Читать книгу Mutagenic Impurities - Группа авторов - Страница 91
2.4.4.1 Question 4.1
Оглавление| Question | Answer |
|---|---|
| What does “significant increase in clinical dose” mean in “4.3 Changes to the Clinical Use of the Marketed Products”? | Any increase in dose of the API that would increase any mutagenic impurity to levels above the acceptable limits is considered significant (see tables 2 and 9 and the addendum). In such cases a reevaluation of the mutagenic impurity limits is recommended. |
This essentially means that any increase in the dose warrants a re‐evaluation of the mutagenic impurity limits.
