Tel：153 2100 2012
Email：[email protected]
Beijing Four Sentences of Heng Qu science and technology Co., Ltd.
北京橫渠四句科技有限公司
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WHO發(fā)布《制藥生產(chǎn)技術(shù)轉(zhuǎn)移指南》,！
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作者:4SHQ
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發(fā)布時間: 331天前
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*Note: These are examples. All therequired documents should be identified for the different tasks. 注意:以上為示例。針對不同的任務(wù),，應(yīng)該識別出所有需要的文件,。 Appendix 2 Exampleof possible experimental designs and acceptance criteria for analytical testing 附錄2. 分析測試可能的實驗設(shè)計和接受標準示例 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. 下表提供了分析測試可能的實驗設(shè)計和接受標準的示例,。表內(nèi)的數(shù)字只是舉例，不應(yīng)視為建議,。方法轉(zhuǎn)移應(yīng)該考慮方法的可變性和靈敏度以及質(zhì)量參數(shù)的標準,。基于科學和分析方法,、被分析物的特點,，可以采用其他的程序和接受標準。 Test 測試 Considerations for transfer 轉(zhuǎn)移的考量 Replication of tests 測試重復次數(shù) Set-up 設(shè)置 Acceptance criteria Direct 接受標準 Statistically derived 統(tǒng)計推導 Assay for potency 效價分析 Specific methods where possible should be used 如有可能應(yīng)使用專屬性方法 A bracketing approach may be used for multiple strengths 對于不同規(guī)格可使用括號法 At each site: 每個實驗室： 2 analysts × 3 lots, in triplicate (= 18 per site) 2分析師× 3批,，重復三次（每個實驗室18次） Different sets of instruments and columns 不同的儀器和柱組合 Independent solution preparation 獨立的溶液配制 Comparison of mean and variability 比較平均值和偏差 Two one sided t-tests with inter-site differences ≤2% , 95% confidence 雙單側(cè)t檢驗,，實驗室間差異≤2% @95%置信度 Content Uniformity 含量均勻性 If method is equivalent to assay method, separate transfer is not usually required 如果該方法與含量測定方法等同，則通常不需要分別 轉(zhuǎn)移 At each site: 每個實驗室： 2 analysts, × 1 lot (= 2 per site) 2分析師×1批（=每個實驗室2次） Different sets of instruments and columns 不同的儀器和柱組合 Independent solution preparation 獨立的溶液配制 Mean at RU within ± 3% of mean at SU; 接收方的平均值在轉(zhuǎn)移方平均值的±3%以內(nèi) comparison of relative standard deviation 比較相對標準偏差 Two one sided t-tests with inter-site differences ≤ 3% , 95% confidence 雙單側(cè)t檢驗,，實驗室間差異≤3% @95%置信度 Dissolution 溶出度 Bracketing may be appropriate for multiple strengths 對于不同規(guī)格可使用括號法 6 units (12, if not routine at RU, and for extended release products) 6個單位(12個,，如接收方不作為常規(guī)測試，和延長放行產(chǎn)品) Mean at RU within ± 5% of mean at SU 接收方的平均值在轉(zhuǎn)移方平均值的±5% Compare profile (e.g. F2), or compare data at Q time points, as for assay 比較資料(如F2),，或比較Q時間點的數(shù)據(jù)
北京橫渠四句科技有限公司
Beijing Four Sentences of Heng Qu science and technology Co., Ltd.
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