BA/BE Studies for Early Termination [Two-Stage / GS Designs]

posted by balakotu – India, 2015-09-22 15:05 (3433 d 20:34 ago) – Posting: # 15441
Views: 6,483

Dear all,

We are planning to conduct one "Replicate 4-period" bio-equivalence study with 70 subjects.

After completion of clinical phase we will analyze only 40 subjects.

If 40 subject’s data is shown bio-equivalent then we will stop the analysis of remaining 30 subjects. If the data is predictable then we will analyze remaining 30 subjects.

Please clarify whether this approach/design is acceptable to regulatory are not.

Regards

Kotu


Edit: Category changed. [Helmut]

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