I took a job teaching English on the campus of a seaside college while the four of us continued our bicultural experiences in a new setting.〔【出典】『バイリンガル・子育て法』（スティーブン・ベリエ著）◆【出版社】株式会社ヤック企画 〕"YA09-164", "2342264"

The clinical experience with other members of the drug class in the new region will also contribute to the assessment of the medicine's sensitivity to ethnic factors.〔【出典】ICHガイドライン 〕

Results from the foreign clinical trials could comprise most, or in some cases, all of the clinical data package for approval in the new region, so long as they are carried out according to the requirements of the new region.〔【出典】ICHガイドライン 〕

new regionalism

＊ If the bridging study shows that dose response, safety and efficacy in the new region are similar, then the study is readily interpreted as capable of "bridging" the foreign data.〔【出典】ICHガイドライン 〕

＊ If the bridging study designed to extrapolate the foreign data is not of sufficient size to confirm adequately the extrapolation of the adverse event profile to the new population, additional safety data may be necessary （section 3.2.4）.〔【出典】ICHガイドライン 〕

＊ A bridging study to assess efficacy, such as a dose-response study, could be powered to address the rates of common adverse events and could also allow identification of serious adverse events that occur more commonly in the new region.〔【出典】ICHガイドライン 〕

＊ 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 〕

The regional regulatory authority would assess the clinical data package, including the foreign data, as to whether or not it meets all of the regulatory standards regarding the nature and quality of the data, irrespective of its geographic origin, i.e., data generated either totally in a foreign region （or regions） or data from studies conducted both in a foreign and the new region to which the application is being made.〔【出典】ICHガイドライン 〕

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 〕

Historically, this has been one of the reasons, therefore, the regulatory authority in the new region has often requested that all, or much of, the foreign clinical data in support of registration be duplicated in the new region.〔【出典】ICHガイドライン 〕

Acceptance in the new region of such foreign clinical data may be achieved by generating "bridging" data in order to extrapolate the safety and efficacy data from the population in the foreign region（s） to the population in the new region.〔【出典】ICHガイドライン 〕

However, concern that ethnic differences may affect the medication's safety, efficacy, dosage and dose regimen in the new region has limited the willingness to rely on foreign clinical data.〔【出典】ICHガイドライン 〕

The acceptability of the foreign clinical data component of the complete data package depends then upon whether it can be extrapolated to the population of the new region.〔【出典】ICHガイドライン 〕

Close monitoring of such a trial would allow recognition of such serious events before an unnecessarily large number of patients in the new region is exposed.〔【出典】ICHガイドライン 〕

It is critical to appreciate that this guidance is not intended to alter the data requirements for registration in the new region; it seeks to recommend when these data requirements may be satisfied with foreign clinical data.〔【出典】ICHガイドライン 〕

In most cases, a single trial that successfully provides these data in the new region and confirms the ability to extrapolate data from the original region should suffice and should not need further replication.〔【出典】ICHガイドライン 〕

A bridging study is defined as a study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the population in the new region.〔【出典】ICHガイドライン 〕

If the regions are ethnically dissimilar and the medicine is ethnically sensitive but extrinsic factors are generally similar （e.g., medical practice, design and conduct of clinical trials） and the drug class is a familiar one in the new region, a controlled pharmacodynamic study in the new region, using a pharmacologic endpoint that is thought to reflect relevant drug activity （which could be a well-established surrogate endpoint） could provide assurance that the efficacy, safety, dose and dose regimen data developed in the first region are applicable to the new region.〔【出典】ICHガイドライン 〕

It may be easier to conclude that the pharmacodynamic and clinical behaviour of a medicine will be similar in the foreign and new regions if other members of the pharmacologic class have been studied and approved in the new region with dosing regimens similar to those used in the original region.〔【出典】ICHガイドライン 〕

Item 1 Statutory Entrusted Affairs prescribed in Article 2, paragraph 9, item 1 of the new Local Government Act shall, in addition, be created to the minimum possible extent, and such affairs listed in Appended Table I of the new Local Government Act and those provided for by Cabinet Order enacted under the new Local Government Act shall be examined from the perspective of promoting decentralization and be reviewed as appropriate.〔【出典】日本法令外国語訳データベースシステム 〕

Even though the foreign clinical data demonstrate efficacy and safety in the foreign region, there may occasionally remain a safety concern in the new region.〔【出典】ICHガイドライン 〕

All data in the clinical data package, including foreign data, should meet the standards of the new region with respect to study design and conduct and the available data should satisfy the regulatory requirements in the new region.〔【出典】ICHガイドライン 〕

At first, Thailand's Mass Rapid Transit Authority was planning to begin regular service on the new subway line on August 12, Queen Sirikit's birthday.〔【出典】Catch a Wave, 2004年4月23日号◆【出版社】株式会社浜島書店 〕

A bridging study for efficacy could provide additional pharmacokinetic information in the population of the new region.〔【出典】ICHガイドライン 〕

When no bridging study is needed to provide clinical data for efficacy, a pharmacokinetic study in the new region may be considered as a bridging study.〔【出典】ICHガイドライン 〕

This guidance is based on the premise that it is not necessary to repeat the entire clinical drug development program in the new region and is intended to recommend strategies for accepting foreign clinical data as full or partial support for approval of an application in a new region.〔【出典】ICHガイドライン 〕

This guidance describes how a sponsor developing a medicine for a new region can deal with the possibility that ethnic factors could influence the effects （safety and efficacy） of medicines and the risk/benefit assessment in different populations.〔【出典】ICHガイドライン 〕

This guidance proposes that when the regulatory authority of the new region is presented with a clinical data package that fulfils its regulatory requirements, the authority should request only those additional data necessary to assess the ability to extrapolate foreign data from the Complete Clinical Data Package to the new region.〔【出典】ICHガイドライン 〕

Safety concerns could include the accurate determination of the rates of relatively common adverse events in the new region and the detection of serious adverse events （in the 1% range and generally needing about 300 patients to assess）.〔【出典】ICHガイドライン 〕

Depending on the situation, the trial could replicate the foreign study or could utilize a standard clinical endpoint in a study of shorter duration than the foreign studies or utilize a validated surrogate endpoint, e.g., blood pressure or cholesterol （longer studies and other endpoints may have been used in the foreign phase III clinical trials）.〔【出典】ICHガイドライン 〕

If a sponsor needs to obtain additional clinical data to fulfil the regulatory requirements of the new region, it is possible that these clinical trials can be designed to also serve as the bridging studies.〔【出典】ICHガイドライン 〕

Once a clinical data package fulfils the regulatory requirements of the new region, the only remaining issue with respect to the acceptance of the foreign clinical data is its ability to be extrapolated to the population of the new region.〔【出典】ICHガイドライン 〕

Additional studies conducted in any region may be required by the new region to complete the clinical data package.〔【出典】ICHガイドライン 〕

If pharmacodynamic data suggest that there are interregional differences in response, it will generally be necessary to carry out a controlled trial with clinical endpoints in the new region.〔【出典】ICHガイドライン 〕

Pharmacokinetic assessment could be accomplished by formal pharmacokinetic studies or by applying population pharmacokinetic methods to clinical trials conducted either in a population relevant to the new region, or in the new region.〔【出典】ICHガイドライン 〕

When the regulatory authority or the sponsor is concerned that differences in ethnic factors could alter the efficacy or safety of the medicine in the population in the new region, the sponsor may need to generate a limited amount of clinical data in the new region in order to extrapolate or "bridge" the clinical data between the two regions.〔【出典】ICHガイドライン 〕