Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by jag009  – NJ, 2019-04-15 08:51 (2278 d 01:35 ago) – Posting: # 20160
Views: 6,806

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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