Читать книгу Mutagenic Impurities - Группа авторов - Страница 58

This applies where there is a change in either dose or duration (increase) or a change in indication from a serious or life‐threatening condition to an indication for a less serious condition where the existing impurity acceptable intakes (AIs) may no longer be appropriate. An obvious example of the latter would be in instances where an anticancer treatment used in late stage disease for which limits have been based on ICH S9 [8] is then used for either a revised patient population, e.g. adjuvant therapy, or a new non‐oncology indication.

Another important point that relates to the innate conservatism of the TTC is the statement that changes to patient population in terms of age do not trigger the need for reassessment and revision of limits. Previously the draft FDA guideline [4] had indicated the need to modify limits for pediatric indications. This has been removed from the ICH M7 guideline.

In addition, the earlier FDA draft guideline had indicated that different limits may be applicable dependent on the planned route of delivery, i.e. oral, pulmonary, etc. Similarly, this has been removed from the ICH M7 guideline.