Protocol / SAP? [Study As­sess­ment]

posted by rams – India, 2016-03-23 06:31 (3245 d 11:14 ago) – Posting: # 16130
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(edited on 2016-03-23 09:41)

Dear Helmut,

❝ Since you were aware that truncating the AUC is acceptable in most regulations nowadays, why did you calculate AUC0–∞ (and the fraction covered by AUC0–72) at all? What does your protocol / SAP say?


Thank you for writing. in protocol we have included PK parameters are Cmax, AUCt and AUCinf not represented AUC0-72 however our sampling is up to 72 hours only. so that i have a doubt do we hav to confirm or not wether the AUCt covers at least 80% AUCinf.

Thanks & regards,
Rams


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

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