EVALUATION OF STABILITY DATA PER ICH Q1E: Application of Guidance to Drive Statistical Strategies
Laura Pack, Sr. Director, QC & Statistics, Rezolute, Inc.
Laura did a masterful job of un-packing ICH Q1E, pointing out that when it comes to statistics, Stabilitarians and Statisticians can be speaking different languages using the same terms, but having different meanings. Laura covered and interpreted the provisions of the guidance, pointing out typical pain points, and methods of successful application.
With statistics being the basis of the shelf-life and storage stories we want to tell about our product in convincing regulatory authorities, do we maximize our relationships and interaction with our statisticians, or have we underestimated the critical role they play in our process?