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msmnainar ★ India, 2013-01-30 08:20 (4886 d 07:33 ago) Posting: # 9930 Views: 12,470 |
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Hello All Request your advise on the f2 similarity factor calculation, Per below formula f2 = 50*Log{1+1/N[SUM(Rt-Tt)2]}-0.5*100 where, Rt and Tt are the cumulative percentage dissolved at each of the selected n time points of the reference and test product, respectively. Here, my doubt is in place of time, shall we use change in concentration where there is no time specific involvement. Kindly clarify. Thanks Edit: Category changed. Helmut — Sundar. M |
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Helmut ★★★   Vienna, Austria, 2013-02-01 15:30 (4884 d 00:23 ago) @ msmnainar Posting: # 9943 Views: 10,431 |
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Hi Sundar! ❝ Here, my doubt is in place of time, shall we use change in concentration where there is no time specific involvement. Can you please rephrase? As stated in your original post the cumulative percentages dissolved are compared. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2013-02-01 21:39 (4883 d 18:14 ago) @ msmnainar Posting: # 9947 Views: 10,434 |
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Hi Sundar, ❝ f2 = 50*Log{1+1/N[SUM(Rt-Tt)2]}-0.5*100 ❝ ❝ where, Rt and Tt are the cumulative percentage dissolved at each of the selected n time points of the reference and test product, respectively. ❝ ❝ Here, my doubt is in place of time, shall we use change in concentration where there is no time specific involvement. what are you trying to ask? Convert to concentration? Can't you calculate percent dissolved and the compute the cumulative???? John |
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msmnainar ★ India, 2013-02-04 07:21 (4881 d 08:32 ago) @ jag009 Posting: # 9953 Views: 10,115 |
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Dear Both Am having initial and bound phosphate concentration for Test and Reference product, respectively as mentioned below. Kindly guide me can we do f2 calculation using this data, i.e. concentration in place of time. Initial concentration (mM) 1.000 2.500 5.000 10.000 15.000 Bound Phosphate (for Test product) 0.005 3.527 8.559 14.223 18.951 Bound Phosphate (for Reference product) 0.007 3.543 8.318 14.904 18.919 Thanks and Regards, — Sundar. M |
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Oiinkie ☆ The Netherlands, 2013-02-04 18:14 (4880 d 21:39 ago) @ msmnainar Posting: # 9964 Views: 10,156 |
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Dear Sundar, ❝ Am having initial and bound phosphate concentration for Test and Reference product, respectively as mentioned below. Kindly guide me can we do f2 calculation using this data, i.e. concentration in place of time. It seems to me that you are trying to adopt the f2 calculation, which is specifically applied to compare dissolution profiles (concentration vs time data in a dissolution vessel), to a different concept. IMHO, you should find a different test to compare your products. — Regards, Oiinkie |
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msmnainar ★ India, 2013-02-07 09:07 (4878 d 06:46 ago) @ Oiinkie Posting: # 9983 Views: 10,080 |
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Hi Oiinkie, From USFDA-OGD recommendation, for Calcium acetate similarity factor may be applied to compare mean phosphate binding profiles. Whereas, in phosphate binding in-vitro study mean phosphate binding profile will be generated based on the initial phosphate concentration in the solution and not related to the time. Hence, my doubt is whether we can apply f2 test to compare the concentration based mean profile without time involvement. Hope it clears. Regards — Sundar. M |
Ing. Helmut Schütz