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MGR ★ India, 2007-01-03 06:39 (6702 d 09:39 ago) Posting: # 429 Views: 8,622 |
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Hi to all, As we are dealing with a steady state study, can any one guide me how to perform the statistical analysis, the parameters calculated (AUC0-tau, %PTF)or are there any other parameters to be calculated for steady state study. If there are any sites or information regarding steady state statistical analysis. Kindly let me know. And also please tell me the which procedure (ANOVA- Linear Model) and tests to be used for statistical analysis using SAS software. Thanks and regards, MGR — Regards, MGR |
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H_Rotter ★ Germany, 2007-01-04 17:05 (6700 d 23:12 ago) @ MGR Posting: # 433 Views: 6,893 |
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Hi MGR! Have a look at Helmut's post. Especially for drugs with low accumulation, BE for Cmin may be very difficult to demonstrate; if ever possible (safety/efficacy) you may try to apply a wider acceptance range for this parameter (but keep an eye on recent developments, which may prevent this...). ❝ And also please tell me the which procedure(ANOVA- Linear Model) and tests to be used for statistical analysis using SAS software. I think we had this already. Regards, Hermann |
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Imran ☆ Mumbai, 2007-01-10 10:52 (6695 d 05:26 ago) @ MGR Posting: # 449 Views: 7,160 |
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Dear MGR For SS study u need to estimate Cmin, Cmax, AUC0-tau, PTF. These parameters can be calulated by any PK software such as WinNonlin or SAS. SS achived can be proved statistically by regression analysis. For more information u can refer USFDA guidance or CPMP guidlines for Extended release product. I hope ur querry is answere to some extent regards Dr.Imran Khan — Dr.Imran Khan |
Ing. Helmut Schütz