Concomitant medications in BE-study [Study Per­for­mance]

posted by ElMaestro  – Belgium?, 2016-09-02 16:01  – Posting: # 16624
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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,

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