Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by jag009  – NJ, 2019-04-15 06:51 (918 d 11:02 ago) – Posting: # 20160
Views: 3,396

Hi,

» I face a situation in the evaluation of a Bio-equivalence study which was conducted by a reference drug that was given to the subjects at the last month of it's shelf-life...

I had the issue 2 times before w FDA studies. As long as dosing is done there shouldn't be any issues. My studies completed dosing a week before the RLD expiry date.

J

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