fully replicate design with four sequence [RSABE / ABEL]

posted by RK – India, 2013-09-20 15:56 (4662 d 09:19 ago) – Posting: # 11533
Views: 9,580

Hi Helmut,

On reviewing the data of four period two sequence (ABAB and BABA) fully replicated study retrospectively, there is a statistically significant period effect reported for Cmax. So would like to know whether we can use four period four sequence fully replicated study to nullify this period effect which is described in the FDA guideline (Appendix B- Reasons Unrelated to Carryover Effects).

regards
RK

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