Bioequivalence and Bioavailability Forum

Dear young apprentice of magick!

I would strongly suggest to add a more real world nickname and add it to your signature.

❝ suppose if i conduct two way crossover BA/BE study in 60 subjects, out of this 60 subjects, if 1 subject is considered outlier as per analytical data.

❝ How can we plan redosing study in 10 subjects including anamolus?

According to a presentation given by Barbara Davit (FDA) a couple of years ago a redosing study should include the suspected subject(s) and subjects showing a 'normal' response in the first study. The minimum sample size of the redosing study is six or 20% of the size of the original study, whichever is larger - in your case twelve subjects (not ten).
See also:

AC Braddy, D Patel, AJ Jackson, B Davit, D Conner
Statistical Outliers: The Significance and Impact of Re-dosing Studies to Establish Bioequivalence
AAPS Journal 10(S2) 1564 (2008)
online

❝ If anamolous subject gets the same concentration data as same as previous study, what should be done with study results?

The outlier is confirmed and can't be removed from the original dataset. Bad luck. Since a repeated product failure is unlikely, maybe you have discovered a new subpopulation (= subject-by-formulation interaction). Publish it and become famous.

❝ Or is there any provision for outlier in any guideline?

Only some general statements in the Canadian draft.