Lean Stability Approaches in Pharmaceutical Product Development, Registration, and Post-marketing CMC Change Management; Industry Survey Insights
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DOI: 10.1007/s12247-021-09540-x
Abstract: This paper summarizes results from a recent pharmaceutical industry survey to understand the adoption status of science- and risk-based approaches in pharmaceutical stability (lean stability) in regulatory submissions across the full pharmaceutical product life cycle… read more here.
Keywords: stability; product; industry survey; lean stability ... See more keywords