Can we administer ge­neric drug as conco­mi­tant in patient based PK study [Regulatives / Guidelines]

posted by narra1813  – India, 2025-10-14 15:20 (232 d 10:30 ago) – Posting: # 24453
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hi

Can you please advice regulatory views on concomitant medication should be used from FDA approved data base or locally approved generic can be used in Patient based PK study. as this concomitant is will used for reducing severity of AE.
—
Regards

Narra Narendra Babu

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