＊ If a bridging study, properly executed, indicates that a different dose in the new region results in a safety and efficacy profile that is not substantially different from that derived in the original region, it will often be possible to extrapolate the foreign data to the new region, with appropriate dose adjustment, if this can be adequately justified （e.g., by pharmacokinetic and/or pharmacodynamic data）.〔【出典】ICHガイドライン 〕
In 2003 and 2004, Japan's total fertility rate was 1.29 （see section above on Japanese Population Dynamics）."NIPO-157", "2355005"
based on anticipated demographics and lifestyle changes in the 21st century
A sponsor may wish to leave the assessment of pharmacokinetics, pharmacodynamics, dosage and dose regimens in populations relevant to the new region until later in the drug development program.〔【出典】ICHガイドライン 〕
The timing of the collection of ECGs and the study design （e.g., single or multiple dose, duration） of the 'thorough QT/QTc study' should be guided by the available information about the pharmacokinetic profile of the drug.〔【出典】ICHガイドライン 〕
If the clearance pathways of a medicinal product are well established and the ontogeny of the pathways understood, age categories for pharmacokinetic evaluation might be chosen based on any "break point" where clearance is likely to change significantly.〔【出典】ICHガイドライン 〕
In such cases, pharmacokinetic studies in the relevant age groups of pediatric patients likely to receive the medicinal product, together with safety studies, may be sufficient to provide adequate information for pediatric use.〔【出典】ICHガイドライン 〕