Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-19 11:14 CET (UTC+1h)
 
Bhupesh
Junior

India,
2008-03-13 12:00

Posting: # 1686
Views: 3,445
 

 Failed fasting but passed fed study [Dissolution / BCS / IVIVC]

Dear Friends
Regards :-)
We are working on a BCS class two molecule which is enteric coated. We are getting very good results in Fed pilot study but getting lower T/R% ratios in Fasting study. We checked release in ph 1.2, 2.98 and 4.5 buffer, the drug is not getting released in these media and this is shown in the biostudy also where we are getting a lag time of 1-3 hr.
What may be the reason of this failure in fasting biostudy and how to solve it? :ponder:
Thanks a lot.............
Ohlbe
Hero

France,
2008-03-13 15:17

@ Bhupesh
Posting: # 1687
Views: 2,737
 

 Failed fasting but passed fed study

Dear Bhupesh,

Was the fasting study also a pilot ? If yes, how many subjects, for which intra-subject CV? How much lower are your T/R ratio ?

Regards
Ohlbe
Bhupesh
Junior

India,
2008-03-14 06:55

@ Ohlbe
Posting: # 1689
Views: 2,778
 

 Failed fasting but passed fed study

Dear Ohlbe
Regards
Sorry the drug is BCS class 1 molecule. T/R ratios for fasting pilot
(14 subjects) are Cmax (74%), AUC 0-t (81%) and AUC o-inf (89%). Intrasubject cv was <30% (23%-cmax, 20%-AUC 0-t, 21%-AUC 0-inf). In extrapolation in 60 subjects the drug was still found to be on lower side (with very slight difference from the existing study) but for fed studies we were having Cmax (97%), AUC 0-t (108%) and AUC o-inf (110%) and in extrapolation we are very comfortable.
Please suggest me some solutions........
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,486 Posts in 3,744 Threads, 1,084 registered users;
25 users online (0 registered, 25 guests).

Errors using inadequate data are much less
than those using no data at all.    Charles Babbage

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed