Bioequivalence and Bioavailability Forum

rams ☆ India, 2016-03-15 07:38 (2956 d 23:47 ago) Posting: # 16103 Views: 6,536	if 75% of the subjects AUCt not covers at least 80% of AUCinf [Study Assessment] Post reply
	What justification we can write if 75% of the subjects AUCt not covers at least 80% of AUCinf. the study sampling is up to 72 hours. the Mean Tmax for Test and Ref is 6.56 and 5.98 the Mean tHalf for Test and Ref is 38.149 and 34.833 Awaiting for adequate response. Best regards, Rams Edit: Category changed. [Helmut]

Dr_Dan
★★

Germany,
2016-03-15 09:49
(2956 d 21:37 ago)

@ rams
Posting: # 16104
Views: 5,286

if 75% of the subjects AUCt not covers at least 80% of AUCinf

Post reply

Dear Rams
According to CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** AUC truncated at 72 h (AUC_(0-72h)) may be used as an alternative to AUC_(0-t) for comparison of extent of exposure as the absorption phase has been covered by 72 h for immediate release formulations. A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug.
So everything is fine.
I hope this helps
Kind regards
Dr_Dan

—
Kind regards and have a nice day
Dr_Dan

Helmut
★★★

Vienna, Austria,
2016-03-15 15:32
(2956 d 15:53 ago)

@ Dr_Dan
Posting: # 16105
Views: 5,214

Protocol / SAP?

Post reply

Dear Dan & Rams,

❝ So everything is fine.

Given the results, yes.

@Rams (nitpicking): Since you were aware that truncating the AUC is acceptable in most regulations nowadays, why did you calculate AUC_0–∞ (and the fraction covered by AUC_0–72) at all? What does your protocol / SAP say?
BTW, I assume that you are referring to arithmetic means? False for PK metrics following a discrete distribution (t_max); use medians instead. False for t_½ as well; best would be harmonic means followed by geometric means.

—
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Helmut Schütz

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rams
☆

India,
2016-03-23 06:31
(2949 d 00:54 ago)

(edited by Ohlbe on 2016-03-23 09:41)
@ Helmut
Posting: # 16130
Views: 4,887

Protocol / SAP?

Post reply

Dear Helmut,

❝ Since you were aware that truncating the AUC is acceptable in most regulations nowadays, why did you calculate AUC_0–∞ (and the fraction covered by AUC_0–72) 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]

Ohlbe ★★★ France, 2016-03-23 10:44 (2948 d 20:41 ago) @ rams Posting: # 16131 Views: 4,756	if 75% of the subjects AUCt not covers at least 80% of AUCinf Post reply
	Dear Rams, ❝ What justification we can write if... ❝ Awaiting for adequate response. You gave all the information needed to write that justification... What is your opinion ? — Regards Ohlbe

if 75% of the subjects AUCt not covers at least 80% of AUCinf [Study As­sess­ment]

if 75% of the subjects AUCt not covers at least 80% of AUCinf

Protocol / SAP?

Protocol / SAP?

if 75% of the subjects AUCt not covers at least 80% of AUCinf

if 75% of the subjects AUCt not covers at least 80% of AUCinf [Study Assessment]