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Accurately forecasting long-term stability from accelerated data

29 Apr 2026
Formulation & Stability
  • How reliably can accelerated stability studies predict long-term product behavior under real-time conditions?
  • Which degradation pathways observed under accelerated conditions are truly representative of long-term storage risks?
  • What statistical or modeling approaches best link accelerated data to accurate shelf-life predictions?
  • How can uncertainty and variability be quantified when extrapolating long-term stability from short-term studies?
  • What level of accelerated stability evidence is sufficient to satisfy regulatory expectations for expiry dating?