Pramipexole: Intrasubject CV [Design Issues]

posted by ashutoshkumaryadav  – Ahmedabad, India, 2008-05-06 16:23 (6625 d 10:39 ago) – Posting: # 1819
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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

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