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hariemmadi ● 2007-10-25 14:14 (6820 d 08:47 ago) Posting: # 1254 Views: 5,777 |
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i would like to know the intra-subject variability for clonazepam, is tweleve volunteers are enough to conduct the be study Edit: Category changed. [Helmut] |
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ashutoshkumaryadav ☆ Ahmedabad, India, 2008-05-06 16:44 (6626 d 06:17 ago) @ hariemmadi Posting: # 1820 Views: 4,477 |
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Dear Hariemmadi, The maximum ISCV observed in literature is approximately 12 % for cmax. Based on that 12 subjects are sufficient to prove bioequivalence with 80 % power. However considering the dropouts better to enroll two extra subjects. — Thanks and regards Ashutosh Kumar Yadav M.Pharm (Pharmacology) Mob. No. +91-079-9904516032 |
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MGR ★ India, 2008-05-08 12:45 (6624 d 10:16 ago) @ hariemmadi Posting: # 1833 Views: 4,360 |
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Hi Hariemmadi, According to the Intrasubject CV twelve volunteers are ok. But you have to look after the ratio's (point estimate) also. Considering the ratios also, we have to decide the sample size. For suppose if the ratios you are getting around 90 or 110 then the sample size will be more. So be caution regarding this. Thank you. — Regards, MGR |
Ing. Helmut Schütz