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(shí)間: 389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(duì)不同的任務(wù),，應(yīng)該識(shí)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(cè)試可能的實(shí)驗(yàn)設(shè)計(jì)和接受標(biāo)準(zhǔn)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(cè)試可能的實(shí)驗(yàn)設(shè)計(jì)和接受標(biāo)準(zhǔn)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(biāo)準(zhǔn)?；诳茖W(xué)和分析方法,、被分析物的特點(diǎn)，可以采用其他的程序和接受標(biāo)準(zhǔn),。 Test 測(cè)試 Considerations for transfer 轉(zhuǎn)移的考量 Replication of tests 測(cè)試重復(fù)次數(shù) Set-up 設(shè)置 Acceptance criteria Direct 接受標(biāo)準(zhǔn) Statistically derived 統(tǒng)計(jì)推導(dǎo) Assay for potency 效價(jià)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(duì)于不同規(guī)格可使用括號(hào)法 At each site: 每個(gè)實(shí)驗(yàn)室： 2 analysts × 3 lots, in triplicate (= 18 per site) 2分析師× 3批,，重復(fù)三次（每個(gè)實(shí)驗(yàn)室18次） Different sets of instruments and columns 不同的儀器和柱組合 Independent solution preparation 獨(dú)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(yàn)，實(shí)驗(yàn)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(cè)定方法等同,，則通常不需要分別 轉(zhuǎn)移 At each site: 每個(gè)實(shí)驗(yàn)室： 2 analysts, × 1 lot (= 2 per site) 2分析師×1批（=每個(gè)實(shí)驗(yàn)室2次） Different sets of instruments and columns 不同的儀器和柱組合 Independent solution preparation 獨(dú)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(duì)標(biāo)準(zhǔn)偏差 Two one sided t-tests with inter-site differences ≤ 3% , 95% confidence 雙單側(cè)t檢驗(yàn),，實(shí)驗(yàn)室間差異≤3% @95%置信度 Dissolution 溶出度 Bracketing may be appropriate for multiple strengths 對(duì)于不同規(guī)格可使用括號(hào)法 6 units (12, if not routine at RU, and for extended release products) 6個(gè)單位(12個(gè),，如接收方不作為常規(guī)測(cè)試，和延長(zhǎng)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(shí)間點(diǎn)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.
電話：153 2100 2012
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