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Ravi ★ India, 2010-08-10 11:22 (5803 d 08:56 ago) Posting: # 5751 Views: 4,664 |
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Dear All, I want some clearity about "Draft Guidance on Sevelamer Carbonate" (link provided for reference) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm089620.pdf My question is related to section 1 i.e. In-vitro equilibrium binding. In this section it is mentioned that 90% CI should be calulated for k2 with the acceptance criteria of 80% to 125%. Please provide some more clarity about the above highlightened line. 90% CI should be calculated form what - Mean, Geo. Mean or for T/R ratio I just wanted to know how this calculation is to be performed. Reference for the calulation for k1 and k2 can be found from this link http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TGX-45BCTJG-1&_user=6968900&_coverDate=06%2F20%2F2002&am...;_ct=1635&_acct=C000067714&_version=1&_urlVersion=0&_userid=6968900&md5=55836e6b72e078246382082891985e26 — Thanks & Regards Ravi Pandey |
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govardhanpillari ☆ India, 2010-09-04 11:08 (5778 d 09:10 ago) @ Ravi Posting: # 5886 Views: 2,804 |
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Dear Ravi, ❝ In this section it is mentioned that 90% CI should be calulated for k2 with ❝ the acceptance criteria of 80% to 125%. First of all, the guidance says that 90% CI should be calulated for k2 with the acceptance criteria of 80% to 120%. not the 80% to 125%. ❝ 90% CI should be calculated form what - Mean, Geo. Mean or for T/R ratio ❝ I just wanted to know how this calculation is to be performed. The 90% confidence intervals will be constructed for the ratio of the mean of capacity constant (K2) Regards, PGR Edit: Standard quotes restored. [Helmut] — Govardhan.P |
Ing. Helmut Schütz