BE-proff
★★  

Russia,
2016-09-01 09:05

Posting: # 16618
Views: 5,274
 

 Concomitant medications in BE-study [Study Per­for­mance]

Hi All,

It is well-known fact that concomitant medications are not allowed in BE-studies with healthy volunteers.
But if to look at BE-studies of drug-releasing implants (with very long sampling period) I doubt that subjects will not use any medications (i.e. painkillers for headache or nasal drops).
Should we exclude such subjects from the study even though we know that taken drug have low absorption (nasal drops, topical creams, etc)?

May be there are any publications with list of medications which can used in BE-studies?:confused:
Beholder
★    

Russia,
2016-09-02 11:03

@ BE-proff
Posting: # 16622
Views: 4,415
 

 Concomitant medications in BE-study

Hi BE-proff!

» Should we exclude such subjects from the study even though we know that taken drug have low absorption (nasal drops, topical creams, etc)?

I wonder what is written in your protocol regarding drug intake?

Best regards
Beholder
BE-proff
★★  

Russia,
2016-09-02 22:04

@ Beholder
Posting: # 16626
Views: 4,418
 

 Concomitant medications in BE-study

in 1 protocol???
ElMaestro
★★★

Belgium?,
2016-09-02 16:01

@ BE-proff
Posting: # 16624
Views: 4,463
 

 Concomitant medications in BE-study

Hi BE-proff,

» It is well-known fact that concomitant medications are not allowed in BE-studies with healthy volunteers.

I know what you mean, but I would put it differently. Usually drugs are allowed when they are prescribed/approved/given/suggested by the PI or someone delegated. Otherwise they are not.

» But if to look at BE-studies of drug-releasing implants (with very long sampling period) I doubt that subjects will not use any medications (i.e. painkillers for headache or nasal drops).
» Should we exclude such subjects from the study even though we know that taken drug have low absorption (nasal drops, topical creams, etc)?

It depends on what is written in the protocol, but importantly also what is written in your own QMS. Intake of concurrent meds on the patient's own initiative -which I think is what you are alluding to- is typically a protocol violation. Then the PI or someone delegated needs to consider if this has an impact on the study. This is judgment. Or gut feeling (a term that has become popular on this forum the past few days, for good reason).

Whether it has any impact is specific to the API being tested and to the API being additionally ingested (and how and why and ...). And therefore I don't think there is much help in the literature.

I could be wrong, but...
Best regards,
ElMaestro
BE-proff
★★  

Russia,
2016-09-02 22:04

@ ElMaestro
Posting: # 16625
Views: 4,438
 

 Concomitant medications in BE-study

Hi ElMaestro,

I think it's hardly possible to assess interaction between tested products and concurrent medications...
So, anyway, it's better to remove subjects from a study if they have taken pills not specified in protocols.
Fewer questions from regulators :-D
ElMaestro
★★★

Belgium?,
2016-09-03 11:15

@ BE-proff
Posting: # 16627
Views: 4,387
 

 Concomitant medications in BE-study

Hi again,

» So, anyway, it's better to remove subjects from a study if they have taken pills not specified in protocols.
» Fewer questions from regulators :-D

Remove subjects = more questions, I think. General view only. Your mileage may vary. ;-)

I could be wrong, but...
Best regards,
ElMaestro
Activity
 Admin contact
20,126 posts in 4,245 threads, 1,383 registered users;
online 12 (2 registered, 10 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 21:06 CET

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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