Where such data are not available, and drug release cannot be shown to be independent of in vitro test conditions, then acceptance criteria should be established on the basis of available batch data.〔【出典】ICHガイドライン 〕
Close to the Toyohashi Bridge, under which the water flows vigorously, there is the Ino Tadataka Memorial Hall, which displays the achievements of Ino Tadataka （1745-1818）, a geographical surveyor who made the first survey maps of Japan."IC015010", "2280299"
However, this extrapolation assumes that the same degradation relationship will continue to apply beyond the observed data.〔【出典】ICHガイドライン 〕
Limited extrapolation of the real time data from the long term storage condition beyond the observed range to extend the re-test period can be undertaken at approval time, if justified.〔【出典】ICHガイドライン 〕