Stability parameter estimation at ambient temperature from studies at elevated temperatures

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Résumé

The determination of specific kinetic constants ki in pH–profile studies is often undertaken at ambient temperature. However, when dealing with a drug substance that is stable at ambient temperature, the pH–profile study is conducted at a chosen elevated temperature and the kinetic parameters are given at this particular elevated temperature. But in stability studies we generally need kinetic constants at ambient or storage temperature for practical reasons (information and storage conditions of formulation). To assess this ambient kinetic information from studies at elevated temperatures, cumulative sequential steps are usually employed with very few statistical concerns on the final estimates. The statistical problems on these final estimates in cumulative procedures are highlighted in many papers. Because these stability parameters are useful for drug formulation and storage conditions, good …

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