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sachin_bhandurge ☆ India, 2013-11-01 08:21 (4618 d 04:46 ago) (edited on 2013-11-01 12:03) Posting: # 11852 Views: 4,324 |
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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] — PREM |
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luvblooms ★★ India, 2013-11-08 07:44 (4611 d 05:22 ago) @ sachin_bhandurge Posting: # 11867 Views: 3,446 |
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Dear Sachin You Should try it like this Samples Required for BE Study (Fasting and Fed): 72 (Dosing (32) + verification purpose (2) and extra dispensed (2) = 36 samples/study) Samples Required for Retention: 2 times of release test (for eg. Release test uses 36 samples you can go for 72 as retention ) Also consider the available pack size showing utilization break up and mention it in your request to DCGI. Eg: Total requirment From above example ~144 But drug is available in pack size of lets say 60, then you ahould apply for 3 packs (3*60=180) Hope this will help Regards — ~A happy Soul~ |
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sachin_bhandurge ☆ India, 2013-11-12 06:12 (4607 d 06:55 ago) (edited on 2013-11-12 09:55) @ luvblooms Posting: # 11868 Views: 3,311 |
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Dear LUV, Thank you very much for ur reply. U gave clear idea about the calculation part it will really help me to calculate samples required for study and retention. Please tel how do we consider release test. Regard's Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! Please also avoid SMS-language [Ohlbe] — PREM |
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luvblooms ★★ India, 2013-11-13 06:04 (4606 d 07:02 ago) @ sachin_bhandurge Posting: # 11871 Views: 3,262 |
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Dear Sachin, ❝ Please tell how do we consider release test. Normally release tests are as per your product release specification and it may comtains following (but not limited to) a) Identification b) Assay c) Relative substance data d) Dissolution e) Content Uniformity f) Microbial assay For release of reference product one need to have atleast following test a) Identification b) Assay c) Relative substance data d) Dissolution You should discuss the same with your QA team to get a better clarity on the same. Regards — ~A happy Soul~ |
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sachin_bhandurge ☆ India, 2013-11-13 13:31 (4605 d 23:35 ago) (edited on 2013-11-13 15:10) @ luvblooms Posting: # 11877 Views: 3,257 |
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Dear Mr.Luv, Thank u very much for the information. Best Regard's SACHIN Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] — PREM |
Ing. Helmut Schütz