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Mithu ★ India, 2022-07-25 08:39 (860 d 14:06 ago) Posting: # 23165 Views: 3,630 |
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Dear All, Is it advisable to have little large sample size for molecules falls under BCS Class II and IV? especially when routine 2WC design is selected? Regards, Mithu Edit: Category changed; see also this post #1. [Helmut] |
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dshah ★★ India, 2022-07-25 11:44 (860 d 11:00 ago) @ Mithu Posting: # 23166 Views: 3,020 |
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Dear Mithu! It's mainly based on your estimated T/R ratio, ISCV, desired Power. Regards, Divyen |
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Mithu ★ India, 2022-07-25 12:56 (860 d 09:48 ago) @ dshah Posting: # 23170 Views: 2,959 |
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❝ Dear Mithu! ❝ It's mainly based on your estimated T/R ratio, ISCV, desired Power. regards, Mithu |
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Helmut ★★★   Vienna, Austria, 2022-07-25 11:56 (860 d 10:49 ago) @ Mithu Posting: # 23167 Views: 3,012 |
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Hi Mithu, ❝ Is it advisable to have little large sample size … Larger than what? ❝ … for molecules falls under BCS Class II and IV? especially when routine 2WC design is selected? Only in a few cases of BCS class II drugs (under certain conditions) there is an in vivo in vitro correlation. For BCS class IV drugs never. You plan the study always based on the in vivo variability and T/R-ratio for a desired power. In other words, BCS does not play any role. — 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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Mithu ★ India, 2022-07-25 12:54 (860 d 09:51 ago) @ Helmut Posting: # 23169 Views: 2,960 |
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❝ Larger than what? Larger then needed from expected variability. if observed variability gives samples size around 48 than can we take more than that i.e. around 60. ❝ Only in a few cases of BCS class II drugs (under certain conditions) there is an in vivo in vitro correlation. For BCS class IV drugs never. You plan the study always based on the in vivo variability and T/R-ratio for a desired power. In other words, BCS does not play any role. Here the case is, we are dealing with some technology transfer products in which we could not change our test formulation which was meet the BE marginally at the time of initially filing. now due to this bottle neck, our thinking is if we take little large sample size, than we can manage variability (my expectation may be not correct). Hope I could place my point correctly. Regards, Mithu 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] |
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dshah ★★ India, 2022-07-25 13:19 (860 d 09:25 ago) @ Mithu Posting: # 23171 Views: 3,000 |
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Hi Mithu! ❝ Here the case is, we are dealing with some technology transfer products in which we could not change our test formulation which was meet the BE marginally at the time of initially filing. now due to this bottle neck, our thinking is if we take little large sample size, than we can manage variability (my expectation may be not correct). As per regulatory acceptance- it is either acceptable or unacceptable. So is not best to describe it as marginally acceptable. The in vitro assessment with recent batches of reference is important and also performing a comparative dissolution with older lot (if still available) can be useful. Taking only larger size without consideration of in vitro assessment will not solve your problem. Regards, Divyen Shah |
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Mithu ★ India, 2022-07-25 15:26 (860 d 07:19 ago) @ dshah Posting: # 23175 Views: 2,970 |
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❝ As per regulatory acceptance- it is either acceptable or unacceptable. So is not best to describe it as marginally acceptable. Just to make it clear that I am trying to say that study is passing at 80.5% lower CI. ❝ The in vitro assessment with recent batches of reference is important and also performing a comparative dissolution with older lot (if still available) can be useful. ❝ ❝ Taking only larger size without consideration of in vitro assessment will not solve your problem. Thank you. Regards, |
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Helmut ★★★ Vienna, Austria, 2022-07-25 15:02 (860 d 07:42 ago) @ Mithu Posting: # 23173 Views: 2,923 |
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Hi Mithu, ❝ ❝ Larger than what? ❝ Larger then needed from expected variability. if observed variability gives samples size around 48 than can we take more than that i.e. around 60. Apart from Divyen’s comments above, make yourself familiar with the basics of sample size estimation, especially the section dealing with assumptions. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Mithu ★ India, 2022-07-25 15:24 (860 d 07:21 ago) @ Helmut Posting: # 23174 Views: 2,947 |
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❝ […] make yourself familiar with the basics of sample size estimation, especially the section dealing with assumptions. Okay. I will do that. thank you for your reply. regards, 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] |
Ing. Helmut Schütz