ambulatory sample [Regulatives / Guidelines]
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]
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]
Complete thread:
- ambulatory sample thirupathireddy alla 2010-09-02 06:36 [Regulatives / Guidelines]
- Sampling time deviations Ohlbe 2010-09-02 10:25
- ambulatory sample Helmut 2010-09-02 12:46
- ambulatory sample thirupathireddy alla 2010-09-03 13:33
- ambulatory samplepatilatu 2010-09-22 06:57
- ambulatory sample thirupathireddy alla 2010-09-03 13:33
