Optimizing Stability Data Package to Facilitate NDA/MAA Approval

Abstract

The stability data package is often the last piece completed prior to finalization of the Chemistry, Manufacturing and Controls (CMC) section of an NDA/MAA regulatory submission. The data contained in the stability section is used to determine the proposed drug product expiration date and API retest date, to establish any special requirements for packaging, to facilitate justification of the API and product specifications, as well as to provide commitments for the commercial stability program. Well planned and executed stability studies, as well as an accurate evaluation, and well thought out presentation of the data will aid regulatory review. This paper focuses on the stability studies required to meet the current regulatory guidelines with an emphasis on the design of the studies and the evaluation, interpretation and presentation of the data.