As stated in the recent FDA whitepaper on Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs, "completion of stability data requirement is one of the most observed challenges for applicants of New Drug Applications (NDAs) with an expedited review designation". In the meantime, regulatory agencies are also starting to realize that the current regulatory stability guidelines (including ICH) do not reflect advancement in the science of stability and modern analytical technologies and statistical tools. A more holistic patient centric science risk-based approach is needed to better stability understanding by utilizing historical data, prior knowledge, modeling and a risk assessment process for assignment of retest period and shelf-life for a new product and assessment of the impact of post approval changes. It is also important to take in considerations from patient experience perspective include how the drug is used by the patient (In-use study), distributed (including last-mile consideration, temperature excursions, and bulk hold time) in addition to regular ICH stability conditions for support of product shelf life. Explanation and various case studies will be given in the presentation to address different innovative tools and approached developed in the industry over the years including accelerated predictive stability (APS), stability modeling, stability risk assessment, Lean stability, and stability budgeting. These approaches will be able to enable acceleration of development of high quality new drug products that truly meet patient needs.
Learning Objectives:
Upon completion, participant will be able to have better understanding of different stability considerations to support not only drug product shelf life but also patient in-use, product distribution needs
Upon completion, participant will be able to develop a holistic approach to stability understanding build upon prior knowledge, predictive modeling and a risk assessment process
Upon completion, participant will be taking a number of innovative tools including stability budgeting, stability predictive modeling, and Lean stability into considerate when developing end-to-end stability strategy for product development