Period effect [Off Topic]

posted by kumarnaidu – Mumbai, India, 2014-01-28 07:54  – Posting: # 12280
Views: 9,043

Hi all,
If the the drug is highly variable then is it possible that we can get big difference in Cmax and AUC in two period for both test and reference. In one of pilot study I got the results below.

Test Cmax: Period 1 and period 2: 951 and 189 (approx)
Test AUC: Period 1 and period 2: 1700 and 225 (approx)

Reference Cmax: Period 1 and period 2: 830 and 276 (approx)
Reference AUC: Period 1 and period 2: 1500 and 360 (approx)

Edit: Subject line changed. [Helmut]

Kumar Naidu

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