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MGR ★ India, 2007-12-07 14:13 (6774 d 20:33 ago) Posting: # 1362 Views: 5,514 |
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Dear all, Please can anyone tell me the refrences of intrasubject cv of Pramipexole diHCl drug? Thanks in advance Edit: Category changed. [Helmut] — Regards, MGR |
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ashutoshkumaryadav ☆ Ahmedabad, India, 2008-05-06 16:23 (6623 d 19:23 ago) @ MGR Posting: # 1819 Views: 4,512 |
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Dear MGR, I do not have exact ISCV for pramipexol however in NDA Application No. 020667 the inter-subject variability among the pharmacokinetic parameters for Pramipexole was found to be ~30%. The intra-subject variability is generally observed to be lower than inter subject variability. We may expect 25% ISCV and calculate the sample size for the same. — Thanks and regards Ashutosh Kumar Yadav M.Pharm (Pharmacology) Mob. No. +91-079-9904516032 |
Ing. Helmut Schütz