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Priyanka_S ☆ 2010-06-24 13:13 (5476 d 19:42 ago) Posting: # 5556 Views: 4,771 |
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Dear HS, We are planning to go replicated design with two stage sequential approach. Is this procedure acceptable for replicated designs for European submission? In replicated designs we are not considering Subject(sequence) effect as random effect. Kindly suggest me the fixed and random effects for this replicated design with two stage sequential approach. Edit: Category changed. [Helmut] — Best Regards Priyanka S |
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Helmut ★★★   Vienna, Austria, 2010-06-24 14:45 (5476 d 18:10 ago) @ Priyanka_S Posting: # 5557 Views: 3,911 |
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❝ Dear HS, ^^ ... and the other members of the forum!❝ We are planning to go replicated design with two stage sequential approach. Hhm - to my knowledge there's no such a method published right now. Agree that it would be desirable to have such a method. ❝ Is this procedure acceptable for replicated designs for European submission? No idea. ❝ In replicated designs we are not considering Subject(sequence) effect as random effect. Doubtful, IMHO. ❝ Kindly suggest me the fixed and random effects for this replicated design with two stage sequential approach. Again, no idea. Sorry. — 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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d_labes ★★★ Berlin, Germany, 2010-06-24 16:51 (5476 d 16:05 ago) @ Helmut Posting: # 5558 Views: 3,849 |
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Dear Helmut, dear Priyanka, ❝ ❝ We are planning to go replicated design with two stage sequential approach. ❝ ❝ Hhm - to my knowledge there's no such a method published right now. Agree that it would be desirable to have such a method. Have a look into Patterson et. al. "Non-traditional study designs to demonstrate average bioequivalence for highly variable drug products" European Journal of Clinical Pharmacology Volume 57, Number 9 / November 2001, 663-670 There is on page 666 a study mentioned which was done as two-stage sequential with a replicate cross-over design. As far as I can see from the very short description the 95% CIs were used as decision criterion at the two stages (classical Bonferroni alpha spending). No model mentioned which incorporates the stages, mainly because the study didn't need a second stage. No hint if overall alpha=0.05 is preserved by this method. Unfortunately I was not able to locate the mentioned original paper  cited in that paper as Patterson (2000), "Approaches to meeting a nearly impossible regulatory hurdle: demonstrating average bioequivalence for a highly variable drug product" Clin. Pharmacol. Ther. 67: 115 to get more insight. ---------------- [edit] -----------------------; Solved: Its an abstract of a speech or poster. ---------------- [/edit] ----------------------; BTW: I would never consider or plan a study with a design I'm not able to evaluate, whatever advantages this design else had! But may be others have more foolhardy guts. — Regards, Detlew |
Ing. Helmut Schütz