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How freing clinical data package can be utilized to get a speedy approval of the new drug

机译：如何利用如何利用临床数据包来快速批准新药

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In a broad sense,ethnic factors represent the fundamental problems in the acceptability of foreign clinicsl data.The aminstays of the harmonized final document about ethnic factors in the acceptability of foreign clinical data include a complete clinical data padkage and a bridging study (for efficacy and/or for safety).A clinical data package that meets all of the regional regulatory requirements is defined as a complete chlinical data package for submission and potential approval,irrespective of its geographic origin.The acceptability of the foreign clinical data component of the complete data package depends upon whether it cam be extrapolated to the population of the new region.Ethnic differences can be classified into intrinsic and extrinsic factors.In many cases extrinsic factors,such as medical practics and sustom,might more influence the availability of foreign clinical data than intrinsic factors.To overcome the difficulties inherent in ethnic differences,the bridging study concept was created.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 regiment that will allow an ectrapolation of the foreign clinical data to the population of the new region.When a bridging study is designed,it is important to consider first which clinical studies in the foreign clinical data package are intended to be bridged or extrapolated.Then,the counterpart study should be selected from among available foreign clincial studies as the foundation of the bridge.The bridging study should be performed in the new region by the same or similar design to the design of the counterpart study in terms of subjects included,the duration of study,endopont(s),evaluation method of clinical effects,etc.A bridging study could be relatively small,but the results of the study should be comparable with those of the counterpart of foreign clinical studies in all respects.The Clinical Trials Advice Division of the Organizatio for Pharmaceutical Safety and Research has been dealing with consultations about beidging studies since February 1998.Since then,Unmbers of consultations in relation to bridging studies have steadily been increasing.However,employing bridging study strategy is not always possible for various reasons.It should be noticed that the bridging study is not the only way to utilize efficiently foreign clinical data to promote the new drug approval,although the bridging study strategy may be the best desirable way,when possible,in order to utilize extensively foreign clinical data package.
机译：在一个广泛的意义上，民族因素代表了外国诊所数据可接受性的基本问题。外国临床数据可接受性的民族因素的统一最终文件的Aminstays包括完整的临床数据帕库克和桥接研究（用于疗效和效力/或安全）。符合所有区域监管要求的临床数据包被定义为提交和潜在批准的完整养分数据包，无论其地理原产地如何。完整数据的外国临床数据组件的可接受性包装取决于它是否将凸轮推断为新区域的人口。民族差异可以分为内在和外在因素。在许多情况下，如医学实践和浮渣，可能会影响外国临床数据的可用性而非内在的因素。克服族裔差异所固有的困难，桥接研究有限公司NECTECT被创造了。桥接研究被定义为在新地区进行的研究，以提供药效学或临床数据，以允许外国临床数据对新地区的群体进行分析。设计桥接研究时，重要的是考虑外国临床数据包装中的哪些临床研究旨在桥接或推断。该研究，应选自分区研究作为桥梁的基础。 。桥接研究应在新地区进行相同或类似的设计，对对手研究的设计，在受试者方面包括，研究持续时间，临床效果的评估方法等。桥接研究可能相对较小，但研究结果应与各方面的外国临床研究对应的结果相媲美。临床试验咨询部门关于制药安全和研究的组织一直在处理自1998年2月以来的敌对研究的磋商。然后，随后与桥接研究有关的磋商稳步增加。无论何种，都没有出于各种原因持有桥接研究战略。应该注意的是，桥接研究不是利用有效的外国临床数据来促进新药物批准的唯一方法，尽管桥接研究策略可能是最好的理想的方式，尽可能有可能，以利用广泛的外国临床数据包。

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