rams
☆    

India,
2016-03-15 07:38
(2936 d 09:13 ago)

Posting: # 16103
Views: 6,475
 

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

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
(2936 d 07:03 ago)

@ rams
Posting: # 16104
Views: 5,238
 

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

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
★★★
avatar
Homepage
Vienna, Austria,
2016-03-15 15:32
(2936 d 01:19 ago)

@ Dr_Dan
Posting: # 16105
Views: 5,166
 

 Protocol / SAP?

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 AUC0–∞ (and the fraction covered by AUC0–72) 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 (tmax); use medians instead. False for t½ as well; best would be harmonic means followed by geometric means.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
rams
☆    

India,
2016-03-23 06:31
(2928 d 10:20 ago)

(edited by Ohlbe on 2016-03-23 09:41)
@ Helmut
Posting: # 16130
Views: 4,840
 

 Protocol / SAP?

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]
Ohlbe
★★★

France,
2016-03-23 10:44
(2928 d 06:07 ago)

@ rams
Posting: # 16131
Views: 4,708
 

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

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
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
115 visitors (0 registered, 115 guests [including 11 identified bots]).
Forum time: 16:52 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5