Eli Lilly & Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Risk-Based Predictive Stability–An Industry Perspective
A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.