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Achievwin ★★ US, 2024-05-03 15:28 (217 d 22:33 ago) Posting: # 23975 Views: 4,019 |
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Dear All: I came across a parallel BE study protocol that has around 900 subjects, has anyone seen BE study of this magnitude for a BE study in patients? Kindly share your experience Achievwin |
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Helmut ★★★   Vienna, Austria, 2024-05-03 15:34 (217 d 22:28 ago) @ Achievwin Posting: # 23976 Views: 3,414 |
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Hi Achievwin, ❝ I came across a parallel BE study protocol that has around 900 subjects, has anyone seen BE study of this magnitude for a BE study in patients? Define magnitude.  If you mean hundreds, yes. Multi-center in patients.BTW, I have seen 4-period full replicate studies with 180 healthy volunteers… — 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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Achievwin ★★ US, 2024-05-03 15:49 (217 d 22:13 ago) @ Helmut Posting: # 23978 Views: 3,382 |
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❝ Define magnitude. ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers… wow for a full replicate N=400 the sponsor has deep pockets… Thanks for your response |
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Helmut ★★★ Vienna, Austria, 2024-05-03 16:19 (217 d 21:42 ago) @ Achievwin Posting: # 23980 Views: 3,464 |
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Hi Achievwin, ❝ ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers… ❝ wow for a full replicate N=400 the sponsor has deep pockets…
— 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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nobody nothing 2024-05-03 20:44 (217 d 17:17 ago) @ Helmut Posting: # 23982 Views: 3,373 |
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❝ Define magnitude. ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers… Photos or it didn't happen. At least intraind CV  — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2024-05-04 00:25 (217 d 13:36 ago) @ nobody Posting: # 23983 Views: 3,371 |
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Hi nobody, ❝ ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers… ❝ ❝ Photos or it didn't happen. At least intraind CV Incidentally I know the backstory of #1 of the post above. It was very difficult to develop a new formulation. Pilot studies (plural!) with 80 subjects. No reference-scaling; however, CV was not the main problem. Sample size based on a best-guess T/R-ratio of 0.85. Do the maths. — 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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Achievwin ★★ US, 2024-05-06 17:56 (214 d 20:06 ago) @ Helmut Posting: # 23990 Views: 3,268 |
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❝ ❝ ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers… High sample size is because it is an NTID and they have to document an additional parameter based on the variance ratios.... In my previous life we did two 3-period replicate design, satisfied guidance on the day we were supposed to submit the ANDA revised guidance was published brought the whole story to the start.  |
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mittyri ★★ Russia, 2024-05-07 09:35 (214 d 04:27 ago) @ Achievwin Posting: # 23991 Views: 3,170 |
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Hi Achievwin, ❝ High sample size is because it is an NTID and they have to document an additional parameter based on the variance ratios.... This is HVNTID! A must read thread about Dabigatran, this study and Originator's hard life — Kind regards, Mittyri |
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dshah ★★ India, 2024-05-08 18:11 (212 d 19:51 ago) @ Helmut Posting: # 23992 Views: 3,089 |
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Hi Helmut! According to me, there is clear requirement to improve T/R ratio from 0.85 to at least 0.9 which can reduce the sample size as well. Regards, Divyen |
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Helmut ★★★ Vienna, Austria, 2024-05-08 18:18 (212 d 19:44 ago) @ dshah Posting: # 23993 Views: 3,098 |
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Hi Divyen, ❝ According to me, there is clear requirement to improve T/R ratio from 0.85 to at least 0.9 which can reduce the sample size as well. — 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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Achievwin ★★ US, 2024-05-17 15:45 (203 d 22:17 ago) @ dshah Posting: # 24000 Views: 2,618 |
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❝ there is clear requirement to improve T/R ratio from 0.85 to at least 0.9 - that is commonsense if you ask a BE guy..... then formulators show 100s for documents that the formulations compare "Spot on" then starts navigation through muddy waters. |
Ing. Helmut Schütz