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AB ☆ India, 2012-09-12 15:42 (5038 d 06:42 ago) Posting: # 9183 Views: 5,148 |
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Hi All, I could not find any literature on the iscv for Selegiline 5 mg capsule. However, the molecule is said as highly variable (based on articles available on public domain) So is the partial ref replicate design should appropriate? how to derive the sample size without the ISCV? please provide valuable comments and experience on this molecule. Many thanks in advance. — Regards, AB |
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drgunasakaran1 ★★  2012-09-12 16:22 (5038 d 06:02 ago) @ AB Posting: # 9184 Views: 4,261 |
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Dear Mr AB, In one of our pilot study with Selegiline, we had an Intrasubject CV% of 54.3% for Cmax and 61.2% for AUC. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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AB ☆ India, 2012-09-12 18:24 (5038 d 04:00 ago) @ drgunasakaran1 Posting: # 9190 Views: 4,303 |
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Dear Dr Gunasekaran, Many thanks for sharing your experience. May i know are these CVs obtained are from 3 way ref relicate (or) two way crossover and that too from Capsule at 5 mg (or) tablet at a different dose. — Regards, AB |
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drgunasakaran1 ★★ 2012-09-14 15:21 (5036 d 07:03 ago) @ AB Posting: # 9219 Views: 4,167 |
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Dear Mr AB, It was a Two Way Cross over fasting study with 2.5 mg tablets. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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ElMaestro ★★★ Denmark, 2012-09-14 18:06 (5036 d 04:18 ago) @ drgunasakaran1 Posting: # 9224 Views: 4,248 |
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Hello drgunasakaran1 ❝ In one of our pilot study with Selegiline, we had an Intrasubject CV% of 54.3% for Cmax and 61.2% for AUC. I always get a little sceptical when the intraCV seems a lot higher for AUC than for Cmax. I recommend my clients to audit the study whenever it happens, but I do acknowledge that it does happen now and then, though, especially if the study is very small. Did you by an chance look at why? Look at monitor reports, do an audit, check chromatograms near the LLOQ? — Pass or fail! ElMaestro |
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jag009 ★★★ NJ, 2012-09-17 18:50 (5033 d 03:34 ago) @ ElMaestro Posting: # 9228 Views: 4,089 |
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Hi ElMaestro, ❝ I always get a little sceptical when the intraCV seems a lot higher for AUC than for Cmax. Value could be for AUCinf? John |
Ing. Helmut Schütz