I think any interacting OTC medication would be added in section 7.6 of the trial protocol. for example, OTC NSAIDS may be on the exclusion list for immunotherapy.
For medications that are not expected to interact or interfere with BioA procedures, I would think that the test of the interfering substance would be conducted after the initial evaluation of the patient profile. For example, a departure from the PK profile that can not be attributed to any reasonable effects may be cross-referenced by the clinician with any OTC treatment the patient may have been taking. If a suspect medication is found, the interference can be verified post-validation.
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Ritankar Majumdar
Team Lead, Lead Scientist
LabCorp Inc. - Chantilly, Va
Chantilly VA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 02-13-2023 17:38
From: Timothy Sangster
Subject: Specificity testing - OTC Cocktail
Hi,
I have a couple of related questions.
Are people still doing the OTC cocktail test during in method validation or production?
Specificity testing for compounds taken in a Phase III trial - Are people doing any assessment of the the impact of any materials taken during a study other than the compounds which are co-mediated or on the study inclusion list? If they are what are they doing?
regards
Tim
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Timothy Sangster
Executive Director
Celerion
Lincoln NE
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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