Chloropyramine BE study [Power / Sample Size]

posted by Elena777 – Belarus, 2019-03-13 16:17 (586 d 08:36 ago) – Posting: # 20022
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Dear all! Please share any idea with me. Chloropyramine is an antiallergic drug. We need to conduct BE study with our chloropyramine tablet vs reference Suprastin. But I failed to find any useful data about pharmacokinetics as well as BE reports of other companies and PARs about drugs with such API. My colleagues failed as well. So we have NO information about CVintra and CI for Cmax and AUCt. And we are not able even to suggest anything. There is nothing to rely on in estimation of sample size. Any help will be highly appreciated!

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