Bioequivalence and Bioavailability Forum • Period effect

Period effect [Off Topic]

posted by Helmut – Vienna, Austria, 2014-01-28 14:48 (4171 d 20:57 ago) – Posting: # 12283
Views: 14,727

Hi Kumar & Dan,

although it is interesting that you got only ~20–25% of period 1 in period 2, the behavior is consistent for both formulations and both PK metrics. The ratios are pretty close to 100%.

❝ This was a oral suspension.

So it might be worthwhile to look for an explanation (were the suspensions in both periods prepared in exactly the same way and by the same personnel?). However, the BE assessment and – since this is a pilot study – the estimated PEs and CVs are not affected. The period effect means out in a cross-over study.

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Complete thread:

effectiveness of highly variable drugs Ken Peh 2013-12-17 03:45
- HVDs/HVDPs = safe drugs Helmut 2013-12-17 15:11
  - HVDs/HVDPs = safe drugs varun9461 2019-02-22 12:23
- effectiveness of highly variable drugs Dr_Dan 2013-12-18 09:34
  - effectiveness of highly variable drugs Ohlbe 2013-12-18 10:07
    - effectiveness of highly variable drugs Ken Peh 2013-12-20 14:38
      - Period effect kumarnaidu 2014-01-28 07:54
        
        Period effect Dr_Dan 2014-01-28 10:36
        
        Period effect kumarnaidu 2014-01-28 11:51
        
        Period effectHelmut 2014-01-28 13:48
        
        Period effect kumarnaidu 2014-01-29 04:49