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jag009 ★★★ NJ, 2018-04-10 17:58 (2566 d 11:29 ago) Posting: # 18662 Views: 6,456 |
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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 |
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wienui ★ Germany/Oman, 2018-04-10 19:39 (2566 d 09:47 ago) (edited on 2018-04-11 06:11) @ jag009 Posting: # 18663 Views: 5,511 |
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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] — Cheers, Osama |
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Vineeth KE ☆ India, 2018-04-12 10:31 (2564 d 18:55 ago) @ jag009 Posting: # 18667 Views: 5,529 |
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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 bio-waiver, 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 Bio-waiver 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. |
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wienui ★ Germany/Oman, 2018-04-12 12:14 (2564 d 17:12 ago) @ Vineeth KE Posting: # 18668 Views: 5,606 |
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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 — Cheers, Osama |
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Yura ★ Belarus, 2018-04-12 16:13 (2564 d 13:13 ago) @ wienui Posting: # 18669 Views: 5,312 |
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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 |
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wienui ★ Germany/Oman, 2018-04-12 19:38 (2564 d 09:48 ago) @ Yura Posting: # 18672 Views: 5,396 |
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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 — Cheers, Osama |
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Yura ★ Belarus, 2018-04-13 09:48 (2563 d 19:38 ago) @ wienui Posting: # 18677 Views: 5,102 |
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Dear wienui The laboratory can't take adequate temporary points? for example, 5-10-15-20-30 Best regards |
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jag009 ★★★ NJ, 2018-04-12 19:10 (2564 d 10:17 ago) @ jag009 Posting: # 18671 Views: 5,395 |
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Thank you. John |
Ing. Helmut Schütz