qualityassurance
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Jordan,
2020-02-04 11:28

Posting: # 21141
Views: 1,494
 

 Route of administration other than oral for concomitant me­di­cation [Bioanalytics]

Hello all,

We have given concomitant medication to subjects during clinical phase and the route of administration was topical, local (eye drops), IV, IM.

Can anyone suggest me :confused::confused: if it is required to include these medications in concomitant medication experiment if the route of administration is other than oral (e.g. IV, topical, eye drops) during clinical phase?
jag009
★★★

NJ,
2020-02-04 19:43

@ qualityassurance
Posting: # 21145
Views: 807
 

 Route of administration other than oral for concomitant me­di­cation

» We have given concomitant medication to subjects during clinical phase and the route of administration was topical, local (eye drops), IV, IM.
»
» Can anyone suggest me :confused::confused: if it is required to include these medications in concomitant medication experiment if the route of administration is other than oral (e.g. IV, topical, eye drops) during clinical phase?

Not sure if this answers your question(I think so but..):
Why not? For both safety and bioanalytical reasons.

J
Ohlbe
★★★

France,
2020-02-05 10:13

@ qualityassurance
Posting: # 21147
Views: 787
 

 Route of administration other than oral for concomitant me­di­cation

Dear Qualityassurance,

» Can anyone suggest me :confused::confused: if it is required to include these medications in concomitant medication experiment if the route of administration is other than oral (e.g. IV, topical, eye drops) during clinical phase?

I would say it depends on the bioavailability of these products when administered by these routes. For IV, no discussion (at least, if there is an active substance - don't bother about saline or glucose). But for a topical administration the answer is likely that there is no point.

Regards
Ohlbe
Dr_Dan
★★  

2020-02-11 16:20

@ qualityassurance
Posting: # 21159
Views: 668
 

 Route of administration other than oral for concomitant me­di­cation

Dear qualityassurance
In case of a bioequivalence study, it also depends on whether the concomitant medication was
given obligatory to all subjects or was taken accidentally by one or maybe more subjects. In the first case, the effect for the test and the reference formulation would be the same and you do not need to argue. Otherwise, a detailed risk analysis should be carried out, which describes the estimated PK effects of the concomitant medication on the bioequivalence decision. If only a view subjects are affected a sensitivity analysis could be carried out.
I hope this helps.

Kind regards and have a nice day
Dr_Dan
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