Bioequivalence and Bioavailability Forum

kaushalraval ☆ India, 2008-12-27 08:42 (6380 d 06:34 ago) Posting: # 2981 Views: 6,007	Significant effects in bioequivalence [General Statistics] Post reply
	What are the genuine reasons for significant treatment, sequence and period effects? How can we justify significant effects found in bioequivalence study? -- Edit: Category changed. Please see the Forum's Policy also. [Helmut]

Ohlbe ★★★ France, 2008-12-27 19:15 (6379 d 20:01 ago) @ kaushalraval Posting: # 2982 Views: 4,732	Significant effects in bioequivalence Post reply
	Dear Kaushalraval, Have a look at the collection of Helmut's lectures. Regards Ohlbe

kaushalraval ☆ India, 2008-12-30 14:30 (6377 d 00:46 ago) @ Ohlbe Posting: # 2990 Views: 4,691	Significant effects in bioequivalence Post reply
	Thanks for the reply. Kindly tell me in which slide? Kaushal -- Edit: Full quote removed. Please see this post! [Helmut]

Helmut
★★★

Vienna, Austria,
2008-12-30 17:19
(6376 d 21:56 ago)

@ kaushalraval
Posting: # 2992
Views: 4,781

Significant effects in bioequivalence

Post reply

Dear Kaushal!

❝ Kindly tell me in which slide?

In many lectures... The most recent one:
Significant treatment effect (slide 59).
There are two scenarios where you may observe a significant treatment effect:

low variability: the confidence interval dose not include unity (100%) - no problem for any regulatory authority except the Danish one...
confidence interval entirely outside the acceptance range: bioINequivalence demonstrated - reformulate!

Period and sequence effects (slides 97-106).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Significant effects in bioequivalence [General Sta­tis­tics]

Significant effects in bioequivalence

Significant effects in bioequivalence

Significant effects in bioequivalence

Significant effects in bioequivalence [General Statistics]