ambulatory sample [Regulatives / Guidelines]

posted by patilatu – 2010-09-22 08:57 (5745 d 03:41 ago) – Posting: # 5929
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Actual time of sampling should be used in the estimation of the pharmacokinetic parameters. In studies to determine bioequivalence after a single dose, AUC(0-t), AUC(0-∞), residual area, Cmax and tmax should be determined. In studies with a sampling period of 72 h, and where the concentration at 72 h is quantifiable, AUC(0-∞) and residual area do not need to be reported; it is sufficient to report AUC truncated at 72h, AUC(0-72h).


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see this post! [Helmut]

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