How to Design of In-use Shelf Life for Solid Oral Dosage Forms in Multi-dose Containers?
Q. When is it necessary to perform in-use stability studies on solid oral dosage forms such as tablets and capsules in multi-dose containers? Ans. Data on the in-use stability of such products should be generated through a dedicated in-use stability study under long-term conditions when there is an indication from stability and/or stress studies that…