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

Change in curve changed the ratio of Cmax [Bioanalytics]

posted by Compliance – India, 2015-03-23 08:39 (3718 d 14:57 ago) – Posting: # 14588
Views: 13,751

Dear All,

I request to share your comment on below issue:

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.

After completion of repeat study we got ratio of Cmax 87%.

Now my question is does it impacted due to change in method (i.e. linearity) & processing volume? does the observed change in Cmax ratio is logical and acceptable or any doubt on the method can be raised?

Please note that the difference between the concentration obtain during initial analysis and repeat analysis is around 10-12%.

Please advice and share your thought on this matter.

Regards,

Compliance

Complete thread:

Change in curve changed the ratio of CmaxCompliance 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 Cmax Ohlbe 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