Bioequivalence and Bioavailability Forum

udayk ☆ India, 2013-06-21 11:35 (4748 d 11:16 ago) Posting: # 10846 Views: 5,494	Hypothesis in Bioequivalence Studies [General Statistics] Post reply
	Dear Members, Thanks to the forum for accepting me as a member and the registration process was indeed very quick. here my query is, What is the null and alternative hypothesis in bioequivalence studies. Can anyone help. With Regards Uday Bio-Statistician Edit: Category changed. [Helmut]

Helmut
★★★

Vienna, Austria,
2013-06-21 15:51
(4748 d 07:00 ago)

@ udayk
Posting: # 10851
Views: 4,716

Hypotheses in Bioequivalence Studies

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Hi Uday,

welcome to the club!

❝ What is the null and alternative hypothesis in bioequivalence studies.

Please search the forum first. Or :google:

click here…

The Null hypothesis is bioinequivalence; generally based on the 1–2α confidence interval of the ratio of log-transformed adjusted (aka least squares) means compared to the acceptance range (AR). Therefore:

CI ⊂ AR: H₀ rejected, H_a of BE accepted.*
CI not entirely within the AR, but CL_lo < AR_hi ∩ CL_hi > AR_lo: indecisive
(e.g., CV higher and/or T/R more deviant from 1 than expected; more dropouts than anticipated).
CI ⊄ AR (CL_hi < AR_lo ∨ CL_lo > AR_hi): H₀ accepted, bioinequivalence proven.

If you prefer this notation:\begin{matrix}
H_0:\mu_T/\mu_R < \theta_1 \vee \mu_T/\mu_R > \theta_2 \\
H_a:\theta_1\leq\mu_T/\mu_R\leq\theta_2
\end{matrix} where \(\theta_1\) and \(\theta_2\) are the lower and upper boundaries of AR based on a clinically not relevant difference \(\Delta\). With the common \(\Delta\) of 20% you get \(\theta_1=1-\Delta=0.8\) and \(\theta_2=(1-\Delta)^{-1}=1.25\).

In the special case that the CI does not contain 1 formulations are statistically different (p <α), but this difference is considered clinically not relevant (e.g., CV lower and/or T/R less deviant from 1 than expected, fewer dropouts than anticipated, for drugs with low CV high power due to the regulatory minimum sample size). For an example see here.

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ElMaestro
★★★

Denmark,
2013-06-21 16:20
(4748 d 06:32 ago)

@ Helmut
Posting: # 10852
Views: 4,605

Management's null hypothesis

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Hi Hötzi,

among the companies that work with OIPs I think there is often also a management's null hypothesis:
We can not submit and expect success if our confidence interval is 47%-128%, and we can not claim widening of acceptance limits even though we did not apply a replicate or semi-replicate design.

When such a hypothesis is applied management strongly believes that the appropriate experiement for refuting the management's null hypothesis is called a de-centralised procedure.

I am not sure if the "null" in those cases refers to some CEO's IQ (blazer, tie, spreadsheet, personal assistant who is a lean manager; both genuinely unpleasant).
Gehtgaaaarnüsch.

Have a great weekend.

—
Pass or fail!
ElMaestro

Hypothesis in Bioequivalence Studies [General Sta­tis­tics]

Hypotheses in Bioequivalence Studies

Management's null hypothesis

Hypothesis in Bioequivalence Studies [General Statistics]