Bioequivalence and Bioavailability Forum • Change in curve changed the ratio of Cmax

Change in curve changed the ratio of Cmax [Bioanalytics]

posted by Ohlbe – France, 2015-03-23 15:13 (4116 d 02:11 ago) – Posting: # 14599
Views: 14,211

Dear Compliance,

❝ We had run one 4 Way crossover study with 1-800 ng/ml and we get the ratio of Cmax 102%. We have revised the range 0.250- 250 ng/ml. we repeated the same samples which are initially run with 1-800 ng/ml.

Was there any change in the method apart from the LLOQ ?

Did you run ISR with both methods ? What was the outcome ?

—
Regards
Ohlbe

Complete thread:

Change in curve changed the ratio of Cmax Compliance 2015-03-23 07:39
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-23 08:59
  - Change in curve changed the ratio of Cmax Compliance 2015-03-23 09:27
- Change in curve changed the ratio of Cmax nobody 2015-03-23 09:19
  - Change in curve changed the ratio of Cmax Compliance 2015-03-23 10:09
    - Change in curve changed the ratio of Cmax nobody 2015-03-23 10:34
      - Change in curve changed the ratio of Cmax Compliance 2015-03-23 10:53
- Change in curve changed the ratio of CmaxOhlbe 2015-03-23 14:13
  - Change in curve changed the ratio of Cmax Compliance 2015-03-23 15:29
    - Change in curve changed the ratio of Cmax nobody 2015-03-23 16:11
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-24 08:15
  - Change in curve changed the ratio of Cmax Compliance 2015-03-24 09:39
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-24 11:05
  - Change in curve changed the ratio of Cmax Compliance 2015-03-25 12:13