Bhupesh
☆    

India,
2008-03-13 12:00

Posting: # 1686
Views: 5,024
 

 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
★★★

France,
2008-03-13 15:17

@ Bhupesh
Posting: # 1687
Views: 4,090
 

 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
☆    

India,
2008-03-14 06:55

@ Ohlbe
Posting: # 1689
Views: 4,086
 

 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........
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