By Susan Smith
Published in: Sci of Stability Conference
Published on: August 14, 2019
Conclusions: • Product knowledge underpins understanding of the stability-related risks associated with the product • Scientific rationale combined with product understanding has been used to leverage lean stability strategies throughout development • However, a unified regulatory position to science- and risk-based stability strategies does not exist at present, potentially leading to conservatism within drug companies • Although challenges remain both within companies and externally from regulators these case studies demonstrate that many scientifically sound lean strategies are acceptable from a regulatory perspective Key Words: Biologic, Bracket, Annual