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ashutoshkumaryadav ☆ Ahmedabad, India, 2007-10-10 17:03 (6423 d 00:40 ago) Posting: # 1171 Views: 11,212 |
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As per product information of Prometrium the progesteron is having high intrasubject as well as intersubject variability. However i am not able to find the exact % CV. Can u help me for the calculation of sample size which will be sufficient to proove bioequivalence (Two way crossover design). — Thanks and regards Ashutosh Kumar Yadav M.Pharm (Pharmacology) Mob. No. +91-079-9904516032 |
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MGR ★ India, 2007-12-04 07:40 (6368 d 09:03 ago) @ ashutoshkumaryadav Posting: # 1352 Views: 9,537 |
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Dear Ashutosh, As Progesterone is an highly variable drug that to the intrasubject CV is high the number of subjects for the study will be more (nearly 100), due to variable drug you have to go for four way cross over with less no of subjects when compared to two way crossover. May be this is helpful to you. Thank you, — Regards, MGR |
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ashutoshkumaryadav ☆ Ahmedabad, India, 2007-12-06 13:58 (6366 d 02:44 ago) @ MGR Posting: # 1359 Views: 9,397 |
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Dear MGR, Thanks for your kind reply. You are right we can reduce the sample size by opting 4way crossover design. Conducting a BE study with 100 subject is not an issue. we can go ahead with 100 sample size but for this we need a proper justification. I have gone through a presentation in which 98% ISCV is mentioned, in that case approximately 300 sample size is required. I am not getting any published article for the exact ISCV of progesteron. Do you have any reference for Progesteron ISCV. -- Edit: Full quote removed. Please see this post! [HS] — Thanks and regards Ashutosh Kumar Yadav M.Pharm (Pharmacology) Mob. No. +91-079-9904516032 |
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MGR ★ India, 2007-12-07 07:19 (6365 d 09:24 ago) @ ashutoshkumaryadav Posting: # 1361 Views: 9,613 |
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Hi Ashutosh, You are welcome. And I too don't have the reference for that. I had the same document what you have seen. The link is http://www.fda.gov/OHRMS/DOCKETS/AC/04/slides/4034S2_04_Benet.ppt#312,9,Progesterone The Poster Drug for High Variability. If I get the reference, I will definitely post that. Thank you. — Regards, MGR |
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drshiv ★ India, 2007-12-12 10:43 (6360 d 06:00 ago) @ MGR Posting: # 1365 Views: 9,411 |
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Hi Guys, This study to be conducted involving post-menopausal women. Consider this!!! Dr. Shiv |
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ashutoshkumaryadav ☆ Ahmedabad, India, 2007-12-13 11:12 (6359 d 05:30 ago) @ drshiv Posting: # 1369 Views: 9,714 |
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— Thanks and regards Ashutosh Kumar Yadav M.Pharm (Pharmacology) Mob. No. +91-079-9904516032 |
Ing. Helmut Schütz