Bad science [Study As­sess­ment]

posted by sam – India, 2013-07-28 11:05 (4365 d 01:11 ago) – Posting: # 11082
Views: 21,298

Dear Helmut:

Totally agree with your suggestions given.
  1. As per your earlier suggestions we have carried out Fed studies before the Fasting study.
  2. We were very happy when our Fed study meets the BE criteria.
  3. But totally depressed by seeming the results of the Fasting Data.
Its also acceptable that the repeating the study will comes out with various doubts in the mind of Regulatory persons and it is also unethical. But as you stated that the chances of variation is more in the Fed compared to the Fasting study. That’s why the questions comes out in our mind that there may be some flaws in the study conduct of the Fasting study.
If we are talking about the formulation problem then why the same is not reflecting in the Fed study.
Also the results of the Fed pilot is similar to the Fed Pivotal.

Few of the results are also provided for your references and give us the final suggestions.

Fed Pivotal Study Results:
Dependent       Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)
Ln(AUCINF_obs)     96          91          102      100     14.5
Ln(AUClast)        96          91          101      100     14.8
Ln(Cmax)           87.91       82           94       99.99  20.3

Fasting Pilot study Data:
Dependent       Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)
Ln(AUCINF_obs)     87.02       69.00      109.75    0.48    37.07
Ln(AUClast)        95.22       77.65      116.76    0.56    32.34
Ln(Cmax)           89.43       77.16      103.66    0.81    23.13

Fasting Pivotal Study results:
Dependent       Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)
Ln(AUCINF_obs)     98          92         103       100     18
Ln(AUClast)        98          92         103       100     18
Ln(Cmax)           79          74          84       100     21


Best Regards
Sam

Edited using BBCodes. Don’t use tabs in your posts. [Helmut]

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