Kim Huynh-Ba*, Pharmalytik LLC, and Christopher Latoz, Hollister Incorporated*Corresponding Author: kim.huynhba@pharmalytik.comAbstractPharmaceutical products require expiration dates and storage conditions on their labels, determined through stability studies conducted from clinical trials through post-approval. These studies ensure that any chemical, physical, or microbiological changes over time do not affect the product’s quality, safety, or efficacy. ICH Q1A(R2) provides […]
