Comparing methods for (S)ABE [RSABE / ABEL]

posted by pjs – India, 2018-03-05 14:50 (1573 d 00:41 ago) – Posting: # 18496
Views: 8,674

Hi Helmut,

Thanks for your feedback.

Yes agree with you, harmonization should be there for evaluating BE criteria incase of HVDP or NTI drugs or any such evaluation criteria.

Have gone through some of the post related to alpha correction incase of SABE approach in the forum. In the simulations done most extreme GMR of 1.25 is assumed for the simulation and calculation of possible alpha inflation.

I would like to understand as the actual alpha adjustment would be based on actual Swr observed in the study and number of subjects, what could be the rationale of doing adjustment of alpha based on the calculation which is done on extreme GMR while for the actual study conducted T/R ratio could be very much close to unity (let's say 0.95 or 0.97). I do understand the most deviated GMR would lead to maximum probability for the alpha inflation but applying this extreme case and alpha adjustment in each and every study is required?


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