Bioequivalence and Bioavailability Forum • Emesis in Steady state BE studies

dk
☆

India,
2014-03-20 12:44
(4478 d 03:30 ago)

(edited on 2014-03-20 14:14)
Posting: # 12678
Views: 5,113

Emesis in Steady state BE studies [Design Issues]

Hi,

I have a question regarding withdrawal criteria in case of emesis in a steady state BE study.

we are planning to conduct a multi site BE study. As per Protocol, subjects will have to consume tablets from Day 1 to Day 8 and then crossed over for other Product. Post-dose PK sampling is planned on Day 8 and and Day 16. we have kept withdrawal criteria if the subjects vomits within 2 times of median Tmax after dosing on Day 8 and 16. However we are not sure if the same withdrawal criteria has to be applied for other days as well i.e. on Day 1 to 7 and Day 9 to day 15. Could somebody please provide answer for this. Also please provide the reference for the same.

Thanks a lot for the help.

Kind Regards
DK

Edit: Category changed. [Helmut]

Tina ★ India, 2014-03-20 16:34 (4477 d 23:40 ago) @ dk Posting: # 12679 Views: 4,182	Emesis in Steady state BE studies Post reply
	According to the FDA Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations, ‘In the case of modified-release products, the data from subjects who experience emesis any time during the labeled dosing interval can be deleted.’ Kind regards, Tina

krish ☆ India, 2014-03-21 06:07 (4477 d 10:06 ago) @ Tina Posting: # 12683 Views: 4,125	Emesis in Steady state BE studies Post reply
	hello Tina, Can you please let me know what does "labeled dosing interval" actually mean. Regards, KRISH

dk
☆

India,
2014-03-21 06:37
(4477 d 09:37 ago)

(edited on 2014-03-21 10:06)
@ krish
Posting: # 12685
Views: 4,114

Emesis in Steady state BE studies

Post reply

Hello Krish,

As far as I understand, labeled dosing interval means the dosage mentioned on the product label. For ex. for a product if the dosage is mentioned as one tablet/capsule per day then the dosage interval for that product is 24 hours.

Kind Regards

Dk

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]

This is post #4000 from India. Congratulations! [Helmut]

dk ☆ India, 2014-03-21 06:31 (4477 d 09:43 ago) (edited on 2014-03-21 10:06) @ Tina Posting: # 12684 Views: 4,137	Emesis in Steady state BE studies Post reply
	Thank You Tina for the reply. Kind Regards DK 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]