Email:[email protected]
7,、給出分析方法轉(zhuǎn)移過程中可能的實驗設(shè)計和接受標(biāo)準(zhǔn):
Test 測試 | Considerations for transfer 轉(zhuǎn)移的考量 | Replication of tests 測試重復(fù)次數(shù) | Set-up 設(shè)置 | Acceptance criteria Direct 接受標(biāo)準(zhǔn) | Statistically derived 統(tǒng)計推導(dǎo) |
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(fù)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(biāo)準(zhǔn)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) |