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RegisterHow to show Utilization Break-up [Regulatives / Guidelines]
Dear All,
I wan to conduct Comparative BA study in India,BE for Export purpose for EU market regarding that purpose, I want to Import Investigational Drug products from out of India to conduct Comparative BA studies Fasting with 32 subjects and Fed with 32 subjects.
To apply for Import license we need to show Utilization Break-up as per DCGI norms.
Can you please help me out in calculating and showing Utilization Break-up i.e., No of samples required for the study and No. of sample required for Retention.
I have already calculated as below:
Example: Fasting Study (Test product)
Samples Required for Study:
Dosing (32) + verification purpose (2) and extra dispensed (2) = 36 samples
Samples Required for Retention:
Dissolution Profile (12 ×2 times) = 34 × 2 (time points) = 68 samples
I am confused in calculating No of sample required for retention considering number sample required for dissolution profile, If the above calculation is incorrect I request to give easy formula to calculate the same is meeting regulatory requirements also.
Regards
SACHIN
Edit: identical post in a separate, unrelated thread deleted [Ohlbe]
I wan to conduct Comparative BA study in India,BE for Export purpose for EU market regarding that purpose, I want to Import Investigational Drug products from out of India to conduct Comparative BA studies Fasting with 32 subjects and Fed with 32 subjects.
To apply for Import license we need to show Utilization Break-up as per DCGI norms.
Can you please help me out in calculating and showing Utilization Break-up i.e., No of samples required for the study and No. of sample required for Retention.
I have already calculated as below:
Example: Fasting Study (Test product)
Samples Required for Study:
Dosing (32) + verification purpose (2) and extra dispensed (2) = 36 samples
Samples Required for Retention:
Dissolution Profile (12 ×2 times) = 34 × 2 (time points) = 68 samples
I am confused in calculating No of sample required for retention considering number sample required for dissolution profile, If the above calculation is incorrect I request to give easy formula to calculate the same is meeting regulatory requirements also.
Regards
SACHIN
Edit: identical post in a separate, unrelated thread deleted [Ohlbe]
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Complete thread:
- How to show Utilization Break-upsachin_bhandurge 2013-11-01 07:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- How to show Utilization Break-up luvblooms 2013-11-08 06:44
- How to show Utilization Break-up sachin_bhandurge 2013-11-12 05:12
- How to show Utilization Break-up luvblooms 2013-11-13 05:04
- How to show Utilization Break-up sachin_bhandurge 2013-11-13 12:31
- How to show Utilization Break-up luvblooms 2013-11-13 05:04
- How to show Utilization Break-up sachin_bhandurge 2013-11-12 05:12
- How to show Utilization Break-up luvblooms 2013-11-08 06:44
Ing. Helmut Schütz