This would require a new licensing application, including conducting of new manufacturing validation studies; and pre-clinical and clinical studies.
这将需要提出新的许可申请，包括开展新的生产验证研究，以及临床前和临床研究。
Method validation studies establish proof that a method is suitable for its intended purpose.
方法验证研究是建立该方法适合于其使用目的的证明。
FDA expects firms to conduct the validation studies in accordance with the protocols and to document the results of studies.
FDA要求公司应按照方案来进行验证研究，并以书面形式记录这些研究结果。
These temporal phenotypic plaque alterations should be taken into account for biomarker and therapeutic target validation studies using human atherosclerotic plaques.
在使用人类粥样硬化斑块作为生物标志物和治疗标靶的有效性研究中，应该考虑这些暂时性的斑块类型的改变。
It is expressly mentioned that some process validation studies may beconducted on pilot-scale batches (corresponding to at least 10% or 100 000units whichever is the greater).
文字中提到，一些工艺验证研究可能是在中试批次上进行的（对应至少10%或10万剂单位，取大者）。
The manufacturer may obtain assurance that a product is of Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing process and from in-process controls.
生产厂商可以从数据的来源上获得产品符合药典质量的保证，如来源于生产工艺验证研究的数据以及中控的数据。
Validation studies should be performed across the range of profile time points.
所进行的验证研究应横跨溶出曲线时间点范围。
Validation studies show that SIMSIO provides a good representation of actual conditions.
验证结果显示，SIMSIO可以较好的描述交叉口的实际交通状况。
Validation studies show that SIMSIO provides a good representation of actual conditions.
验证结果显示，SIMSIO可以较好的描述交叉口的实际交通状况。
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