Term Stability Studies (25 ± 2 °C/60± 5%RH ) And The Accelerated ...

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FAQ Drugs HomeFAQDrugs The long- term stability studies (25 ± 2 °C/60± 5%RH ) and the accelerated stability conditions are (40 ± 2 °C/75± 5%RH ) are performed using three drug substance batches. If the stability result of one of three batches has a significant change during the stability testing period in the accelerated studies, what actions should be undertaken? (“Significant change” for a drug substance is defined as failure to meet its specification.) 刊登日期：2020-07-23 | 點閱次數 : 3395 次

The intermediate stability study results for three batches should be provided. In addition, analysis and discussion of failed stability study should be provided. (Referenced to ICH Q1A)

(中文版)

What information should be included in the DMF/API application data for a startin Should all analytical methods listed in a drug substance specification be fully v

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