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jag009 ★★★ NJ, 2012-06-07 00:18 (5132 d 15:29 ago) Posting: # 8669 Views: 5,293 |
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Hi all, For a FDA 3-way BE studies (I know, it's strange), does it matter if I use 3 or 6 sequence? I plan to go with 3 sequence because I don't want to see a case where 1 sequence ends up with only 1 or 2 subjects due to dropouts whiles other sequence have more. ie: 24 subjects, 6 sequence, what if I happen to lose 4-5 subjects in sequence #4 (Hey people win a lottery sometime) I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required. Thanks John |
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Helmut ★★★   Vienna, Austria, 2012-06-07 15:48 (5132 d 00:00 ago) @ jag009 Posting: # 8670 Views: 4,635 |
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Hi John! ❝ For a FDA 3-way BE studies (I know, it's strange), does it matter if I use 3 or 6 sequence? We had an exhaustive discussion previously. Seems that EMA prefers a 6×3 Williams’ design; FDA no idea. ❝ I plan to go with 3 sequence because I don't want to see a case where 1 sequence ends up with only 1 or 2 subjects due to dropouts […] (Hey people win a lottery sometime) Hey some people wear their trousers with belts + suspenders.  ❝ I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required. Can’t remember.  — 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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drgunasakaran1 ★★  2012-06-07 19:48 (5131 d 19:59 ago) @ jag009 Posting: # 8677 Views: 4,559 |
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Dear Mr John, ❝ I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required. As per Old FDA's BE Guidance on Single dose, three way cross over, food/fasting study, six sequences should be used. Quote from the Old FDA’s BE guidance “A single dose, randomized, three-treatment, three period, six sequence, crossover, limited food effects study, comparing equal doses of the test product administered under fasting conditions with those of test and reference products administered immediately after a standard breakfast”. (Refer page 3 of the Old FDA's BE Guidance) “Equal number of subjects should be randomly assigned to each of the six dosing sequences” (Refer page 10 of Old FDA's BE Guidance) — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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jag009 ★★★ NJ, 2012-06-07 22:02 (5131 d 17:45 ago) @ drgunasakaran1 Posting: # 8679 Views: 4,428 |
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Thanks drgunasakaran1. But what if I end up losing all my subjects from 1 of the 6 sequence? I know it's highly unlikely... John |
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d_labes ★★★ Berlin, Germany, 2012-06-08 10:49 (5131 d 04:58 ago) @ jag009 Posting: # 8680 Views: 4,441 |
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Dear John, ❝ But what if I end up losing all my subjects from 1 of the 6 sequence? I know it's highly unlikely... Nothing serious happens even in that highly unlikely case  .The study stays evaluable. The only thing you loose is that the design is no longer a design with minimum variance. I.e. the confidence intervals a somewhat broader compared to a balanced design with the same number of subjects (if this exists). Just to cite our Ol' pirate and captain ElMaestro  :"Imbalance, as I see it, no doubt plays a role - sometimes even an obscure one ..." — Regards, Detlew |
Ing. Helmut Schütz