Posting style & incomplete information [Study As­sess­ment]

posted by sam – India, 2013-07-29 08:46 (4363 d 20:06 ago) – Posting: # 11091
Views: 21,317

Dear Helmut,

Thanks for your time.

The heading of the Tables are correct as i have not given the Table for Fed pilot in my previous post but yes ratios of all the three parameters were same as per the pivotal study.

Fed Pilot Study Results (Total Sample szie 18):
Dependent      Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)  n
Ln(AUCINF_obs)     87.39     69.74      108.72      51.0   32.2  14
Ln(AUClast)        81.09     67.57       97.32      65.0   26.3  14
Ln(Cmax)           87.07     67.52      113.11      41.0   37.8  14

Fed Pivotal Study Results (Total Sample szie 48):
Dependent      Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)  n
Ln(AUCINF_obs)     96.45     91.53      101.64     100.0   14.5  44
Ln(AUClast)        95.94     90.95      101.21     100.0   14.8  44
Ln(Cmax)           87.91     81.81       94.47      99.99  20.3  44

Fasting Pilot study Data (Total Sample szie 18):
Dependent      Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)  n
Ln(AUCINF_obs)     87.02     69.00      109.75       0.48  37.07 14
Ln(AUClast)        95.22     77.65      116.76       0.56  32.34 14
Ln(Cmax)           89.43     77.16      103.66       0.81  23.13 14

Fasting Pivotal Study results (Total Sample szie 64)
Dependent      Ratio[%Ref] CI_90_Lower CI_90_Upper Power   CV(%)  n
Ln(AUCINF_obs)     98.26     93.05      103.77     100.0   18.0  61
Ln(AUClast)        98.14     92.84      103.74     100.0   18.3  61
Ln(Cmax)           79.10     74.09       84.45     100.0   21.9  61

I have personally monitored the whole study but there were no observation at that time.

Now the final sample size on which data has been evaluated are given in each tables.

Hope i have given all the information required by you, if not pl let me know so that i can add more if required.

Once again thanks for time and valuable responses.

So pl let me know if i need revisit the CRO and do the Audit. Also suggest me for the main areas where i need to concentrate during the audit so that the root cause of the study failure can be find out and i can prepare the justification for repeating the study.


Regards

Sam

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