*Note: These are examples. All therequired documents should be identified for the different tasks.
注意:以上为示例。针对不同的任务，应该识别出所有需要的文件。
Appendix 2 Exampleof possible experimental designs and acceptance criteria for analytical testing
附录2. 分析测试可能的实验设计和接受标准示例
The table below provides an example of possible experimental designs andacceptance criteria for analytical testing. The numbers in the table are givenas examples only and should not be considered as recommendations. Methodtransfers should account for the variability and sensitivity of the method andthe specifications for the quality parameter. Alternative procedures andacceptance criteria may be applied based on science and the characteristics ofthe analytical method and the analyte.
下表提供了分析测试可能的实验设计和接受标准的示例。表内的数字只是举例，不应视为建议。方法转移应该考虑方法的可变性和灵敏度以及质量参数的标准。基于科学和分析方法、被分析物的特点，可以采用其他的程序和接受标准。
Test 测试 | Considerations for transfer 转移的考量 | Replication of tests 测试重复次数 | Set-up 设置 | Acceptance criteria Direct 接受标准 | Statistically derived 统计推导 |
Assay for potency 效价分析 | Specific methods where possible should be used 如有可能应使用专属性方法 A bracketing approach may be used for multiple strengths 对于不同规格可使用括号法 | At each site: 每个实验室： 2 analysts × 3 lots, in triplicate (= 18 per site) 2分析师× 3批，重复三次（每个实验室18次） | Different sets of instruments and columns 不同的仪器和柱组合 Independent solution preparation 独立的溶液配制 | Comparison of mean and variability 比较平均值和偏差 | Two one sided t-tests with inter-site differences ≤2% , 95% confidence 双单侧t检验，实验室间差异≤2% @95%置信度 |
Content Uniformity 含量均匀性 | If method is equivalent to assay method, separate transfer is not usually required 如果该方法与含量测定方法等同，则通常不需要分别 转移 | At each site: 每个实验室： 2 analysts, × 1 lot (= 2 per site) 2分析师×1批（=每个实验室2次） | Different sets of instruments and columns 不同的仪器和柱组合 Independent solution preparation 独立的溶液配制 | Mean at RU within ± 3% of mean at SU; 接收方的平均值在转移方平均值的±3%以内 comparison of relative standard deviation 比较相对标准偏差 | Two one sided t-tests with inter-site differences ≤ 3% , 95% confidence 双单侧t检验，实验室间差异≤3% @95%置信度 |
Dissolution 溶出度 | Bracketing may be appropriate for multiple strengths 对于不同规格可使用括号法 | 6 units (12, if not routine at RU, and for extended release products) 6个单位(12个，如接收方不作为常规测试，和延长放行产品) |
| Mean at RU within ± 5% of mean at SU 接收方的平均值在转移方平均值的±5% | Compare profile (e.g. F2), or compare data at Q time points, as for assay 比较资料(如F2)，或比较Q时间点的数据 |
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