Acarbose Study Design for US filing [Regulatives / Guidelines]

posted by hiren379 – India, 2011-07-30 19:11 (5446 d 18:24 ago) – Posting: # 7242
Views: 1,894

Hi all,
Can u please tell me how to design pilot study for Acarbose for US. OGD`s recommendation is fine, but I have some doubts

1) Whether pilot study will be parallel or crossover
2) How to assess the optimum dose for Pivotal study
3) Statistics to be applied
3) Also please explain me the design briefly

Thanks

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