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chiragkhatri ★ India, 2009-05-22 15:21 (6244 d 23:30 ago) Posting: # 3727 Views: 6,030 |
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Dear All, In the recent development by FDA on highly variable (HVD) a reference scaling approach has been suggested as mentioned in the paper by Sam H.Haidar. In this of the different approaches method 2 has been found to be acceptbale to FDA. For Reference scaling approach we need partial replicate design where T is given once and R is given twice In this the calculation is done using the formula UT-UR^2 / Sigmawr^2 < theta we have calculated the UT and UR and theta. Sigmawr is the estimated within subject standard deviation (estimated from the ANOVA on the log scale) My question is - Since we have two set of data for R, which data set should be used to calculated Sigmawr. Either of them can be used or we have to take average of both the sets. Pl clarify. Thanks and Regards Chirag Khatri -- Edit: Category changed. [Helmut] |
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Ravi ★ India, 2009-05-23 08:40 (6244 d 06:10 ago) @ chiragkhatri Posting: # 3735 Views: 4,667 |
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Dear Mr. Chirag, ❝ Sigmawr is the estimated within subject standard deviation (estimated from the ANOVA on the log scale) SigmaWR is estimated within subject standard deviation of the Reference product. ❝ My question is - Since we have two set of data for R, which data set should be used to calculated Sigmawr. Either of them can be used or we have to take average of both the sets. Since you have to calculate SigmaWR, According to my Knowledge you have to use both the set of data for R. Otherwise how will you calculate intra subject standard deviation for reference product. If you use both the data set for R only then you can compare the responses (Cmax, AUC etc.) for one subject resulting from administration of reference product (R) at two different periods. Hope this will help. — Thanks & Regards Ravi Pandey |
Ing. Helmut Schütz