By Jon V. Beaman
Published in: American Pharmaceutical Review
Published on: August 1, 2010
Introduction: This article examines the decisions to be made regarding the design of a stability strategy during development and some alternative approaches, compared to those traditionally followed, are proposed as being more scientifically rigorous. Following these approaches would lead to better product understanding and robustness as well as to a reduction in the number of scientifically redundant stability studies.
