Stability & Shelf-Life Prediction
Stability testing is mandated by ICH guidelines to determine expiration dates and storage conditions. However, linear regression alone often fails to account for non-linear degradation or batch variability.
What we do
Regression Modeling
Use statistical regression to predict product stability over time under various conditions.
Accelerated Degradation Analysis
Assess product degradation under stress conditions to estimate shelf-life.
Time-Series Forecasting
Forecast future stability trends using historical data and time-series models.
Monte Carlo Simulations
Perform simulations to assess the probability of different stability outcomes.
Regulatory alignment
Fully compliant with ICH Q1A(R2), Q1E, Q5C, and WHO stability guidelines.
Business Value
Extends shelf life via robust modeling, reduces wastage, ensures ICH compliance, and improves logistics planning.