jag009 Hero NJ, 20180410 15:58 Posting: # 18662 Views: 1,680 

Hi, A question... If two products achieve release ≫85% at the 2nd timepoint, do i still need to calculate f2 since f2 requires a minimum of 3 points and only 1 value above 85% can be included? Please see below, at 2nd timepoint it's already ≫85%. I know that f2 is not required if release >85% within 15 mins but the lab only recorded release at 20 mins. It's safe to assume that >85% was probably achieved by 15 mins but i have no data to support. Test at 10 mins=42%, at 20 mins=92%, at 30 mins=97% RLD at 10 mins=43%, at 20 mins=92%, at 30 mins=98% Thanks J 
wienui Regular Germany, Oman, 20180410 17:39 (edited by wienui on 20180411 06:11) @ jag009 Posting: # 18663 Views: 1,469 

Hi John, Yes you need to calculate the f2 (as you cann't prove the release at 15 min was ≥ 85%.) for the above given 3 dissolution time points and don't include anymore time points. What about the CV% or RSD% for the 10min and the other time points? otherwise bootstrapping is recommended. Best regards, Osama Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] 
Vineeth KE Junior India, 20180412 08:31 @ jag009 Posting: # 18667 Views: 1,335 

Dear Jag009, ≫85% at the 2nd timepoint, do i still need to calculate f2 No need to calculate f2 value » Please see below, at 2nd timepoint it's already ≫85%. I know that f2 is not required if release >85% within 15 mins but the lab only recorded release at 20 mins. It's safe to assume that >85% was probably achieved by 15 mins but i have no data to support. It is not always mandatory to follow the particular time points such as (5, 10, 15, 20 ....etc) and moreover the time points are depends upon the release characteristics of the dosage form. If the product dissolution is evaluating for the BCS Based biowaiver, it is better to prove Rapid/very rapid dissolution by including time points such as 15 or 30 min. As per USFDA guidance on BCS based Biowaiver Dec 17, BCS Biowaiver USFDA Dec 2017 when both test and reference products dissolve 85 percent or more of the label amount of the drug in 15 minutes using all three dissolution media recommended above, the profile comparison with an f2 test is unnecessary. Thank you. 
wienui Regular Germany, Oman, 20180412 10:14 @ Vineeth KE Posting: # 18668 Views: 1,310 

Dear Vineeth KE, » It is not always mandatory to follow the particular time points such as (5, 10, 15, 20 ....etc) and moreover the time points are depends upon the release characteristics of the dosage form. This is correct » when both test and reference products dissolve 85 percent or more of the label amount of the drug in 15 minutes using all three dissolution media recommended above, the profile comparison with an f2 test is unnecessary. This is also correct, but from the above given data, release % at time point 15min. was not given, There is no evidence that 85% release at 15min, it could be and it couldn't be ( as Example, it could be only release of 64%, 76%, 82%). Therefore, a calculation of F2 is needed. Best regards, Osama 
Yura Regular Belarus, 20180412 14:13 @ wienui Posting: # 18669 Views: 1,243 

Dear wienui The calculation of f2 is also not possible, since the point of more than 85% of the solution must be 1 (i.e. already at the second point, at 20 minutes), and for calculation there have to be not less than three points. Changing the laboratory will revive the process or to use other methods of assessment. Best regards 
wienui Regular Germany, Oman, 20180412 17:38 @ Yura Posting: # 18672 Views: 1,270 

Dear Yura, » The calculation of f2 is also not possible, Sorry, I don't get your point, Why it is not possible to calculate the f2 using the above 3 time points? since the point of more than 85% of the solution must be 1 I think you mean, acc. to the GL's not more than 1 time point is allowed to be added in the calculation of f2 after reaching the 85% releasing time point ( 20 min.), which is here already done. and for calculation there have to be not less than three points. They are 3 releasing time points ( 10min, 20min & 30min.) Changing the laboratory will revive the process or to use other methods of assessment. Why changing the Lab.?? only calculation the f2 as normal is needed Best regards Osama 
Yura Regular Belarus, 20180413 07:48 @ wienui Posting: # 18677 Views: 1,012 

Dear wienui The laboratory can't take adequate temporary points? for example, 510152030 Best regards 
jag009 Hero NJ, 20180412 17:10 @ jag009 Posting: # 18671 Views: 1,232 

Thank you. John 