Bioequivalence and Bioavailability Forum • Period effect

Period effect [Off Topic]

posted by kumarnaidu – Mumbai, India, 2014-01-28 08:54 (4178 d 20:43 ago) – Posting: # 12280
Views: 14,646

Hi all,
If the the drug is highly variable then is it possible that we can get big difference in Cmax and AUC in two period for both test and reference. In one of pilot study I got the results below.

Test Cmax: Period 1 and period 2: 951 and 189 (approx)
Test AUC: Period 1 and period 2: 1700 and 225 (approx)

Reference Cmax: Period 1 and period 2: 830 and 276 (approx)
Reference AUC: Period 1 and period 2: 1500 and 360 (approx)

Edit: Subject line changed. [Helmut]

—
Kumar Naidu

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 effectkumarnaidu 2014-01-28 07:54
        
        Period effect Dr_Dan 2014-01-28 10:36
        
        Period effect kumarnaidu 2014-01-28 11:51
        
        Period effect Helmut 2014-01-28 13:48
        
        Period effect kumarnaidu 2014-01-29 04:49