Shelf life extensions clin.trial.

[Natuli]

Подскажите, пожалуйста, как правильно назвать "Shelf life extensions" по-русски в официальных документах для Минздрава например? именно в рамках клинических исследований

Question: Shelf life extensions
Which information should be included in the file in order to make shelf life extensions without notification of a substantial amendment?

Answer:
The criteria based on which it is intended to extend shelf life during an on-going study should be given. The information should include extension protocol limiting the maximum time period for extrapolation. In the case of any significant negative trend for stability data observed during long-term and accelerated testing, the sponsor should commit to notify any shelf life extension as a substantial amendment.

[natalitom]

Хоть для Минздрава, хоть для кого другого это продление срока годности.

[Natuli]

Спасибо, продление срока годности исследуемого препарата (IMP)?