Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs

In this study, a data mining exercise has been conducted with regulatory submissions of Investigational New Drug (IND) Applications, NDAs, and Abbreviated New Drug Applications (ANDAs) containing MARS data. The case studies presented herein demonstrate how MARS data has been applied to regulatory scenarios involving prediction of retest and/or shelf-life, bridging major development changes, and confirming that no degradation has been observed or predicted. Using the assumption of a linear time trend for those cases that do not display sufficient degradation to conduct MARS for projection of an expiration date, an analysis of covariance (ANCOVA) model is developed and described herein to test the hypothesis of zero slope by a p-value method. Our results show that the application of MARS adequately supported establishment of a tentative commercially viable retest date/shelf-life, thus enabling earlier access to critical drugs for patients with unmet medical needs.PMID:36631718 | DOI:10.1208/s12249-022-02498-0

Source: AAPS PharmSciTech - January 11, 2023 Category: Drugs & Pharmacology Authors: M Scott Furness Hong Cai Sithamalli Chandramouli Mariappan Chelliah Xiao Hong Chen Debasis Ghosh Shaobo Liu Sherita McLamore Ramnarayan Randad Meiyu Shen Source Type: research