Siswanto
☆    

Indonesia,
2023-08-12 11:18
(625 d 09:55 ago)

Posting: # 23693
Views: 3,464
 

 Zero Data in Suppo­si­tories BE Test [Study As­sess­ment]

Post reply
Dear all,
Some subjects in our BE study of paracetamol suppositories was reported with zero data in reference drug or test drug. The BE lab did not have any idea for the reason and claimed that there were no mistakes in drug delivery method into subject.

Could you please inform us any reason of the problem and how to prevent it?

[image]

Thank you.

Regards,
Siswanto

Edit: Category changed; see also this post #1. [Helmut]
 
dshah
★★  

India,
2023-08-14 18:15
(623 d 02:58 ago)

@ Siswanto
Posting: # 23694
Views: 2,684
 

 Zero Data in Suppositories BE Test

Post reply
Hello Siswanto!

It seems to be the issue with administration. Generally for oral drug- it is checked that dosage is consumed completely and is not spitted. So was the suppository administration monitored and confirmed that subject have not removed them?
Regards,
Divyen
 
Siswanto
☆    

Indonesia,
2023-08-15 04:18
(622 d 16:55 ago)

@ dshah
Posting: # 23695
Views: 2,708
 

 Zero Data in Suppositories BE Test

Post reply
Dear Divyen,
Thank you for your reply.

Single dose of the study drug (equivalent to one suppository), either test or reference according to the randomization code will be administered by Responsible Physician or Study Nurse to the subjects in a lateral position. Then, subjects will be asked to maintain in supine position for at least 4 hours and will be monitored by the study team. If there is any subject who needs to go to the toilet during the time range, subject needs to report to study team and study team will record the time and subject’s purpose (urinate/defecate).

Regards,
Siswanto
 
dshah
★★  

India,
2023-08-15 13:07
(622 d 08:06 ago)

@ Siswanto
Posting: # 23696
Views: 2,738
 

 Zero Data in Suppositories BE Test

Post reply
Hi Siswanto!

❝ If there is any subject who needs to go to the toilet during the time range, subject needs to report to study team and study team will record the time and subject’s purpose (urinate/defecate).


This may help you if the same subject had visited toilet immediately after administration. Hope study team ensure that subjects are complying with protocol after the toilet visit.

Regards,
Divyen
 
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
85 visitors (0 registered, 85 guests [including 4 identified bots]).
Forum time: 21:13 CEST (Europe/Vienna)

There are two possible outcomes: if the result confirms the
hypothesis, then you’ve made a measurement. If the result is
contrary to the hypothesis, then you’ve made a discovery.    Enrico Fermi

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