Critical value [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2011-06-29 11:07 (5474 d 09:00 ago) – Posting: # 7182
Views: 6,435

Dear Ankita,

the answer to your question can be found in the references you gave (especially http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/ucm070118.pdf page 7).
An example of the sentence "People able to read are clearly in advantage in reading" :cool:.

What the SAS code excerpt you cite does is the calculation of the critical value (V as a function of the two group variances and their degrees of freedom) and with that the confidence interval for the difference
     (µTR)
the very first term in the population BE criterion.

The test used for that end is a variant of a test for comparing two means without the assumption of equal variances.
This is commonly termed Behrens-Fisher problem.

The more commonly known (approximate) solution to the Behrens-Fisher problem is the Welch t-test.
Search the forum for that.

The guidance suggest to use the Lee-Gurland1,2,3 variant instead of the Welch test because this is said to have better performance with small sample sizes.

1Lee A.F.S., J. Gurland
"Size and power of test for equality of means of two normal populations with unequal variances"
J Amer Statist Assoc, 70, 933-941 (1975)

2Lee A.F.S., N.S. Fineberg
"A fitted test for the Behrens-Fisher problem"
Comm Statist- Theory Meth, 20, 653-666 (1991)

3Lee A.F.S.
"Coefficients of lee-gurland two-sample test on normal means"
Comm Statist- Theory Meth, 24, 1743-1768 (1995)

Astonishing enough I havn't found any software which delivers the Lee-Gurland test out of the box, even not in R. :ponder:

Regards,

Detlew

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
136 visitors (0 registered, 136 guests [including 27 identified bots]).
Forum time: 20:08 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5