, delivery of sufficient drug concentration, and stability.
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.