US FDA guidance [Bioanalytics]

posted by chandru – India, 2018-05-27 21:41 (876 d 06:44 ago) – Posting: # 18820
Views: 2,411

Hi thank you all for your valuable inputs.

After the release of FDA guidance May 2018, is it mandatory to evaluate stability of molecule in presence of potentially interfering substance?

Is it mandatory to evaluate for all the concomitant medication given to subjects in a particular study or is it ok if we do it for regularly administered drug(eg., Some defined 10 drugs, putting in the SOP and evaluating it) ?

Regards,
Chandru

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