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Subject: clinical formulation gen. Контекст: "Pre-clinical studies should focus on evaluating the safety of the active ingredient, clinical forumulation components, and stability, as well as any safety issues specific to the route of administration. Stability must be demonstrated for the clinical formulation for the duration of use in the first clinical study; a full ICH stability program per ICH Q1A is not required at this point."Спасибо. |
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link 22.10.2011 11:20 |
| ну, например, на оценке безопасности активного ингредиента и других компонентов лекарственной формы, предназначенной для клинического применения... |
| Спасибо! Меня здесь, в основном, clinical интересовало. |
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